COMPOSIÇÃO PARA SAÚDE VISUAL COMPREENDENDO ÁCIDOS GRAXOS DE CADEIA MUITO LONGA, E USOS DA MESMA

Description

1 / 83 Composition for visual health comprising very long-chain fatty acids, and uses thereof. Divided from BR112022018122-1, filed on March 11, 2021.

[001] Compositions and methods for treating and / or preventing at least one disease, disorder and / or condition associated with a loss of visual acuity, including, for example, age-related macular degeneration, are disclosed in this document. In some embodiments, the compositions disclosed in this document comprise at least one very long-chain fatty acid selected from C26+ (5n-3) acids, prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing.

[002] Age-related macular degeneration (AMD) is a leading cause of severe visual acuity loss in the United States and Western Europe in people aged 55 years and older. An estimated 1.75 million individuals in the United States have advanced AMD, which accounts for the majority of cases of severe vision loss. An additional 7.3 million people have early AMD, which is generally associated with little or no vision loss but increases the risk of developing AMD. It is associated with a set of clinically recognizable ocular findings that can lead to blindness. These findings include drusen, retinal pigment epithelial (RPE) disorder, including clumping and / or pigment deposition, RPE detachment, geographic atrophy, subretinal neovascularization, and disciform scarring. Not all of these manifestations are necessary for AMD to be considered present.

[003] Compositions for eye health are disclosed in this document, for example, to prevent or treat macular degeneration. In some forms, the compositions disclosed in this document are nutritional or dietary supplement compositions. In some Petition 870260052112, dated 05 / 29 / 2026, p. 9 / 216 2 / 83 embodiments, the compositions are pharmaceutical compositions. In some embodiments, the compositions disclosed in this document may strengthen and / or promote retinal health, for example, by stabilizing and / or treating visual acuity loss in people with specific eye diseases, disorders and / or conditions. In some embodiments, the disclosure refers to antioxidant nutritional supplements comprising a potent vitamin B complex. In some embodiments, administration of the compositions may decrease visual acuity loss, for example, by reducing the risk of developing late- or advanced age-related macular degeneration in patients.

[004] Methods for the treatment and / or prevention of at least one disease, disorder and / or condition associated with loss of visual acuity are also disclosed in this document, the method comprising administering to an individual in need of a composition as disclosed in this document. In some embodiments, the at least one disease, disorder and / or condition associated with a loss of visual acuity is chosen from among age-related macular degeneration (AMD), retinal pigment epithelium atrophy (RPE), atrophy of at least one photoreceptor, drusen, drusenoid pigment epithelial detachment (DPE), diabetic retinopathy, cataract, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration and oxygen-induced retinopathy.

[005] Also disclosed in this document are methods for regression of drusen and / or epithelial drusenoid pigment detachment (EDD), methods for treating and / or preventing retinal pigment epithelium (RPE) atrophy and / or at least one photoreceptor, and methods for treating and / or preventing vision loss and / or improving visual acuity. The methods comprise administering to a needy individual a composition as disclosed in this document. Petition 870260052112, dated 05 / 29 / 2026, p. 10 / 216 3 / 83 FIGURES

[006] FIGURES 1A and 1B show single-dose bioavailability studies in wild-type (WT) mice: (1A) Serum uptake kinetics of C32 (6n-3) (32:6n-3) acid after single-dose gavage feeding of 6 mg / mouse (n = 4 mice / time point) and (1B) uptake in the retina and RPE of 32:6 n-3 after single-dose gavage feeding. No VLCPUFAs were detected in the liver, brain, or RBC membranes at any time point. Data are presented as mean ± SEM (***P < 0.005; **P < 0.01; *P < 0.05).

[007] FIGURES 2A and 2B show repeated-dose bioavailability studies in WT mice: (2A) Accumulation of 32:6 n3 in mouse retina and RPE after 15 d of gavage feeding (n = 6 mice / group) and (2B) Bioaccumulation of 32:6n-3 in serum, RBC, and liver after 15 d of gavage feeding. No VLCPUFA was detectable in the brain. Data are presented as mean ± SEM (***P < 0.005; **P < 0.01; NS: not significant; ND: not detectable).

[008] Figures 3A and 3B show phospholipid analysis of wild-type (WT) mice after 15 days of gavage feeding of VLCPUFA 32:6n-3 (2 mg / day): (3A) Retina and (3B) RPE. Data are presented as mean ± SEM (n=8 mice / group) (p-values: *p<0.05; NS: not significant; ND: not detectable).

[009] Figures 4A and 4B show long-term uptake of 32:6n-3 (2 mg / d per mouse) in Elovl4-conditionally KO (E4cKO) mice from cones and rods: (4A) Accumulation of 32:6n-3 in E4cKO mouse retinas and RPE compared with age-equivalent WT mice after 15 d of gavage feeding (n = 6 mice / group) and (4B) Accumulation of 32:6n-3 in Petition 870260052112, dated 05 / 29 / 2026, p. 11 / 216 4 / 83 liver and RBCs in E4cKO mice compared with age-equivalent WT mice after 15 d of gavage feeding. Data are presented as mean ± SEM (**P < 0.01; NS: not significant; ND: not detectable).

[0010] Definitions of certain terms used in this application are provided below. Unless otherwise defined, all technical and scientific terms used in this document have the normal and common meaning that would be commonly understood by one skilled in the art to which this disclosure pertains.

[0011] As used in this document, a, an and the refer to one or more (i.e., at least one) of the grammatical object of the article.

[0012] As used in this document, the terms Very Long Chain Fatty Acids (VLCFAs) and Very Long Chain Polyunsaturated Fatty Acids (VLCPUFAs) are interchangeable and refer to fatty acids with a chain length greater than 26 carbons (such as 26 to 60 carbons, 26 to 40 carbons, or 26 to 34 carbons), and 3 to 6 double bonds. The proximal carboxylic region of these molecules is composed of 12 to 20 saturated carbon chains, and the distal region (methyl group end) contains 4 or more conjugated methylene cis double bonds.

[0013] As used in this document, C26+ (5n-3) acids (used interchangeably in this document with the term C26+ (5n-3) eicosapentaenoic acids) are very long-chain fatty acids with a chain length of at least 26 carbons, such as 26 to 36 carbons, such as 26, 28, 30, 32 or 34 carbons, and 5 double bonds. C26+ (5n-3) acids may be in the form of an acid, a prodrug thereof, or a pharmaceutically acceptable salt of any of the foregoing. Petition 870260052112, dated 05 / 29 / 2026, p. 12 / 216 5 / 83

[0014] As used in this document, C26+(6n-3) acids (used interchangeably in this document with the term C26+(6n-3) docosahexaenoic acids) are very long-chain fatty acids with a chain length of at least 26 carbons, such as from 26 to 36 carbons, and 6 double bonds. C26+(6n-3) acids may be in the form of an acid, a prodrug thereof, or a pharmaceutically acceptable salt of any of the foregoing.

[0015] As used in this document, the administration of a daily amount of a cited element or composition refers to the total amount administered in a day, but does not limit the frequency of administration per day. The daily amount administered to a patient may be administered once or several times in a day, such as twice a day or three times a day (wherein each of the multiple administrations comprises administering some amount of a cited element or composition that is less than the daily amount, given that the daily amount refers to the total amount administered in a day). Each administration of a cited element or composition may consist of administering the cited element or composition in the form of a single dose (e.g., such as a single tablet or a single capsule) or in the form of multiple doses (e.g., such as multiple (i.e., two or more) tablets and / or capsules).

[0016] As used in this document, the terms treat and treatment include the medical control of an individual's disease, disorder, and / or condition as would be understood by one skilled in the art (see, e.g., Stedman's Medical Dictionary). In general, an appropriate dose and treatment regimen provide at least one of the compositions of this disclosure sufficient to provide therapeutic and / or prophylactic benefit. For therapeutic treatment and prophylactic or preventive measures, therapeutic and / or prophylactic benefit includes, for example, an improved clinical outcome, where the object is to prevent or Petition 870260052112, dated 05 / 29 / 2026, page 13 / 216 6 / 83 To delay or lessen an undesirable physiological change or disturbance, or to prevent or delay or lessen the expansion or severity of such a disturbance. As discussed in this document, beneficial or desired clinical outcomes of an individual's treatment include, but are not limited to: reduction, diminution, or relief of symptoms resulting from or associated with the disease, condition, and / or disorder being treated; decreased occurrence of symptoms; improved quality of life; longer symptom-free state (i.e., decreasing the likelihood or propensity that an individual will present symptoms upon which a disease diagnosis is based); decreased extent of the disease, disorder, and / or condition; stabilized state (i.e., not worsening) of the disease, disorder, and / or condition; delay or retardation of the progression of a disease, disorder, and / or condition; improvement or palliation of the state of a disease, disorder, and / or condition; and remission (partial or total), whether detectable or undetectable; and / or overall survival.

[0017] As used in this document, prevention of or preventing a disorder or condition refers to reducing or lowering the occurrence of the disorder or condition in a treated sample relative to an untreated control sample and includes delaying the onset, progression, or reduction in the severity of one or more symptoms of the disorder or condition relative to the untreated control sample.

[0018] As used in this document, the term pharmaceutically acceptable salt refers to a salt form of a compound wherein the salt is non-toxic and includes such salts derived from suitable inorganic and organic acids and bases. Pharmaceutically acceptable salts are well known in the art. For example, SM Berge, et al. describe pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences, 1977, 66, 1-19. Non-limiting examples of suitable pharmaceutically acceptable acid addition salts include clo Petition 870260052112, dated 05 / 29 / 2026, page 14 / 216 7 / 83 phosphates, bromides, sulfates, nitrates, phosphates, sulfonates, methane sulfonates, formates, tartrates, maleates, succinates, malonates, citrates, benzoates, salicylates, and ascorbates. Non-limiting examples of suitable pharmaceutically acceptable base addition salts include sodium, potassium, lithium, ammonium (substituted and unsubstituted), calcium, magnesium, iron, zinc, copper, manganese, and aluminum salts. Non-limiting examples of pharmaceutically acceptable salts include pharmaceutically acceptable salts derived from appropriate bases and include alkali metal, alkaline earth metal, ammonium, and N+(C1-4alkyl)4 salts. This disclosure also provides for the quaternization of any basic nitrogen-containing groups of the compounds disclosed herein. Pharmaceutically acceptable salts may, for example, be obtained using standard procedures well known in the pharmaceutical field.A person skilled in the art will recognize that the stability and other properties of different pharmaceutically acceptable salts of the components mentioned in this document may differ and will consider these differences when selecting suitable pharmaceutically acceptable salts.

[0019] The terms patient, individual, person and the like, as used in this document, are interchangeable and refer to any animal, which may be a human or non-human animal.

[0020] As used in this document, age-related macular degeneration or AMD includes all forms of macular degeneration, including wet (exudative) and dry (atrophic) forms.

[0021] The term prodrug includes compounds that can be converted (e.g., under physiological conditions or by solvolysis) into a biologically active compound. Thus, the term prodrug includes metabolic precursors of compounds that are pharmaceutically acceptable. A discussion of prodrugs can be found, for example, in Higuchi, T., et al., Pro-drugs as Novel Delivery Systems, ACS Petition 870260052112, dated 05 / 29 / 2026, p. 15 / 216 8 / 83 Symposium Series, Vol. 14, and in Bioreversible Carriers in Drug Design, ed. Edward B. Roche, American Pharmaceutical Association and Pergamon Press, 1987. The term prodrug also includes covalently linked carriers that release the active compounds, as described in this document, in vivo when such a prodrug is administered to an individual. Non-limiting examples of prodrugs include ester and amide derivatives of hydroxy, carboxy, mercapto, and amino functional groups in the compounds described in this document.

[0022] The term nutritional composition, as used in this document, includes a food product intended for human consumption.

[0023] As will be understood by one skilled in the art, when disclosed in this document, each interval includes all possible subintervals as well as individual numerical values ​​within that interval. For example, an interval from 1.0 to 5.0 includes and would be understood as specifically disclosing subintervals such as 1.0 to 3.0, 1.5 to 3.7, 2.1 to 4.3, etc., as well as all individual numbers within the disclosed interval, for example, 1.0, 1.1, 1.2, 1.3, etc.

[0024] Compositions comprising at least one very long-chain fatty acid selected from C26+ (5n-3) acids, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing are disclosed in this document. In some embodiments, the at least one very long-chain fatty acid selected from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any or more of these.

[0025] In some embodiments, the composition further comprises at least one additional component selected from at least one very long-chain fatty acid selected from C26+ (6n-3) acids, prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing; docosahexaenoic acid, prodrugs of Petition 870260052112, dated 05 / 29 / 2026, p. 16 / 216 9 / 83 same and / or pharmaceutically acceptable salts of any of the above items; eicosapentaenoic acid, prodrugs thereof and / or pharmaceutically acceptable salts of any of the above.

[0026] In some embodiments, the composition further comprises at least one additional component selected from at least one very long-chain fatty acid selected from C26+ (6n-3) acids, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing; docosahexaenoic acid, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; eicosapentanoic acid, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; vitamin C, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; vitamin E, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; zinc, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; copper, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the above items;lutein, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing; and zeaxanthin, prodrugs thereof, and / or pharmaceutically acceptable salts of any of the foregoing.

[0027] In some embodiments, the composition comprises 0.1 mg to 1000.0 mg of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the composition comprises 1.0 mg to 900.0 mg of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. Petition 870260052112, dated 05 / 29 / 2026, p. 17 / 216 10 / 83 Ü26+ (5n-3) or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the composition comprises 100.0 mg to 500.0 mg of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the composition comprises 200.0 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs.In some embodiments, the composition comprises 40.0 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, the composition comprises 40.0 mg of C30 (5n-3) acid. In some embodiments, the composition comprises 40.0 mg of C34 (5n-3) acid. In some embodiments, the at least one very long-chain fatty acid selected from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0028] In some embodiments, the composition comprises from about 1 mg to about 1000 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, the composition comprises from about 10 mg to about 250 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of Petition 870260052112, dated 05 / 29 / 2026, p. 18 / 216 11 / 83 a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the composition comprises about 200 mg to about 250 mg of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the composition comprises about 200 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs.In some embodiments, at least one very long-chain fatty acid chosen from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0029] In some embodiments, the composition comprises from about 1 mg to about 100 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, the composition comprises from about 1 mg to about 50 mg of at least one very long-chain fatty acid, such as from about 10 mg to about 50 mg, from about 10 mg to about 40 mg, from about 20 mg to about 40 mg, from about 20 mg to about 30 mg, from about 30 mg to about 40 mg, of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids or an equivalent amount of a pharmaceutically acceptable prodrug salt. Petition 870260052112, dated 05 / 29 / 2026, p. 19 / 216 12 / 83 and / or a pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, the composition comprises about 50 mg to about 100 mg, such as about 50 mg to about 75 mg, about 60 mg to about 90 mg, about 55 mg to about 85 mg, about 70 mg to about 95 mg, or about 65 mg to about 80 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, at least one very long-chain fatty acid chosen from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0030] In some embodiments, the composition comprises from about 100 mg to about 1000 mg, such as from about 150 mg to about 900 mg, from about 250 mg to about 800 mg, from about 350 mg to about 700 mg, from about 450 mg to about 600 mg, or from about 500 mg to about 550 mg, of at least one very long chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of at least one very long chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, at least one very long-chain fatty acid chosen from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0031] In some embodiments, the composition comprises 0.1 mg, 0.25 mg, 0.5 mg, 0.6 mg, 0.75 mg, 0.9 mg, 1 mg, 2.5 mg, 3 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, Petition 870260052112, dated 05 / 29 / 2026, page 20 / 216 13 / 83 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg,275 mg, 300 mg, 325 mg, 350 mg, 375 mg, 400 mg, 425 mg, 450 mg,475 mg, 500 mg, 525 mg, 550 mg, 575 mg, 600 mg, 625 mg, 650 mg,675 mg, 700 mg, 725 mg, 750 mg, 775 mg, 800 mg, 825 mg, 850 mg,875 mg, 900 mg, 925 mg, 950 mg, 975 mg, or 1000 mg of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt, and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (5n-3) acids. In some embodiments, the at least one very long-chain fatty acid chosen from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0032] In some embodiments, the composition comprises more than zero but less than 3 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids. In some embodiments, the at least one very long-chain fatty acid selected from C26+ (5n-3) acids is a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid, a C34 (5n-3) acid, or a mixture of any one or more of these.

[0033] In some embodiments, the composition further comprises 1.0 mg to 1000.0 mg of at least one additional component selected from at least one very long-chain fatty acid selected from C26+ (6n-3) acids, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing. In some embodiments, the composition further comprises 150.0 mg to 250.0 mg of acid Petition 870260052112, dated 05 / 29 / 2026, p. 21 / 216 14 / 83 docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of docosahexaenoic acid. In some embodiments, the composition further comprises 35.0 mg to 45.0 mg of eicosapentanoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of eicosapentanoic acid.

[0034] In some embodiments, the composition further comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug. In some embodiments, the composition further comprises 50.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug. In some embodiments, the composition further comprises 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a zinc prodrug. In some embodiments, the composition further comprises 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug.In some embodiments, the composition further comprises 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug. In some embodiments, the composition further comprises 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. Petition 870260052112, dated 05 / 29 / 2026, p. 22 / 216 15 / 83

[0035] In some modalities, the composition includes: 20.0 mg of at least one C26-34 (5n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[0036] In some modalities, the composition includes: 30.0 mg of at least one C26-34 (5n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[0037] In some modalities, the composition includes: 40.0 mg of at least one C26-34 (5n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[0038] In some modalities, the composition includes: 20.0 mg to 40.0 mg of at least one C26-34 (5n-3) acid; 450.0 mg of vitamin C, optionally in the form of ascorbic acid; 100.0 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; and 80.0 mg of zinc.

[0039] In some modalities, the composition includes: 40.0 mg of at least one C26-34 (5n-3) acid; 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[0040] In some modalities, the composition includes: 40.0 mg of at least one C26-34 (5n-3) acid; 500.0 mg of vitamin C, optionally in the form of ascorbic acid; Petition 870260052112, dated 05 / 29 / 2026, page 23 / 216 16 / 83 180.0 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; optionally up to 200.0 mg of at least one C26-34 (6n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[0041] In some forms, the composition also includes 10.0 mg of lutein and 2.0 mg of zeaxanthin.

[0042] In some embodiments, the composition further comprises about 150 mg to about 250 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a docosahexaenoic acid prodrug.

[0043] In some embodiments, the composition further comprises about 35 mg to about 45 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid.

[0044] In some embodiments, the composition further comprises approximately 350 mg to approximately 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug.

[0045] In some embodiments, the composition further comprises from about 50 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug.

[0046] In some modalities, the composition also includes Petition 870260052112, dated 05 / 29 / 2026, p. 24 / 216 17 / 83 approximately 20 mg to approximately 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug.

[0047] In some embodiments, the composition further comprises about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug.

[0048] In some embodiments, the composition further comprises about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.

[0049] In some embodiments, the composition further comprises from about 1 mg to about 20 mg, such as from about 1.5 mg to about 2.5 mg, of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[0050] In some embodiments, the composition further comprises from about 1 mg to about 1000 mg of at least one very long-chain fatty acid selected from C26+ (6n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (6n-3) acids.

[0051] In some embodiments, the composition comprises: approximately 20 mg of at least one C26-34 (5n-3) acid; about 200 mg of docosahexanoic acid; and about 40 mg of eicosapentaenoic acid.

[0052] In some embodiments, the composition comprises: approximately 30 mg of at least one C26-34 (5n-3) acid; about 200 mg of docosahexanoic acid; and Petition 870260052112, dated 05 / 29 / 2026, p. 25 / 216 18 / 83 about 40 mg of eicosapentaenoic acid.

[0053] In some modalities, the composition includes: approximately 40 mg of at least one C26-34 (5n-3) acid; about 200 mg of docosahexanoic acid; and about 40 mg of eicosapentaenoic acid.

[0054] In some modalities, the composition includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 200 mg of docosahexanoic acid; approximately 40 mg of at least one C26-34 (5n-3) acid; and approximately 40 mg of eicosapentaenoic acid.

[0055] In some modalities, the composition includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 200 mg of docosahexanoic acid; approximately 40 mg of at least one C26-34 (5n-3) acid; and approximately 40 mg of eicosapentaenoic acid.

[0056] In some modalities, the composition includes: approximately 20 mg to approximately 40 mg of at least one C26-34 (5n-3) acid; approximately 450 mg of vitamin C, optionally in the form of ascorbic acid; approximately 100 mg of vitamin E, optionally in the form of acetate Petition 870260052112, dated 05 / 29 / 2026, p. 26 / 216 19 / 83 dl-alpha tocopheryl; and approximately 80 mg of zinc, optionally in the form of zinc oxide.

[0057] In some forms, the compositions still include about 10 mg of lutein and about 2 mg of zeaxanthin.

[0058] In some embodiments, the composition comprises at least one C26-34 (5n-3) acid, which may be C26 (5n-3) acid or C28(5n-3) acid (ΈPA (28C), below) and / or C30(5n-3) acid (EPA (30C), below), which are shown in Scheme 1 below: Diagram 1.

[0059] Additional information can be found, for example, in Do et al.PNAS,116(48), 24317-24325 (2019), which is incorporated herein by reference in full.

[0060] In some embodiments, the composition comprises from 0.1 mg to 250 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts, and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; 150.0 mg to 250.0 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; and 35.0 mg to 45.0 mg of eicosapentaenoic acid or Petition 870260052112, dated 05 / 29 / 2026, page 27 / 216 20 / 83 an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid.

[0061] In some embodiments, the composition comprises from 0.2 mg to 200 mg of at least one C26+ (5n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentanoic acid.

[0062] In some embodiments, the compositions disclosed in this document also comprise lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein. In some embodiments, the lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein is R',R'-lutein. Lutein is a carotenoid. In some embodiments, the composition comprises from 5.0 mg to 50.0 mg, such as 5.0 mg to 15.0 mg, of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.In some embodiments, the composition comprises 5.0 mg to 50.0 mg, such as 6.0 mg to 40.0 mg, 7.0 mg to 30.0 mg, 8.0 mg to 20.0 mg, 9.0 mg to 11.0 mg, 20.0 mg to 30.0 mg, 30.0 mg to 40.0 mg, 40.0 mg to 50.0 mg, 5.0 mg to 15.0 mg, 6.0 mg to 14.0 mg, 7.0 mg to 13.0 mg, 8.0 mg to 12.0 mg, 9.0 mg to 11.0 mg, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, or 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a salt A pharmaceutically acceptable form of a lutein prodrug. In some embodiments, the composition comprises 10.0 mg of lutein.

[0063] In some embodiments, the compositions disclosed in this document further comprise zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin. In some embodiments, the zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin is R',R'-zeaxanthin. Zeaxanthin is a carotenoid. In some embodiments, the composition comprises Petition 870260052112, dated 05 / 29 / 2026, page 28 / 216 21 / 83 0.01 mg to 40.0 mg, such as 1.5 mg to 2.5 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the composition comprises from 0.04 mg to 40.0 mg, such as 1.0 mg to 30.0 mg, 3.0 mg to 25.0 mg, 5.0 mg to 20.0 mg, 10.0 mg to 20.0 mg, 1.0 mg to 15.0 mg, 3.0 mg to 12.0 mg, 5.0 mg to 20.0 mg, 7.0 mg to 19.0 mg, 8.0 mg to 15.0 mg, 1.5 mg to 2.5 mg, 1.5 mg to 2.0 mg, 2.0 mg to 2.5 mg, or 2.0 mg, of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some formulations, the composition includes 2.0 mg of zeaxanthin.

[0064] In some embodiments, the compositions disclosed in this document comprise about 150 mg to about 250 mg of at least one C26+ (6n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts, and / or pharmaceutically acceptable salts of C26+ (6n-3) acid prodrugs; about 150 mg to about 250 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; about 35 mg to about 45 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts, and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; and approximately 35 mg to approximately 45 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid.

[0065] In some embodiments, the composition comprises approximately 20 mg of C32 (5n-3) acid; approximately 200 mg of docosahexaenoic acid; and approximately 40 mg of eicosapentaenoic acid. Petition 870260052112, dated 05 / 29 / 2026, p. 29 / 216 22 / 83

[0066] In some embodiments, the compositions disclosed in this document also comprise lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein. In some embodiments, the lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein is R',R'-lutein. Lutein is a carotenoid. In some embodiments, the composition comprises about 5 mg to about 50 mg, such as about 5 mg to about 15 mg, of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.In some embodiments, the composition comprises from about 5 mg to about 50 mg, such as about 5 mg to about 15 mg, about 6 mg to about 40 mg, about 6 mg to about 14 mg, about 7 mg to about 30 mg, about 7 mg to about 13 mg, about 8 mg to about 20 mg, about 8 mg to about 12 mg, about 9 mg to about 11 mg, about 20 mg to about 30 mg, about 30 mg to about 40 mg, about 40 mg to about 50 mg, about 10 mg, about 20 mg, about 30 mg, about 40 mg, or about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of Lutein. In some forms, the composition includes approximately 10 mg of lutein.

[0067] In some embodiments, the compositions disclosed in this document further comprise zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin. In some embodiments, the zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin is R',R'-zeaxanthin. Zeaxanthin is a carotenoid. In some embodiments, the composition comprises from about 1 mg to about 20 mg, such as from about 1.5 mg to about 2.5 mg, of zeaxanthin or an equivalent amount of a prodrug. Petition 870260052112, dated 05 / 29 / 2026, p. 30 / 216 23 / 83 maco, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the composition comprises from about 1 mg to about 20 mg, such as about 1 mg to about 3 mg, about 3 mg to about 5 mg, about 1.5 mg to about 2.5 mg, such as about 1.5 mg to about 2 mg, about 2 mg to about 2.5 mg, about 5 mg to about 7 mg, about 7 mg to about 9 mg, about 9 mg to about 11 mg, about 11 mg to about 13 mg, about 13 mg to about 15 mg, about 15 mg to about 17 mg, about 17 mg to about 19 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 10 mg, or about 20 mg of zeaxanthin or an equivalent amount of a prodrug, a salt pharmaceutically acceptable, and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the composition comprises approximately 2 mg of zeaxanthin.

[0068] In some embodiments, the compositions described in this document are dietary or nutritional supplements or pharmaceutical compositions. In some embodiments, the compositions may be in the form of a food product, a component of a food product. In some embodiments, the compositions of this disclosure may be used in methods to improve an individual's health. In some embodiments, the compositions described in this document are pharmaceutical compositions.

[0069] In some embodiments, the composition is formulated in a form suitable for oral, intraocular, intraperitoneal, intravenous, subcutaneous, sublingual, transcutaneous and / or intramuscular administration. In some embodiments, intraocular administration is chosen from intravitreal injection and suprachoroidal injection. In some embodiments, the composition is formulated in a form suitable for administration. Petition 870260052112, dated 05 / 29 / 2026, p. 31 / 216 24 / 83 Oral administration. Suitable non-limiting solid oral formulations include tablets, capsules, sachets, lozenges, powders, pills, granules, and pellets. Suitable non-limiting liquid oral formulations include solutions, suspensions, dispersions, emulsions, and oils. In some embodiments, the composition is in liquid, semi-solid, or solid form. For example, compositions may be administered as tablets, gel packs, capsules, gelatin capsules, flavored drinks, or as a powder that can be reconstituted. In some embodiments, the composition is in the form of a tablet, capsule, soft gel, liquid, or powder. In some embodiments, the composition is a soft gelatin capsule and a hard gelatin capsule.

[0070] In some embodiments, the composition is in the form of a chewable oral formulation, such as a chewable tablet.

[0071] In some embodiments, the composition is in the form of an immediate-release formulation or a modified-release formulation, such as a delayed-release and / or extended-release formulation.

[0072] In some embodiments, the compositions may further comprise at least one pharmaceutically acceptable excipient. Non-limiting examples of suitable excipients include surfactants, humectants, plasticizers, binders, crystallization inhibitors, wetting agents, bulking agents, solubilizers, bioavailability enhancers, pH adjusting agents, and flavorings. The term "at least one pharmaceutically acceptable excipient," as used in this document, also includes any and all solvents, diluents, other liquid vehicles, dispersing aids, suspending aids, surfactants, isotonic agents, thickening agents, emulsifying agents, preservatives, solid binders, and lubricants, as appropriate to the specific dosage form desired. Remington: The Science and Practice of Pharmacy, 21st edition, Petition 870260052112, dated 05 / 29 / 2026, page 32 / 216 25 / 83 The 2005 edition by D.B. Troy, Lippincott Williams & Wilkins, Philadelphia, and the Encyclopedia of Pharmaceutical Technology, published by J. Swarbrick and J.C. Boylan, 1988–1999, Marcel Dekker, New York, discloses various excipients used in the formulation of oral compositions and known techniques for their preparation. Except to the extent that any conventional carrier is incompatible with the vitamins of this disclosure, such as by producing any undesirable biological effect or otherwise interacting deleteriously with any other components of the composition, its use is contemplated as being within the scope of this disclosure. Non-limiting examples of suitable pharmaceutically acceptable excipients include, without limitation, ion exchangers, alumina, aluminum stearate, lecithin, serum proteins (such as human serum albumin), buffering substances (such as phosphates, glycine, sorbic acid and potassium sorbate), partial mixtures of glycerides of saturated vegetable fatty acids,Water, salts and electrolytes (such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride and zinc salts), colloidal silica, magnesium trisilicate, polyvinylpyrrolidone, polyacrylates, waxes, polyethylene-polyoxypropylene block polymers, wool fat, sugars (such as lactose, glucose and sucrose), starches (such as corn starch and potato starch), cellulose and its derivatives (such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate), tragacanth powder, malt, gelatin, talc, excipients (such as cocoa butter and suppository waxes), oils (such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil), glycols (such as propylene glycol and polyethylene glycol), esters (such as ethyl oleate and ethyl laurate), agar, buffering agents (such as magnesium hydroxide and aluminum hydroxide), alginic acid, pyrogen-free water, isotonic saline solution,Ringer's solution, ethyl alcohol, phosphate buffer solutions, compatible non-toxic lubricants (such as lauryl, Petition 870260052112, dated 05 / 29 / 2026, page 33 / 216 26 / 83 sodium sulfate and magnesium stearate), coloring agents, release agents, coating agents, sweetening agents, flavoring agents, fragrance agents, preservatives and antioxidants.

[0073] In some embodiments, the compositions may also comprise or be co-administered with at least one additional active ingredient. In some embodiments, the at least one additional therapeutic agent is chosen from among anti-inflammatory agents (e.g., anti-IL-6 agents, anti-IL-8 agents, aspirin, ibuprofen, and naproxen), anti-angiogenic agents (e.g., anti-VEGF agents, ranibizumab, bevacizumab, acadesin, and AMPK activators), antioxidant agents (e.g., vitamin C, vitamin E, vitamin A, glutathione, catalase, etc.), omega-3 fatty acids (e.g., alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)), and vitamins and minerals (e.g., vitamin C, vitamin E, vitamin A, lutein, zeaxanthin, zinc, and copper). In some forms, the composition also includes lutein and zeaxanthin.

[0074] In some embodiments, the compositions may be co-administered with at least one additional composition comprising vitamin C, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the foregoing; vitamin E, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the foregoing; zinc, a prodrug thereof and / or a pharmaceutically acceptable form of any of the foregoing; and copper, a prodrug thereof and / or a pharmaceutically acceptable form of any of the foregoing. In some embodiments, the additional composition comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 150.0 mg to 550.0 mg of vitamin E or an amount Petition 870260052112, dated 05 / 29 / 2026, p. 34 / 216 27 / 83 equivalent of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug; 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a zinc prodrug; 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a copper prodrug; 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a lutein prodrug;and / or 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the additional composition comprises about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug; about 50 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug; about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a zinc prodrug;approximately 1.5 mg to approximately 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a copper prodrug; approximately 5 mg to approximately 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or approximately 1 mg to approximately 20 mg of zeaxanthin or an equivalent amount; Petition 870260052112, dated 05 / 29 / 2026, page 35 / 216 28 / 83 equivalent of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[0075] In some embodiments, the compositions may be co-administered with at least one additional composition comprising vitamin C, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the foregoing; vitamin E, a prodrug thereof and / or a pharmaceutically acceptable salt of any of the above; zinc, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above; and copper, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above. In some embodiments, the additional composition comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 150.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug;20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a zinc prodrug; 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a copper prodrug; 5.0 mg to 15.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or 1.5 mg to 2.5 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug of; Petition 870260052112, dated 05 / 29 / 2026, page 36 / 216 29 / 83 zeaxanthin. In some embodiments, the additional composition comprises from about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug; from about 50 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug; from about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a zinc prodrug; from about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form, and / or a pharmaceutically acceptable salt of a copper prodrug;approximately 5 mg to approximately 15 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or approximately 1.5 mg to approximately 2.5 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[0076] The combination of the disclosed compositions and at least one additional active ingredient may advantageously produce one or more of the following effects: (1) additive and / or synergistic benefits; (2) reduction of side effects and / or adverse effects associated with the use of the prescribed medication in the absence of the compositions disclosed in this document; and / or (3) ability to reduce the dosage of the prescribed medication compared to the amount of prescribed medication required in the absence of the compositions disclosed in this document.

[0077] As disclosed above, in some modalities, the Petition 870260052112, dated 05 / 29 / 2026, p. 37 / 216 30 / 83 compositions may further comprise or be co-administered with at least one additional active ingredient. In some embodiments, the at least one additional active ingredient may be chosen from vitamins and minerals. In some embodiments, the at least one additional active ingredient is chosen from vitamin C, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing; Vitamin E, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; Zinc, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; copper, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B1, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B2, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B3, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B5, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B6, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B7, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B9, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; vitamin B12, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items; lutein, prodrugs thereof, and pharmaceutically acceptable salts. Petition 870260052112, dated 05 / 29 / 2026, p. 38 / 216 31 / 83 of any of the above; and zeaxanthin, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items.

[0078] In some embodiments, vitamin C, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise ascorbic acid. In some embodiments, vitamin E, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise dl-alpha tocopheryl acetate and / or alpha-tocopherol. In some embodiments, zinc, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise zinc oxide and / or zinc gluconate. In some embodiments, copper, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise copper oxide and / or copper gluconate. In some embodiments, vitamin B1, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise thiamine.In some embodiments, vitamin B2, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing comprise riboflavin. In some embodiments, vitamin B3, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing comprise nicotinic acid and / or niacinamide. In some embodiments, vitamin B5, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing comprise pantothenic acid. In some embodiments, vitamin B6, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing comprise pyridoxine. In some embodiments, lutein, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise lutein (R'R'). In some embodiments, zeaxanthin, prodrugs thereof, and salts. Petition 870260052112, dated 05 / 29 / 2026, p. 39 / 216 32 / 83 pharmaceutically acceptable versions of any of the above items comprise zeaxanthin (R'R'). In some embodiments, vitamin B7, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise biotin. In some embodiments, vitamin B9, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise folic acid and / or methyl tetrahydrofolate. In some embodiments, vitamin B12, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise cyanocobalamin.

[0079] In some embodiments, the composition also includes vitamin C, optionally in the form of ascorbic acid; vitamin E, optionally in the form of dl-alpha tocopheryl acetate; zinc, optionally in the form of zinc oxide; thiamine; copper, optionally in the form of copper oxide; riboflavin; vitamin B3, optionally in the form of nicotinic acid and / or niacinamide; pyridoxine; biotin, folate, folic acid and / or methyl tetrahydrofolate; and vitamin B12, optionally in the form of cyanocobalamin. In some embodiments, the composition also includes lutein and zeaxanthin.

[0080] In some embodiments, vitamin C, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise ascorbic acid. In some embodiments, vitamin C, prodrugs thereof, and pharmaceutically acceptable salts of any of the above are ascorbic acid. The US recommended dietary allowance (RDA) for vitamin C in the form of ascorbic acid is 60 mg. In some embodiments, the composition further comprises 60 mg to 850 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug. In some embodiments, the composition further comprises 100.0 mg to 800.0 mg, as well as 150.0 mg to 800.0 mg. Petition 870260052112, dated 05 / 29 / 2026, p. 40 / 216 33 / 83 mg, 250.0 mg to 800.0 mg, 250.0 mg to 750.0 mg, 500.0 mg to 775.0 mg, 600.0 mg to 750.0 mg, 500.0 mg, or 750.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug. In some embodiments, the composition comprises 500.0 mg of vitamin C, optionally in the form of ascorbic acid. In some embodiments, the composition further comprises from about 60 mg to about 850 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug.In some embodiments, the composition further comprises from about 100 mg to about 800 mg, such as about 150 mg to about 800 mg, about 250 mg to about 800 mg, about 250 mg to about 750 mg, about 500 mg to about 775 mg, about 600 mg to about 750 mg, about 500 mg, or about 750 mg, of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin C prodrug. In some embodiments, the composition comprises about 500 mg of vitamin C, optionally in the form of ascorbic acid.

[0081] In some embodiments, vitamin E, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise alpha-tocopherol. In some embodiments, vitamin E, prodrugs thereof, and pharmaceutically acceptable salts of any of the above are dl-alpha tocopheryl acetate. The RDA for vitamin E is 15.0 mg. No adverse effects of vitamin E have been observed at levels as high as 800.0 mg. In some embodiments, the composition further comprises from 15.0 mg to 800 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a Petition 870260052112, dated 05 / 29 / 2026, p. 41 / 216 34 / 83 vitamin E prodrug. In some embodiments, the composition further comprises from 15.0 mg to 800.0 mg of vitamin E, such as 50.0 mg to 750.0 mg, 90.0 mg to 600.0 mg, 180.0 mg to 500.0 mg, 250.0 mg to 400.0 mg, 300.0 mg to 350.0 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug. In some embodiments, the composition further comprises 180 mg of vitamin E. In some embodiments, the composition further comprises from about 15 mg to about 800 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug.In some embodiments, the composition further comprises from about 15 mg to about 800 mg of vitamin E, such as from about 50 mg to about 750 mg, from about 90 mg to about 600 mg, from about 180 mg to about 500 mg, from about 250 mg to about 400 mg, from about 300 mg to about 350 mg of vitamin E, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin E prodrug. In some embodiments, the composition further comprises about 180 mg of vitamin E.

[0082] In some embodiments, zinc, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above comprises zinc oxide. In some embodiments, zinc, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above is zinc oxide. The RDA for zinc is approximately 15 mg. In some embodiments, the composition further comprises 15 mg to 100 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable form of a zinc prodrug. In some embodiments, the composition further comprises 15.0 mg to 100.0 mg, Petition 870260052112, dated 05 / 29 / 2026, p. 42 / 216 35 / 83 such as 40.0 mg to 95.0 mg, 50.0 mg to 90.0 mg, 60.0 mg to 85.0 mg, 70.0 mg to 80.0 mg, or 80.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug. In some embodiments, the composition further comprises 80.0 mg of zinc, optionally in the form of zinc oxide. In some embodiments, the composition further comprises 25.0 mg of zinc, optionally in the form of oxide. In some embodiments, the composition further comprises about 15 mg to about 100 mg of zinc, optionally in the form of zinc oxide, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable form of a zinc prodrug.In some embodiments, the composition further comprises from about 15 mg to about 100 mg, such as about 40 mg to about 95 mg, about 50 mg to about 90 mg, about 60 mg to about 85 mg, about 70 mg to about 80 mg, or about 80 mg, zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug. In some embodiments, the composition also comprises about 80 mg of zinc, optionally in the form of zinc oxide. In some embodiments, the composition further comprises about 25 mg of zinc, optionally in the form of zinc oxide.

[0083] In some embodiments, copper, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above comprises copper oxide. In some embodiments, copper, a prodrug thereof and / or a pharmaceutically acceptable form of any of the above is copper oxide. The RDA for copper is 2.0 mg. In some embodiments, the composition further comprises 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug. Petition 870260052112, dated 05 / 29 / 2026, p. 43 / 216 36 / 83 maco, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug. In some embodiments, the composition further comprises 1.5 mg to 2.0 mg, such as 2.0 mg, of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug. In some embodiments, the composition further comprises 2.0 mg of copper, optionally in the form of copper oxide. In some embodiments, the composition further comprises about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug.In some embodiments, the composition further comprises about 1.5 mg to about 2.0 mg, such as about 2.0 mg, of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug. In some embodiments, the composition further comprises about 2.0 mg of copper, optionally in the form of copper oxide.

[0084] In some embodiments, vitamin B1, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise thiamine. In some embodiments, vitamin B1, prodrugs thereof, and pharmaceutically acceptable salts of any of the above are thiamine. Vitamin B1 is a water-soluble vitamin. The US Recommended Dietary Allowance (RDA) for vitamin B1 taken orally is 1.2 mg for men and 1.1 mg for women over 18 years of age. In some embodiments, the composition further comprises 0.1 mg to 25 mg of vitamin B1 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a prodrug. Petition 870260052112, dated 05 / 29 / 2026, p. 44 / 216 37 / 83 vitamin B1 drug. In some embodiments, the composition further comprises from 0.1 mg to 25.0 mg of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug. In some formulations, the composition also includes 0.1 mg to 25.0 mg, such as 0.5 mg to 20.0 mg, 1.0 mg to 15.0 mg, 1.5 mg to 10.0 mg, 1.1 mg to 4.5 mg, 1.2 mg to 3.5 mg, 1.2 mg to 2.5 mg, 1.2 mg to 1.8 mg, 1.5 mg, 2.0 to 20.0 mg, 2.0 mg to 15.0 mg, 2.5 mg to 10.0 mg, 2.5 mg to 3.5 mg, 2.6 mg to 3.4 mg, 2.8 mg to 3.2 mg, 3 mg, 3.0 mg to 20.0 mg, 3.0 mg to 15.0 mg, 3.0 mg to 10.0 mg, 3.0 mg to 5.0 mg. 3.2 mg to 4.8 mg, 3.4 mg to 4.6 mg, or 4.5 mg of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug. In some embodiments, the composition further comprises 1.5 mg of thiamine.In some embodiments, the composition further comprises 3.0 mg of thiamine. In some embodiments, the composition further comprises 4.5 mg of thiamine. In some embodiments, the composition further comprises from about 0.1 mg to about 25 mg of vitamin B1 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug. In some embodiments, the composition further comprises from about 0.1 mg to about 25 mg of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug.In some embodiments, the composition also comprises from about 0.1 mg to about 25 mg, such as from about 0.5 mg to about 20 mg, from about 1 mg to about 15 mg, from about 1.5 mg to about 10 mg, from about 1.1 mg to about 4.5 mg, from about 1.2 mg to about 3.5 mg, from about 1.2 mg to about 2.5 mg, from about 1.2 mg to about 1.8 mg, from about 1.5 mg, from about 2 to about 20 mg, about. Petition 870260052112, dated 05 / 29 / 2026, page 45 / 216 38 / 83 of 2 mg to about 15 mg, about 2.5 mg to about 10 mg, about 2.5 mg to about 3.5 mg, about 2.6 mg to about 3.4 mg, about 2.8 mg to about 3.2 mg, about 3 mg, about 3 mg to about 20 mg, about 3 mg to about 15 mg, about 3 mg to about 10 mg, about 3 mg to about 5 mg, about 3.2 mg to about 4.8 mg, about 3.4 mg to about 4.6 mg or about 4.5 mg, of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug. In some embodiments, the composition further comprises about 1.5 mg of thiamine. In some formulations, the composition still includes approximately 3 mg of thiamine. In some formulations, the composition still includes approximately 4.5 mg of thiamine.

[0085] In some embodiments, vitamin B2, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise riboflavin. In some embodiments, vitamin B2, prodrugs thereof, and pharmaceutically acceptable salts of any of the above are riboflavin. Vitamin B2 is a water-soluble vitamin. The US Recommended Dietary Allowance (RDA) for vitamin B2 taken orally is 1.1 mg for men and 1.3 mg for women over 18 years of age. In some embodiments, the composition further comprises from 0.1 mg to 25.0 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug.In some formulations, the composition also includes 0.1 mg to 25.0 mg, such as 1.0 mg to 20.0 mg, 1.0 mg to 15.0 mg, 1.0 mg to 10.0 mg, 1.1 mg to 4.5 mg, 1.2 mg to 3.5 mg, 1.2 mg to 2.5 mg, 1.3 mg to 1.8 mg, 1.7 mg, 2.0 mg to 20.0 mg, 2.0 mg to 15.0 mg, 2.0 mg to 10.0 mg, 2.0 mg to 4.0 mg, 2.2 mg to 3.8 mg, 2.6 mg to 3.4 mg, 3.4 mg, 3.0 mg to 20.0 mg, 3.0 mg to 15.0 mg, 3.0 mg to. Petition 870260052112, dated 05 / 29 / 2026, page 46 / 216 39 / 83 10.0 mg, 3.0 mg to 6.0 mg, 3.2 mg to 5.8 mg, 3.4 mg to 5.6 mg or 5.1 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug. In some embodiments, the composition further comprises 1.7 mg of riboflavin. In some embodiments, the composition further comprises 3.4 mg of riboflavin. In some embodiments, the composition further comprises 5.1 mg of riboflavin. In some embodiments, the composition further comprises from about 0.1 mg to about 25 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug.In some embodiments, the composition further comprises from about 0.1 mg to about 25 mg, such as from about 1.0 mg to about 20 mg, from about 1 mg to about 15 mg, from about 1 mg to about 10 mg, from about 1.1 mg to about 4.5 mg, from about 1.2 mg to about 3.5 mg, from about 1.2 mg to about 2.5 mg, from about 1.3 mg to about 1.8 mg, from about 1.7 mg, from about 2 mg to about 20 mg, from about 2 mg to about 15 mg, from about 2 mg to about 10 mg, from about 2 mg to about 4 mg, from about 2.2 mg to about 3.8 mg, from about 2.6 mg to about 3.4 mg, from about 3.4 mg, from about 3 mg to about 20 mg, about 3 mg to about 15 mg, about 3 mg to about 10 mg, about 3 mg to about 6 mg, about 3.2 mg to about 5.8 mg, about 3.4 mg to about 5.6 mg, or about 5.1 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug.In some embodiments, the composition still comprises approximately 1.7 mg of riboflavin. In some embodiments, the composition still comprises approximately 3.4 mg of riboflavin. In some embodiments, the composition still comprises approximately 5.1 mg of riboflavin.

[0086] In some embodiments, vitamin B3, prodrugs of. Petition 870260052112, dated 05 / 29 / 2026, p. 47 / 216 40 / 83 The same and pharmaceutically acceptable salts of any of the above comprise nicotinic acid and / or niacinamide. In some embodiments, vitamin B3, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing are nicotinic acid. Vitamin B3 is a water-soluble vitamin of which there are three chemical forms: nicotinic acid, nicotinamide, and niacinamide. The US Recommended Dietary Allowance (RDA) for vitamin B3 taken orally is 16 mg for men and 14 mg for women over 14 years of age. In some embodiments, the composition further comprises 1.0 mg to 300.0 mg, such as 5.0 mg to 150.0 mg, 10.0 mg to 100.0 mg, 20.0 mg to 60.0 mg, of vitamin B3 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug.In some embodiments, the composition further comprises 18.0 mg to 25.0 mg, such as 18.5 mg to 24.5 mg, 17.0 mg to 24.0 mg, 16.5 mg to 23.5 mg, 16.0 mg to 23.0 mg, or 16.0 mg to 22.0 mg, of vitamin B3 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug. In some embodiments, the composition further comprises 20.0 mg of vitamin B3. In some embodiments, the composition further comprises 40.0 mg of vitamin B3. In some embodiments, the composition further comprises 60.0 mg of vitamin B3. In some embodiments, the composition further comprises from about 1.0 mg to about 300.0 mg, such as from about 5.0 mg to about 150.0 mg, from about 10.0 mg to about 100.0 mg, from about 20.0 mg to about 60.0 mg, of vitamin B3 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug.In some formulations, the composition also comprises approximately 18 mg to approximately 25 mg, as well as approximately 18.5 mg to approximately 25 mg. Petition 870260052112, dated 05 / 29 / 2026, p. 48 / 216 41 / 83 of 24.5 mg, approximately 17 mg to approximately 24 mg, approximately 16.5 mg to approximately 23.5 mg, approximately 16 mg to approximately 23 mg, or approximately 16 mg to approximately 22 mg, of vitamin B3 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug. In some embodiments, the composition further comprises approximately 20 mg of vitamin B3. In some embodiments, the composition further comprises approximately 40 mg of vitamin B3. In some embodiments, the composition also comprises approximately 60 mg of vitamin B3.

[0087] In some embodiments, vitamin B5, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing comprise pantothenic acid. In some embodiments, vitamin B5, prodrugs thereof, and pharmaceutically acceptable salts of any of the foregoing are pantothenic acid. The Recommended Dietary Allowance (RDA) for vitamin B5 is 5 mg for persons over 14 years of age. In some embodiments, the composition further comprises from 1.0 mg to 250.0 mg of pantothenic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug.In some formulations, the composition also includes dosages from 1.0 mg to 250.0 mg, such as 2.0 mg to 200.0 mg, 5.0 mg to 150.0 mg, 5.0 mg to 100.0 mg, 5.0 mg to 50.0 mg, 5.0 mg to 30.0 mg, 4.5 mg to 13.5 mg, 5.0 mg to 12.5 mg, 5.5 mg to 12.0 mg, 6.0 mg to 12.5 mg, 6.5 mg to 12.0 mg, 8.5 mg to 11.0 mg, 9.0 mg to 10.5 mg, or 10.0 mg, 10.0 mg to 25.0 mg, 10.5 mg to 24.5 mg, 12.0 mg to 22.0 mg, 20.0 mg, 20.0 mg 45.0 mg, 25.0 mg to 35.0 mg, 28.0 mg to 32.0 mg, or 30.0 mg of vitamin B5 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug. In some embodiments, a. Petition 870260052112, dated 05 / 29 / 2026, page 49 / 216 42 / 83 composition further comprises 10.0 mg of pantothenic acid. In some embodiments, the composition further comprises 20.0 mg of pantothenic acid. In some embodiments, the composition further comprises 30.0 mg of pantothenic acid. In some embodiments, the composition further comprises from about 1 mg to about 250 mg of pantothenic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug.In some embodiments, the composition further comprises from about 1 mg to about 250 mg, such as from about 2 mg to about 200 mg, from about 5 mg to about 150 mg, from about 5 mg to about 100 mg, from about 5 mg to about 50 mg, from about 5 mg to about 30 mg, from about 4.5 mg to about 13.5 mg, from about 5.0 mg to about 12.5 mg, from about 5.5 mg to about 12 mg, from about 6 mg to about 12.5 mg, from about 6.5 mg to about 12 mg, from about 8.5 mg to about 11.0 mg, from about 9.0 mg to about 10.5 mg, or from about 10 mg, from about 10 mg to about 25 mg, from about 10.5 mg to about 24.5 mg, about 12 mg to about 22 mg, about 20 mg, about 20 mg to about 45 mg, about 25 mg to about 35 mg, about 28 mg to about 32 mg or about 30 mg of vitamin B5 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug.In some formulations, the composition also includes approximately 10 mg of pantothenic acid. In some formulations, the composition also includes approximately 20 mg of pantothenic acid. In some formulations, the composition also includes approximately 30 mg of pantothenic acid.

[0088] In some embodiments, vitamin B6, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items comprise pyridoxine. In some embodiments, vitamin B6, prodrugs thereof, and pharmaceutically acceptable salts of Petition 870260052112, dated 05 / 29 / 2026, p. 50 / 216 43 / 83 any of the above are pyridoxine. The recommended dietary allowance (RDA) for vitamin B6 is 1.3 mg for people aged 14 to 50 years. In some formulations, the composition further comprises 25.0 mg to 100.0 mg of pyridoxine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug. In some embodiments, the composition further comprises 25.0 mg to 200.0 mg of vitamin B6, such as 25.0 mg to 100.0 mg, 30.0 mg to 90.0 mg, 40.0 mg to 80.0 mg, 45.0 mg to 70.0 mg, 45.0 mg to 60.0 mg, 55.0 mg, or 50.0 mg of vitamin B6, or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug. In some embodiments, the composition further comprises 50.0 mg of pyridoxine.In some embodiments, the composition further comprises from about 25 mg to about 100 mg of pyridoxine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug. In some embodiments, the composition further comprises from about 25 mg to about 200 mg of vitamin B6, such as from about 25 mg to about 100 mg, from about 30 mg to about 90 mg, from about 40 mg to about 80 mg, from about 45 mg to about 70 mg, from about 45 mg to about 60 mg, about 55 mg, or about 50 mg of vitamin B6 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt, and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug. In some embodiments, the composition further comprises about 50 mg of pyridoxine.

[0089] In some embodiments, vitamin B7, prodrugs thereof, and pharmaceutically acceptable salts of any of the above comprise biotin. In some embodiments, vitamin B7, Petition 870260052112, dated 05 / 29 / 2026, p. 51 / 216 44 / 83 prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing is biotin. The Recommended Dietary Allowance (RDA) for vitamin B7 is 0.03 mg for persons over 18 years of age. In some embodiments, the composition further comprises 0.01 mg to 1.0 mg of biotin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt thereof and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug. In some embodiments, the composition further comprises 0.01 mg to 1.0 mg, such as 0.01 mg to 0.75 mg, 0.02 mg to 0.75 mg, 0.02 mg to 0.05 mg, 0.02 mg to 0.04 mg or 0.03 mg of vitamin B7 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug. In some embodiments, the composition further comprises 0.03 mg of biotin. In some embodiments, the composition further comprises 0.06 mg of biotin.In some embodiments, the composition further comprises 0.09 mg of biotin. In some embodiments, the composition further comprises from about 0.01 mg to about 1 mg of biotin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug. In some embodiments, the composition further comprises from about 0.01 mg to about 1 mg, such as from about 0.01 mg to about 0.75 mg, from about 0.02 mg to about 0.75 mg, from about 0.02 mg to about 0.05 mg, from about 0.02 mg to about 0.04 mg or about 0.03 mg of vitamin B7 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug. In some formulations, the composition still includes approximately 0.03 mg of biotin. In some formulations, the composition still includes approximately 0.06 mg of biotin.In some formulations, the composition also includes approximately 0.09 mg of biotin. Petition 870260052112, dated 05 / 29 / 2026, p. 52 / 216 45 / 83

[0090] In some embodiments, vitamin B9, a prodrug thereof and / or a pharmaceutically acceptable salt of any vitamin B9 comprises folic acid. In some embodiments, vitamin B9, a prodrug thereof and / or a pharmaceutically acceptable salt of any vitamin B9 comprises folate. In some embodiments, vitamin B9, a prodrug thereof and / or a pharmaceutically acceptable salt of any vitamin B9 comprises methyl tetrahydrofolate. In some embodiments, vitamin B9, a prodrug thereof and / or a pharmaceutically acceptable salt of any vitamin B9 comprises folic acid, folate and / or methyl tetrahydrofolate. The recommended dietary allowance (RDA) for vitamin B9 is 0.4 mg for people over 19 years of age.In some embodiments, the composition further comprises 0.1 mg to 50.0 mg of folic acid, folate and / or methyl tetrahydrofolate or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug. In some embodiments, the composition comprises 1.0 mg to 3.0 mg of folate, folic acid and / or methyl tetrahydrofolate or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug.In some embodiments, the composition further comprises 1.0 mg to 3.0 mg, such as 1.1 mg to 2.9 mg, 1.2 mg to 2.8 mg, 1.3 mg to 2.7 mg, 1.4 mg to 2.6 mg, 1.5 mg to 2.6 mg, 1.6 mg to 2.6 mg, 1.7 mg to 2.6 mg, 1.8 mg to 2.6 mg, 1.9 mg to 2.6 mg, 2.0 mg to 2.6 mg, 2.1 mg to 2.6 mg or 2.5 mg of vitamin B9 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug. In some embodiments, the composition further comprises 2.5 mg of folic acid and / or methyl tetrahydrofolate. In some formulations, the composition also includes approximately 0.1 mg to approximately 50 mg of folic acid and / or methyl tetrahydrofolate, an amount. Petition 870260052112, dated 05 / 29 / 2026, page 53 / 216 46 / 83 equivalent of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug. In some embodiments, the composition further comprises about 1 mg to about 3 mg of folate, folic acid and / or methyl tetrahydrofolate or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug.In some embodiments, the composition still comprises about 1 mg to about 3 mg, such as about 1.1 mg to about 2.9 mg, about 1.2 mg to about 2.8 mg, about 1.3 mg to about 2.7 mg, about 1.4 mg to about 2.6 mg, about 1.5 mg to about 2.6 mg, about 1.6 mg to about 2.6 mg, about 1.7 mg to about 2.6 mg, about 1.8 mg to about 2.6 mg, about 1.9 mg to about 2.6 mg, about 2 mg to about 2.6 mg, about 2.1 mg to about 2.6 mg or about 2.5 mg of vitamin B9 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug. In some formulations, the composition also includes approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate.

[0091] The composition also includes vitamin B12. The recommended dietary allowance (RDA) for vitamin B12 is 2.4 micrograms (0.0024 mg) for people over 14 years of age. In some embodiments, vitamin B12, a prodrug thereof and / or a pharmaceutically acceptable salt of vitamin B12 is cyanocobalamin. In some embodiments, the composition also includes 0.25 mg to 3 mg of vitamin B12 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug. In some embodiments, the composition also includes 0.5 mg to 1.5 mg of vitamin B12 or Petition 870260052112, dated 05 / 29 / 2026, page 54 / 216 47 / 83 an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug. In some embodiments, the composition further comprises 1 mg of vitamin B12. In some embodiments, the composition further comprises about 0.25 mg to about 3 mg of vitamin B12 or an amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug. In some embodiments, the composition further comprises about 0.5 mg to about 1.5 mg of vitamin B12 or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug. In some embodiments, the composition further comprises about 1 mg of vitamin B12.

[0092] In some embodiments, the composition further comprises lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein. In some embodiments, lutein, a prodrug thereof and / or a pharmaceutically acceptable salt of lutein is R',R'-lutein. Lutein is a carotenoid. In some embodiments, the composition further comprises 1 mg to 50 mg, such as 5.0 mg to 15.0 mg, of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.In some embodiments, the composition further comprises at least 3.0 mg, such as 3.0 mg to 50.0 mg, 5.0 mg to 50.0 mg, 6.0 mg to 40.0 mg, 7.0 mg to 30.0 mg, 8.0 mg to 20.0 mg, 9.0 mg to 11.0 mg, 20.0 mg to 30.0 mg, 30.0 mg to 40.0 mg, 40.0 mg to 50.0 mg, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg or 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug. In some embodiments, the composition further comprises... Petition 870260052112, dated 05 / 29 / 2026, page 55 / 216 48 / 83 10.0 mg of lutein. In some embodiments, the composition further comprises approximately 5 mg to approximately 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.In some embodiments, the composition further comprises approximately 1 mg to approximately 50 mg, such as approximately 3 mg to approximately 50 mg, approximately 5 mg to approximately 50 mg, approximately 6 mg to approximately 40 mg, approximately 7 mg to approximately 30 mg, approximately 8 mg to approximately 20 mg, approximately 5 mg to approximately 15 mg, such as approximately 6 mg to approximately 14 mg, approximately 7 mg to approximately 13 mg, approximately 8 mg to approximately 12 mg, approximately 9.0 mg to approximately 11 mg or approximately 10 mg, approximately 9 mg to approximately 11 mg, approximately 20 mg to approximately 30 mg, approximately 30 mg to approximately 40 mg, approximately 40 mg to approximately 50 mg, approximately 10 mg, approximately 20 mg, approximately 30 mg, approximately 40 mg or approximately 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug. In some embodiments, the composition further comprises approximately 10 mg of lutein.

[0093] In some embodiments, the composition further comprises zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin. In some embodiments, the zeaxanthin, a prodrug thereof and / or a pharmaceutically acceptable salt of zeaxanthin is R',R'-zeaxanthin. Zeaxanthin is a carotenoid. In some embodiments, the composition further comprises 1.0 mg to 20.0 mg 1.5 mg to 2.5 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some formulations, the composition also includes 1.0 mg to 20.0 mg, such as 1.0 mg to 3.0 mg, 3.0 mg to 5.0 mg, 5.0 mg to 7.0 mg, 7.0 mg to 9.0 mg, 9.0 mg to 11.0 mg, 11.0 mg to 13.0 mg, 13.0 mg to 15.0 mg, 15.0 mg to Petition 870260052112, dated 05 / 29 / 2026, p. 56 / 216 49 / 83 17.0 mg, 17.0 mg to 19.0 mg, 2.0 mg, 3.0 mg, 4.0 mg, 5.0 mg, 10.0 mg or 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the composition further comprises 2.0 mg of zeaxanthin. In some embodiments, the composition further comprises about 1 mg to about 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.In some embodiments, the composition further comprises 1 mg to about 20 mg, such as about 1 mg to about 3 mg, about 3 mg to about 5 mg, about 5 mg to about 7 mg, about 7 mg to about 9 mg, about 9 mg to about 11 mg, about 11 mg to about 13 mg, about 13 mg to about 15 mg, about 15 mg to about 17 mg, about 17 mg to about 19 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 10 mg or about 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug. In some embodiments, the composition further comprises about 2 mg of zeaxanthin.

[0094] In some embodiments, the composition further comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 50.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; Petition 870260052112, dated 05 / 29 / 2026, page 57 / 216 50 / 83 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug; 0.1 mg to 25 mg of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B1 prodrug; 0.1 mg to 25 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug; 1.0 mg to 300.0 mg of nicotinic acid and / or niacinamide or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug; 1.0 mg to 250.0 mg of pantothenic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug; 25.0 mg to 200.0 mg of pyridoxine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug; 0.01 mg to 1.0 mg of biotin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug; 0.1 mg to 50 mg of folic acid and / or methyl tetrahydrofolate or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug; and 0.25 mg to 3.0 mg of cyanocobalamin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug.

[0095] In some modalities, the compositions comprise Petition 870260052112, dated 05 / 29 / 2026, page 58 / 216 51 / 83 still 5.0 mg to 50.0 mg, such as 5.0 mg to 15.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or 1.0 mg to 2.5 mg, such as 1.5 mg to 2.5 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[0096] In some forms, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 1.5 mg of thiamine; 1.7 mg of riboflavin; 20.0 mg of nicotinic acid and / or niacinamide; 10.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.03 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[0097] In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[0098] In some forms, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 3.0 mg of thiamine; Petition 870260052112, dated 05 / 29 / 2026, page 59 / 216 52 / 83 3.4 mg of riboflavin; 40.0 mg of nicotinic acid and / or niacinamide; 20.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.06 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[0099] In some embodiments, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00100] In some formulations, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 4.5 mg of thiamine; 5.1 mg of riboflavin; 60.0 mg of nicotinic acid and / or niacinamide; 30.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.09 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[00101] In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00102] In some formulations, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 25.0 mg of zinc, optionally in the form of zinc oxide; Petition 870260052112, dated 05 / 29 / 2026, page 60 / 216 53 / 83 2.0 mg of copper, optionally in the form of copper oxide; 1.5 mg of thiamine; 1.7 mg of riboflavin; 20.0 mg of nicotinic acid and / or niacinamide; 10.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.03 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[00103] In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00104] In some formulations, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha-tocopheryl acetate; 25.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 3.0 mg of thiamine; 3.4 mg of riboflavin; 40.0 mg of nicotinic acid and / or niacinamide; 20.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.06 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[00105] In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00106] In some formulations, the composition also includes: 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha acetate. Petition 870260052112, dated 05 / 29 / 2026, page 61 / 216 54 / 83 tocopheryl; 25.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper; 4.5 mg of thiamine; 5.1 mg of riboflavin; 60.0 mg of nicotinic acid and / or niacinamide; 30.0 mg of pantothenic acid; 50.0 mg of pyridoxine; 0.09 mg of biotin; 2.5 mg of folic acid and / or methyl tetrahydrofolate; and 1.0 mg of cyanocobalamin.

[00107] In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00108] In some embodiments, the composition further comprises approximately 350 mg to approximately 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; approximately 50 mg to approximately 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; approximately 20 mg to approximately 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; approximately 1.5 mg to approximately 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug; approximately 0.1 mg to approximately 25 mg of thiamine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or Petition 870260052112, dated 05 / 29 / 2026, page 62 / 216 55 / 83 a pharmaceutically acceptable salt of a vitamin B1 prodrug; about 0.1 mg to about 25 mg of riboflavin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B2 prodrug; approximately 1 mg to approximately 300 mg of nicotinic acid and / or niacinamide or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B3 prodrug; approximately 1 mg to approximately 250 mg of pantothenic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B5 prodrug; approximately 25 mg to approximately 200 mg of pyridoxine or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B6 prodrug; approximately 0.01 mg to approximately 1 mg of biotin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B7 prodrug; approximately 0.1 mg to approximately 50 mg of folic acid and / or methyl tetrahydrofolate or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B9 prodrug; and approximately 0.25 mg to approximately 3 mg of cyanocobalamin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin B12 prodrug.

[00109] In some embodiments, the compositions still comprise from about 5 mg to about 50 mg, such as from about 5 mg to about Petition 870260052112, dated 05 / 29 / 2026, p. 63 / 216 56 / 83 of 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or about 1 mg to about 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[00110] In some forms, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; approximately 1.5 mg of thiamine; about 1.7 mg of riboflavin; approximately 20 mg of nicotinic acid and / or niacinamide; approximately 10 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.03 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00111] In some embodiments, the composition also includes approximately 10 mg of R',R' lutein and / or approximately 2 mg of R',R' zeaxanthin.

[00112] In some embodiments, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; Petition 870260052112, dated 05 / 29 / 2026, p. 64 / 216 57 / 83 about 3 mg of thiamine; about 3.4 mg of riboflavin; approximately 40 mg of nicotinic acid and / or niacinamide; approximately 20 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.06 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00113] In some embodiments, the composition also includes approximately 10 mg of R',R' lutein and / or approximately 2 mg of R',R' zeaxanthin.

[00114] In some embodiments, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; approximately 4.5 mg of thiamine; about 5.1 mg of riboflavin; approximately 60 mg of nicotinic acid and / or niacinamide; approximately 30 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.09 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00115] In some embodiments, the composition also includes approximately 10 mg of R',R' lutein and / or approximately 2 mg of R',R' zeaxanthin.

[00116] In some embodiments, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; Petition 870260052112, dated 05 / 29 / 2026, p. 65 / 216 58 / 83 approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 1.5 mg of thiamine; about 1.7 mg of riboflavin; approximately 20 mg of nicotinic acid and / or niacinamide; approximately 10 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.03 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00117] In some embodiments, the composition also includes approximately 10 mg of R',R' lutein and / or approximately 2 mg of R',R' zeaxanthin.

[00118] In some embodiments, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 3 mg of thiamine; about 3.4 mg of riboflavin; approximately 40 mg of nicotinic acid and / or niacinamide; approximately 20 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.06 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00119] In some modalities, the composition also includes Petition 870260052112, dated 05 / 29 / 2026, p. 66 / 216 59 / 83 approximately 10 mg of R',R' lutein and / or approximately 2 mg of R',R' zeaxanthin.

[00120] In some embodiments, the composition also includes: approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 25 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 4.5 mg of thiamine; about 5.1 mg of riboflavin; approximately 60 mg of nicotinic acid and / or niacinamide; approximately 30 mg of pantothenic acid; approximately 50 mg of pyridoxine; approximately 0.09 mg of biotin; approximately 2.5 mg of folic acid and / or methyl tetrahydrofolate; and approximately 1 mg of cyanocobalamin.

[00121] In some embodiments, the composition further comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[00122] In some embodiments, the composition further comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 50.0 mg to 550.0 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a prodrug. Petition 870260052112, dated 05 / 29 / 2026, page 67 / 216 60 / 83 of copper; 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or 1.5 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[00123] In some embodiments, the composition further comprises about 350 mg to about 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; about 50 mg to about 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; about 20 mg to about 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; about 1.5 mg to about 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug;approximately 5 mg to approximately 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug; and / or approximately 1 mg to approximately 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

[00124] In some embodiments, the composition comprises 350.0 mg to 800.0 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 50.0 mg to 550.0 mg of vitamin E or an equivalent amount of Petition 870260052112, dated 05 / 29 / 2026, page 68 / 216 61 / 83 a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; 20.0 mg to 90.0 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug; 150.0 mg to 250.0 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; 35.0 mg to 45.0 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; and 35.0 mg to 45.0 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid. In some embodiments, the compositions further comprise 5.0 mg to 50.0 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of lutein; and / or 1.0 mg to 20.0 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin.

[00125] In some modalities, the composition comprises 40.0 mg of at least one C26+ (5n-3) acid; 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha acetate. Petition 870260052112, dated 05 / 29 / 2026, page 69 / 216 62 / 83 tocopheryl; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid.

[00126] In some modalities, the composition comprises 40.0 mg of at least one C26+ (5n-3) acid; 500.0 mg of vitamin C, optionally in the form of ascorbic acid; 180.0 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; 80.0 mg of zinc, optionally in the form of zinc oxide; 2.0 mg of copper, optionally in the form of copper oxide; optionally from 1.0 mg to 200.0 mg of C32 (6n-3) acid; 200.0 mg of docosahexaenoic acid; and 40.0 mg of eicosapentaenoic acid. In some formulations, the composition also includes 10.0 mg of R',R' lutein and / or 2.0 mg of R',R' zeaxanthin.

[00127] In some embodiments, the composition comprises from about 0.5 mg to about 25 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; approximately 350 mg to approximately 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug; approximately 50 mg to approximately 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug; Petition 870260052112, dated 05 / 29 / 2026, page 70 / 216 63 / 83 approximately 20 mg to approximately 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug; approximately 1.5 mg to approximately 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug; approximately 150 mg to approximately 250 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; In some embodiments, the compositions further comprise about 35 mg to about 45 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid; and in some embodiments, the compositions further comprise about 5 mg to about 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of lutein; and / or about 1 mg to about 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of zeaxanthin.

[00128] In some modalities, the composition comprises 0.5 mg to 50 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; 250 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a vitamin C prodrug; mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt Petition 870260052112, dated 05 / 29 / 2026, page 71 / 216 64 / 83 acceptable level of a vitamin E prodrug; mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zinc prodrug; mg of copper or an equivalent amount of a prodrug, pharmaceutically acceptable salts and / or a pharmaceutically acceptable salt of a copper prodrug; mg of lutein, its prodrug, and pharmaceutically acceptable salts according to any of the above; and mg of zeaxanthin, its prodrug, and pharmaceutically acceptable salts according to any of the above.

[00129] In some modalities, the composition comprises 0.5 mg to 50 mg of at least one C26+ (5n-3) acid or an equivalent amount of prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid prodrugs; 500 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a vitamin C prodrug; 180 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a vitamin E prodrug; mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zinc prodrug; mg of copper or an equivalent amount of a prodrug, pharmaceutically acceptable salts and / or a pharmaceutically acceptable salt of a copper prodrug; mg of lutein, prodrugs thereof, and pharmaceutically acceptable salts according to any of the foregoing; and Petition 870260052112, dated 05 / 29 / 2026, page 72 / 216 65 / 83 mg of zeaxanthin, prodrugs thereof, and pharmaceutically acceptable salts according to any of the above.

[00130] In some forms, the composition comprises approximately 500 mg of vitamin C, optionally in the form of ascorbic acid; approximately 180 mg of vitamin E, optionally in the form of dl-alpha tocopheryl acetate; about 80 mg of zinc, optionally in the form of zinc oxide; about 2 mg of copper, optionally in the form of copper oxide; about 200 mg of docosahexaenoic acid; about 40 mg of hair minus a C26+ acid (5n-3); e about 40 mg of eicosapentaenoic acid.

[00131] In some embodiments, the composition further comprises about 10 mg of R',R' lutein and / or about 2 mg of R',R' zeaxanthin.

[00132] The compositions disclosed in this document may be prepared according to any known method for the manufacture of dietary supplements or pharmaceutical preparations. As will be appreciated by those skilled in the art, various methods are known. For information on materials, equipment, and processes for preparing formulations and dosage forms, see Pharmaceutical Dosage Form Tablets, eds. Liberman et al. (New York, Marcel Dekker, Inc., 1989), Remington—The Science and Practice of Pharmacy, 20th ed., Lippincott Williams & Wilkins, Baltimore, Md., 2000, and Pharmaceutical Dosage Forms and Drug Delivery Systems, 6th Edition, Ansel et al. al., (Media, Pa.: Williams and Wilkins, 1995) which provide information on carriers, materials, equipment, and processes for preparing formulations.

[00133] A method of manufacturing the compositions disclosed in this document may comprise combining the vitamins mentioned, as well as any desired excipients, and mechanical mixing, Petition 870260052112, dated 05 / 29 / 2026, page 73 / 216 66 / 83 such as, for example, using a mixer to form a mixture. If necessary, the mixture can then be tumbled until uniform. The mixture can then be compressed using a tablet press to form tablets. Optionally, a coating can be sprayed onto the tablets and the tablets are tumbled until dry. Alternatively, the mixture can be placed in medium-chain triglycerides to form a fluid paste for containment in a soft gel capsule, the mixture can be placed in a gelatin capsule, or the mixture can be placed in other dosage forms known to those skilled in the art.

[00134] Methods for treating and / or preventing at least one disease, disorder and / or condition associated with a loss of visual acuity, including, for example, age-related macular degeneration (AMD), are disclosed in this document, the methods comprising administering to an individual a composition disclosed in this document.

[00135] At least one disease, disorder, and / or condition associated with a loss of visual acuity includes age-related macular degeneration (AMD). In some modalities, the method disclosed in this document is effective in preventing, attenuating, or inhibiting the progression of AMD. In some modalities, AMD is either wet AMD or dry AMD.

[00136] In some modalities, at least one disease, disorder and / or condition associated with a loss of visual acuity is chosen from among macular degeneration, age-related macular degeneration (AMD), retinal pigment epithelium atrophy (RPE), atrophy of at least one photoreceptor, drusen, epithelial drusenoid pigment detachment (EDP), diabetic retinopathy, cataract, retinitis pigmentosa, glaucoma, choroidal neovascularization, retinal degeneration, Stargardts disease and oxygen-induced retinopathy. Petition 870260052112, dated 05 / 29 / 2026, p. 74 / 216 67 / 83

[00137] In some embodiments of the methods disclosed in this document, the compositions disclosed in this document are administered to an individual in one, two, three, or four daily doses. In some embodiments, the compositions are administered, each in the form of one, two, three, or four dosage units, one, two, three, or four times a day, such as in the form of two tablets taken twice a day or in the form of one tablet taken twice a day.

[00138] Methods for drusen regression and / or epithelial detachment of drusenoid pigment (EDP) are also disclosed in this document, comprising administering to an individual a composition disclosed in this document. Methods for treating and / or preventing retinal pigment epithelium (RPE) atrophy and / or at least one photoreceptor atrophy are disclosed in this document, wherein the methods comprise administering to an individual a composition disclosed in this document. Methods for treating and / or preventing vision loss and / or improving visual acuity are also disclosed in this document.

[00139] In some embodiments, administration of a composition as described in this document causes a complete disappearance (i.e., 100% regression) of the drusen. In some embodiments, administration of a composition as described in this document prevents atrophy of the RPE and / or photoreceptors in a patient (i.e., geographic atrophy).

[00140] In some embodiments of the disclosed methods, the individuals to whom the compositions are administered are chosen from among individuals suspected of suffering from at least one disease, disorder and / or condition associated with a loss of visual acuity, individuals known to suffer from at least one disease, disorder and / or condition associated with a loss of visual acuity, and individuals at risk of developing at least one disease, disorder and / or condition. Petition 870260052112, dated 05 / 29 / 2026, p. 75 / 216 68 / 83 associated with a loss of visual acuity.

[00141] In some modalities, the disclosed methods also include identifying an individual as being at risk of developing at least one disease, disorder and / or condition associated with a loss of visual acuity. In some modalities, the disclosed methods also include identifying an individual as being at risk of developing AMD. In some modalities, the disclosed methods also include identifying an individual as having AMD. In some modalities, the disclosed methods also include identifying an individual as being at risk of AMD progression.

[00142] In some embodiments of the methods described in this document, the subject is a human. In some embodiments of the methods described in this document, the subject is a non-human animal. Non-human animals include mammals, for example, non-human primates, swine, equines, canines, felines, bovines, rodents, and other domestic, farm, and zoo animals.

[00143] An individual at risk of developing at least one disease, disorder and / or condition associated with a loss of visual acuity may be identified by one or more diagnostic or prognostic assays described in this document and / or known to those skilled in the art.

[00144] In some embodiments, the methods disclosed in this document treat and / or prevent at least one disease, disorder, and / or condition associated with a loss of visual acuity, as evidenced by an improvement in visual acuity. In some embodiments, the methods disclosed in this document further comprise monitoring the individual for the effectiveness of administering to the individual a composition, as disclosed in this document. For example, in Petition 870260052112, dated 05 / 29 / 2026, page 76 / 216 69 / 83 In some modalities, the methods disclosed in this document also include monitoring an individual for visual acuity enhancement, which involves measuring a visual acuity parameter in the individual at a first time point before administration of the composition disclosed in this document, measuring the same parameter in the individual at a second time point after administration of the composition disclosed in this document, and comparing the two measurements to assess the improvement.

[00145] The methods disclosed in this document comprise the administration of a daily dose of a composition disclosed in this document. The determination and adjustment of an appropriate dosage regimen (e.g., adjusting the number of doses and frequency of dosing) per day can be performed by one skilled in the relevant art and will depend on several factors, such as the nature and progression of at least one disease, disorder and / or condition associated with a loss of visual acuity and the health and / or age of the individual.

[00146] In some embodiments, the composition disclosed in this document is formulated in the form of one tablet, two tablets, three tablets, four tablets, etc., and is administered to an individual in a single dose per day, in two doses per day, in three doses per day, in four doses per day, etc., or up to, for example, ten doses per day. In some embodiments, the composition disclosed in this document is formulated in the form of four tablets that are administered to an individual in two doses of two tablets per day. In some embodiments, the composition disclosed in this document is administered to an individual for at least one week, at least two weeks, at least three weeks, at least one month, at least two months, at least three months, at least four months, at least five months, at least six months, at least twelve months, at least one year, or for more than one year. Petition 870260052112, dated 05 / 29 / 2026, p. 77 / 216 70 / 83

[00147] This document also discloses methods for preventing, stabilizing, reversing, and / or treating macular degeneration or visual acuity loss by reducing the risk of developing late- or advanced-stage age-related macular degeneration in individuals with early-onset age-related macular degeneration, comprising providing an individual with a daily dosage of not less than about 1.5 mg of thiamine, about 1.7 mg of riboflavin, about 20 mg of nicotinic acid and / or niacinamide, about 10 mg of pantothenic acid, and about 50 mg of pyridoxine. In some embodiments, the daily dosage is provided in the form of two tablets taken twice daily or in the form of one tablet taken twice daily.

[00148] The effectiveness of the compositions and methods of the present disclosure, for example, in the treatment and / or prevention of at least one disease, disorder and / or condition associated with a loss of visual acuity, can be determined by one skilled in the relevant art. One or any combination of diagnostic methods, including physical examination, symptom assessment and monitoring, and performance of analytical tests and methods described in this document, may be used to monitor at least one disease, disorder and / or condition. For example, eye examinations such as biomicroscopy, tonometry, fundoscopy examinations (e.g., color fundus photography), macular function assessment, optical coherence tomography (OCT), autofluorescence and / or angiography (e.g., fluorescein angiography and OCT-based angiography (OCTA)) may be used.

[00149] For example, visual acuity can be assessed by any suitable method known to one skilled in the art. In some modalities, visual acuity is assessed by determining the smallest letters the patient can read on a standard vision chart at a defined distance. Additionally, for example, progression Petition 870260052112, dated 05 / 29 / 2026, page 78 / 216 71 / 83 of AMD can be assessed by measuring a parameter, such as neovascularization. Maintenance or a reduction in the measured parameter from the first time point to the second time point is indicative of the prevention of AMD progression. In some modalities, the progression or regression of AMD and / or drusen is assessed by determining a specific drusen parameter in a patient at a first time point (e.g., before administration of a high-dose statin), determining the same parameter in the same patient at a second time point (e.g., after administration of a high-dose statin), and comparing the parameter measured at the first time point and the second time point. The drusen parameter may be, for example, volume, height, diameter, and / or number.For example, druse regression can be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99%. In some embodiments, druse is reduced from 5% to at least 40%, such as 90%. Furthermore, atrophy can be assessed, for example, by measuring a parameter such as autofluorescence or retinal thickness, and PED can be assessed for flattening, for example, by measuring a parameter such as volume, height and / or diameter, and can be assessed for new fixation to Bruch's membrane by measuring, for example, a parameter such as separation distance. Example 1: In Vitro Activity of C32 (6n-3) Acid

[00150] Three-month-old wild-type (WT) C57BL / 6J mice (22 ± 3 g) were each fed by gavage 6 mg per day of liposomes with VLCPUFA (0.1 mL) loaded with C32 (6n-3) (32:6 n-3) acid (250 mg / kg body weight) prepared Petition 870260052112, dated 05 / 29 / 2026, page 79 / 216 72 / 83 as reported in Gorusupudi et al. PNAS 118(6), e2017739118 (2021), which is incorporated herein by reference in its entirety. Mice were sacrificed 0, 2, 4, 8, and 24 hours after gavage (n = 4 mice / time interval) to collect blood and other tissues. The eyes were dissected under a microscope to separate the retina from the RPE. One retina / mouse pair was used for lipid extraction, and the blood was centrifuged for 5 minutes at 7,500 rpm to separate the serum from the RBCs. Serum, RBCs, brain, liver, retina, and RPE were used for lipid extractions and GC-MS analysis.

[00151] As shown in FIG. In Figure 1A, the 32:6 n-3 serum became detectable within 2 hours after oral administration and then reached a lower steady-state concentration over the following 24 hours. A significant increase in 32:6 n-3 in the retina and RPE was observed 4 to 8 hours after gavage (FIG 1B).On the other hand, 32:6 n-3 remained undetectable in the liver, brain, and red blood cell membranes (RBCs) for a period of 24 hours. Long-term absorption was studied by gavage feeding of liposomes loaded with VLCPUFA (0.1 mL) to WT (22 ± 3 g) and conditionally KO mice developed with the intention of completely eliminating Elovl4 expression in rods and cones (E4cKO mice) (23 ± 3 g) for 15 days with 0, 1, and 2 mg / d 32:6 n-3 (n = 6 mice / group). Mice were fed every morning with liposomes prepared as described above containing 0 mg / d (0 mg / kg BW), 1 mg / d (40 mg / kg BW), or 2 mg / d (80 mg / kg BW) of 32:6 n-3. The mice were sacrificed at the end of the experiments, and retina, RPE, liver, serum, RBCs, and brain tissues were collected, extracted for lipids, and analyzed by GC-MS.

[00152] As shown in FIG. 2A, C32 (6n3) acid levels increased significantly by more than two-fold in the retina and seven-fold in the RPE in both groups fed 32:6 n-3 in Petition 870260052112, dated 05 / 29 / 2026, page 80 / 216 73 / 83 compared with the 0 mg / d controls. A significant increase (P < 0.05) in total retinal VLCPUFAs was also observed in the 2 mg / d group (0.872 ± 0.10%) compared with the 1 mg / d (0.535 ± 0.06%) and 0 mg / d (0.531 ± 0.16%) groups. Serum and RBC VLCPUFAs remained undetectable in control mice and increased significantly in the 32:6 n-3 fed groups, as shown in Figure 2B. The liver had detectable levels of 32:6 n-3 only in the 2 mg / d group (FIG. 2B), while no VLCPUFAs were detectable in the brain.

[00153] Retina and RPE were extracted for phospholipid analysis using liquid chromatography-tandem MS (LC-MS / MS), and increases in phosphatidylcholine (PC)-22:6 / 32:6 were detected in the retina and RPE in supplemented WT animals (FIGs. 3A and 3B). The levels of 32:6 n-3 retinal and RPE in E4cKO mice were one-third and half the levels in age-matched WT mice, respectively (FIG. 4A). After 15 days of gavage feeding with 2 mg / d of synthetic 32:6 n-3, 8-month-old E4cKO mice had an almost fivefold increase in their retinal 32:6 n-3 levels (P < 0.01) and a 27-fold increase in RPE (P = 0.001) compared to E4cKO mice fed control (FIG. 4A).There was a significant increase (P < 0.05) in total retinal VLCPUFAs in E4cKO mice fed 2 mg / d of 32:6 n-3 (0.088 ± 0.02%) compared with E4cKO mice fed 0 mg / d (0.030 ± 0.01%), which approached the levels in age-matched WT mice fed 0 mg / d (0.102 ± 0.008%). Liver 32:6 n-3 and RBC became detectable in mice fed 2 mg / d of 32:6 n3 compared to undetectable levels in E4cKO and WT mice fed 0 mg / d (FIG 4A).

[00154] These observations support the inventor's belief that compositions comprising at least one fatty acid chain Petition 870260052112, dated 05 / 29 / 2026, p. 81 / 216 74 / 83 very long chain fatty acids selected from C26+ (5n-3) acids, prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing may be used to maintain normal retinal physiology and may also be used to enhance visual acuity. Therefore, the findings support the currently claimed uses of compositions comprising at least one very long chain fatty acid selected from C26+ (5n-3) acids, prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing, including methods of delaying the progression and / or onset of macular degeneration and methods of treating and / or preventing at least one disease, disorder and / or condition associated with a loss of visual acuity. Predictive Examples

[00155] The following compositions may be prepared. The quantities in each composition are established based on daily dosage. Each composition may be formulated in two or more dosage units, wherein the dosage units may be administered to an individual daily. Each active ingredient in each composition may be in the form referred to (e.g., acid), a prodrug thereof and / or a pharmaceutically acceptable salt of said form and / or a prodrug thereof. Active ingredient Quantity (mg) C34 (5n-3) acid 1 10 25 100 500 1000 Active ingredient Quantity (mg) C30 (5n-3) acid 1 10 25 100 500 1000 Active ingredient Quantity (mg) C26 (5n-3) acid 1 10 25 100 500 1000 Petition 870260052112, dated 05 / 29 / 2026, page 82 / 216 75 / 83 Active ingredient Quantity (mg) C34 (5n-3) acid 0.33 3.33 8.33 33.33 166.67 333.33 C30 (5n-3) acid 0.33 3.33 8.33 33.33 166.67 333.33 C26 (5n-3) acid 0.33 3.33 8.33 33.33 166.67 333.33 Active ingredient Quantity (mg) C34 (5n-3) acid 0.5 5 12.5 50 250 500 C30 (5n-3) acid 0.5 5 12.5 50 250 500 Active ingredient Quantity (mg) C34 (5n-3) acid 0.1 1 2.5 10 50 100 C30 (5n-3) acid 0.9 9 22.5 90 450 900 Active ingredient Quantity (mg) C34 (5n-3) acid 0.9 9 22.5 90 450 900 C30 (5n-3) acid 0.1 1 2.5 10 50 100 Active ingredient Quantity (mg) C26-34 (6n3) acid 10.0 24.0 420 120.0 1.2 150.0 200.0 DHA 100.0 150.0 0 120.0 0 100 200.0 C26-34 (5n3) acid 2.0 6.0 84 120.0 1.2 30.0 40.0 EPA 0 100.0 0 120.0 0 20.0 40.0 Active ingredient Quantity (mg) C2634 (5n-3) acid 84 84 84 40.0 40.0 40.0 30.0 30.0 30.0 120.0 120.0 120.0 DHA 0 0 0 200.0 200.0 200.0 100 100 100 120.0 120.0 120.0 EPA 0 0 0 40.0 40.0 40.0 20.0 20.0 20.0 120.0 120.0 120.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 1.5 3.0 4.5 1.5 3.0 4.5 Petition 870260052112, dated 05 / 29 / 2026, p. 83 / 216 76 / 83 Vitamin B2 (Riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20 40 60 20 40 60 20 40 60 20 40 60 Vitamin B5 (pantothenic acid) 10 20 30 10 20 30 10 20 30 10 20 30 Vitamin B6 (Pyridoxine) 50 50 50 50 50 50 50 50 50 50 50 50 Vitamin B7 (Biotin) 0.0 3 0.0 6 0.0 9 0.0 3 0.06 0.09 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 6.0 6.0 6.0 2.0 2.0 2.0 0.4 0.4 0.4 1.2 1.2 1.2 DHA 150.0 150.0 150.0 100.0 100.0 100.0 0 0 0 0 0 0 EPA 100.0 100.0 100.0 0 0 0 0 0 0 0 0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 1.7 3.4 5.1 1.7 3.4 5.1 Petition 870260052112, dated 05 / 29 / 2026, page 84 / 216 77 / 83 Vitamin B3 (nicotinic acid and / or niacinamide) 20 40 60 20 40 60 20 40 60 20 40 60 Vitamin B5 (pantothenic acid) 10 20 30 10 20 30 10 20 30 10 20 30 Vitamin B6 (Pyridoxine) 50 50 50 50 50 50 50 50 50 50 50 50 Vitamin B7 0.0 0.06 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 (Biotin) 3 9 3 6 9 3 6 9 3 6 9 Vitamin B9 (folic acid and / or tetrahydrofolate) Methyl(II) 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 84 84 84 84 84 84 DHA 0 0 0 0 0 0 EPA 0 0 0 0 0 0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 25.0 80.0 25.0 80.0 25.0 80.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 3.0 3.0 1.5 1.5 4.5 4.5 Petition 870260052112, dated 05 / 29 / 2026, page 85 / 216 78 / 83 Vitamin B2 (Riboflavin) 3.4 3.4 1.7 1.7 5.1 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 40.0 40.0 20.0 20.0 60.0 60.0 Vitamin B5 (pantothenic acid) 20.0 20.0 10.0 10.0 30.0 30.0 Vitamin B6 (Pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.06 0.06 0.03 0.03 0.09 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 40.0 40.0 40.0 40.0 40.0 40.0 DHA 200.0 200.0 200.0 200.0 200.0 200.0 EPA 40.0 40.0 40.0 40.0 40.0 40.0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 25.0 80.0 25.0 80.0 25.0 80.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 3.0 4.5 4.5 1.5 Vitamin B2 (riboflavin) 1.7 3.4 3.4 5.1 5.1 1.7 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 40.0 60.0 60.0 20.0 Vitamin B5 (pantothenic acid) 10.0 20.0 20.0 30.0 30.0 10.0 Vitamin B6 (Pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.03 0.06 0.06 0.09 0.09 0.03 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) Petition 870260052112, dated 05 / 29 / 2026, page 86 / 216 79 / 83 C26-34 (5n-3) Acid 40.0 40.0 40.0 40.0 40.0 40.0 C26+ (6n-3) Acid 10.0 10.0 10.0 10.0 10.0 10.0 DHA 200.0 200.0 200.0 200.0 200.0 200.0 EPA 40.0 40.0 40.0 40.0 40.0 40.0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 25.0 80.0 25.0 80.0 25.0 80.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 3.0 4.5 4.5 1.5 Vitamin B2 (riboflavin) 1.7 3.4 3.4 5.1 5.1 1.7 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 40.0 60.0 60.0 20.0 Vitamin B5 (pantothenic acid) 10.0 20.0 20.0 30.0 30.0 10.0 Vitamin B6 (pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (biotin) 0.03 0.06 0.06 0.09 0.09 0.03 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0, Active ingredient Quantity (mg) C26-34 (5n-3) acid 30.0 30.0 30.0 30.0 30.0 30.0 DHA 100 100 100 100 100 100 EPA 20.0 20.0 20.0 20.0 20.0 20.0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 25.0 80.0 25.0 80.0 25.0 Petition 870260052112, dated 05 / 29 / 2026, page 87 / 216 80 / 83 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 4.5 3.0 3.0 1.5 1.5 4.5 Vitamin B2 (riboflavin) 5.1 3.4 3.4 1.7 1.7 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 60.0 40.0 40.0 20.0 20.0 60.0 Vitamin B5 (pantothenic acid) 30.0 20.0 20.0 10.0 10.0 30.0 Vitamin B6 (Pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.09 0.06 0.06 0.03 0.03 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 120.0 120.0 120.0 120.0 120.0 120.0 DHA 120.0 120.0 120.0 120.0 120.0 120.0 EPA 120.0 120.0 120.0 120.0 120.0 120.0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 80.0 80.0 25.0 25.0 25.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 60.0 20.0 40.0 60.0 Vitamin B5 (pantothenic acid) 10.0 20.0 30.0 10.0 20.0 30.0 Vitamin B6 (pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Petition 870260052112, dated 05 / 29 / 2026, pp. 88 / 216 81 / 83 Active ingredient Quantity (mg) Vitamin B7 (Biotin) 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 6.0 6.0 6.0 6.0 6.0 6.0 DHA 150.0 150.0 150.0 150.0 150.0 150.0 EPA 100.0 100.0 100.0 100.0 100.0 100.0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 80.0 80.0 25.0 25.0 25.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 60.0 20.0 40.0 60.0 Vitamin B5 (pantothenic acid) 10.0 20.0 30.0 10.0 20.0 30.0 Vitamin B6 (Pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 2.0 2.0 2.0 2.0 2.0 2.0 DHA 100.0 100.0 100.0 100.0 100.0 100.0 EPA 0 0 0 0 0 0 Petition 870260052112, dated 05 / 29 / 2026, p. 89 / 216 82 / 83 Active ingredient Quantity (mg) Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 80.0 80.0 25.0 25.0 25.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 60.0 20.0 40.0 60.0 Vitamin B5 (pantothenic acid) 10.0 20.0 30.0 10.0 20.0 30.0 Vitamin B6 (pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (biotin) 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (Folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 0.4 0.4 0.4 0.4 0.4 0.4 DHA 0 0 0 0 0 0 EPA 0 0 0 0 0 0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 80.0 80.0 25.0 25.0 25.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Petition 870260052112, dated 05 / 29 / 2026, pp. 90 / 216 83 / 83 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (Riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 60.0 20.0 40.0 60.0 Vitamin B5 (pantothenic acid) 10.0 20.0 30.0 10.0 20.0 30.0 Vitamin B6 (Pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Active ingredient Quantity (mg) C26-34 (5n-3) acid 1.2 1.2 1.2 1.2 1.2 1.2 DHA 0 0 0 0 0 0 EPA 0 0 0 0 0 0 Vitamin C (ascorbic acid or equivalent) 500.0 500.0 500.0 500.0 500.0 500.0 Vitamin E (alpha tocopherol or equivalent) 180.0 180.0 180.0 180.0 180.0 180.0 Zinc (zinc oxide or equivalent) 80.0 80.0 80.0 25.0 25.0 25.0 Copper (copper oxide or equivalent) 2.0 2.0 2.0 2.0 2.0 2.0 Lutein (R'R') 10.0 10.0 10.0 10.0 10.0 10.0 Zeaxanthin (R'R') 2.0 2.0 2.0 2.0 2.0 2.0 Vitamin B1 (thiamine) 1.5 3.0 4.5 1.5 3.0 4.5 Vitamin B2 (riboflavin) 1.7 3.4 5.1 1.7 3.4 5.1 Vitamin B3 (nicotinic acid and / or niacinamide) 20.0 40.0 60.0 20.0 40.0 60.0 Vitamin B5 (pantothenic acid) 10.0 20.0 30.0 10.0 20.0 30.0 Vitamin B6 (pyridoxine) 50.0 50.0 50.0 50.0 50.0 50.0 Vitamin B7 (Biotin) 0.03 0.06 0.09 0.03 0.06 0.09 Vitamin B9 (folic acid and / or methyl tetrahydrofolate) 2.5 2.5 2.5 2.5 2.5 2.5 Vitamin B12 (Cyanocobalamin) 1.0 1.0 1.0 1.0 1.0 1.0 Petition 870260052112, dated 05 / 29 / 2026, pp. 91 / 216

Claims

1 / 9 CLAIMS 1. Composition for visual health, characterized in that it comprises at least one very long-chain fatty acid selected from C26+ (5n-3) acids, prodrugs thereof and pharmaceutically acceptable salts of any of the foregoing.

2. Composition according to claim 1, characterized in that the composition comprises 1 mg to 1000 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids.

3. Composition according to claim 1, characterized in that the composition comprises 10 mg to 500 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids.

4. Composition according to claim 1, characterized in that the composition comprises 25 mg to 100 mg of at least one very long-chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid selected from C26+ (5n-3) acids.

5. Composition, according to any one of claims 1 to 4, characterized in that the composition comprises 40 mg of at least one very long chain fatty acid selected from C26+ (5n-3) acids or an equivalent amount of Petition 870260052112, dated 05 / 29 / 2026, page 92 / 216 2 / 9 prodrugs, pharmaceutically acceptable salts and / or pharmaceutically acceptable salts of C26+ (5n-3) acid groups prodrugs.

6. Composition according to any one of claims 1 to 5, characterized in that the C26+ (5n-3) acids are a C26 (5n-3) acid, a C28 (5n-3) acid, a C30 (5n-3) acid, a C32 (5n-3) acid and / or a C34 (5n-3) acid.

7. Composition, according to any one of claims 1 to 6, characterized in that it further comprises at least one additional component chosen from: at least one very long-chain fatty acid chosen from C26+ (6n-3) acids, prodrugs thereof, pharmaceutically acceptable salts thereof and a pharmaceutically acceptable salt of a prodrug of at least one very long-chain fatty acid chosen from C26+ (6n-3) acids.docosahexaenoic acid, prodrugs thereof and / or pharmaceutically acceptable salts of any of the above items; eicosapentaenoic acid, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above; vitamin C, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above; vitamin E, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above; zinc, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above items; copper, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above items; lutein, prodrugs thereof and / or pharmaceutically acceptable salts according to any of the above; and Petition 870260052112, dated 05 / 29 / 2026, p. 93 / 216 3 / 9 zeaxanthin, prodrugs thereof and / or pharmaceutically acceptable salts in accordance with any of the above items.

8. Composition, according to any one of claims 1 to 7, characterized in that it further comprises 20 mg to 350 mg of docosahexaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of docosahexaenoic acid.

9. Composition, according to any one of claims 1 to 8, characterized in that it further comprises 20 mg to 650 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid.

10. Composition, according to any one of claims 1 to 9, characterized in that it further comprises 350 mg to 800 mg of vitamin C or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin C prodrug.

11. Composition, according to any one of claims 1 to 10, characterized in that it further comprises 50 mg to 550 mg of vitamin E or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a vitamin E prodrug.

12. Composition, according to any one of claims 1 to 11, characterized in that it further comprises 20 mg to 90 mg of zinc or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a zinc prodrug. Petition 870260052112, dated 05 / 29 / 2026, p. 94 / 216 4 / 9 13. Composition, according to any one of claims 1 to 12, characterized in that it further comprises 1.5 mg to 2.5 mg of copper or an equivalent amount of a prodrug, a pharmaceutically acceptable form and / or a pharmaceutically acceptable salt of a copper prodrug.

14. Composition, according to any one of claims 1 to 13, characterized in that it further comprises 5 mg to 50 mg of lutein or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a lutein prodrug.

15. Composition, according to any one of claims 1 to 14, characterized in that it comprises 1 mg to 20 mg of zeaxanthin or an equivalent amount of a prodrug, a pharmaceutically acceptable salt and / or a pharmaceutically acceptable salt of a zeaxanthin prodrug.

16. Composition according to claim 1, characterized in that it comprises: optionally 1 mg to 200 mg of at least one C26+ (6n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one C26+ (6n-3) acid; 40 mg of at least one C26+ (5n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one C26+ (5n-3) acid; 200 mg of docosahexaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of docosahexaenoic acid; and 40 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid. Petition 870260052112, dated 29 / 05 / 2026, page 95 / 216 5 / 9 17. Composition according to claim 1, characterized in that it comprises: optionally 1 mg to 200 mg of C26+ (6n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a C26+ (6n-3) acid prodrug; 40 mg of at least one C26-34 (5n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one C26-34 (5n-3) acid; 200 mg of docosahexaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; and 40 mg of eicosapentaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of eicosapentaenoic acid.

18. Composition according to claim 1, characterized in that it comprises: 500.0 mg of vitamin C or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a vitamin C prodrug; 180.0 mg of vitamin E or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a vitamin E prodrug; 80.0 mg of zinc or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a zinc prodrug; 2.0 mg of copper or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a zinc prodrug; up to 200.0 mg of at least one C26+ (6n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a prodrug of at least one C26+ (6n-3) acid;200.0 mg of docosahexaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; 40.0 mg of at least one C26+ (5n-3) acid; and 40.0 mg of eicosapentanoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of an eicosapentanoic acid prodrug.

19. Composition according to claim 1, characterized in that it comprises: 500.0 mg of vitamin C or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a vitamin C prodrug; 180.0 mg of vitamin E or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of vitamin E; 80.0 mg of zinc or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a zinc prodrug; 2.0 mg of copper or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a copper prodrug; up to 200.0 mg of C26+ (6n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a C26+ (6n3) acid prodrug;200 mg of docosahexaenoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a docosahexaenoic acid prodrug; 40.0 mg of at least one C26-34 (5n-3) acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a C26-34 (5n-3) acid prodrug; and 40.0 mg of eicosapentanoic acid or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of an eicosapentanoic acid prodrug.

20. Composition, according to claim 18 or Petition 870260052112, dated 05 / 29 / 2026, page 97 / 216 7 / 9 19, characterized in that it further comprises 10.0 mg of lutein or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a lutein prodrug and 2.0 mg of zeaxanthin or an equivalent amount of a prodrug, pharmaceutically acceptable salt and / or pharmaceutically acceptable salt of a zeaxanthin prodrug.

21. Composition, according to any one of claims 1 to 20, characterized in that it further comprises at least one additional active ingredient.

22. Composition according to claim 21, characterized in that at least one additional active ingredient is chosen from: vitamin C, prodrugs thereof and pharmaceutically acceptable salts according to any of the foregoing; vitamin E, prodrugs thereof and pharmaceutically acceptable salts according to any of the above; zinc, prodrugs thereof and pharmaceutically acceptable salts of any of the above; copper, prodrugs thereof and pharmaceutically acceptable salts of any of the above; vitamin B1, prodrugs thereof and pharmaceutically acceptable salts of any of the above; vitamin B2, prodrugs thereof and pharmaceutically acceptable salts of any of the above; vitamin B3, prodrugs thereof and pharmaceutically acceptable salts of any of the above; vitamin B5, prodrugs thereof, and pharmaceutically acceptable salts of any of the above items;vitamin B6, prodrugs thereof and pharmaceutically acceptable salts of any of the above items; Petition 870260052112, dated 05 / 29 / 2026, p. 98 / 216 8 / 9 vitamin B7, prodrugs thereof and pharmaceutically acceptable salts of any of the above items; vitamin B9, prodrugs thereof and pharmaceutically acceptable salts of any of the above items; vitamin B12, prodrugs thereof and pharmaceutically acceptable salts of any of the above items; lutein, prodrugs thereof and pharmaceutically acceptable salts of any of the above items; and zeaxanthin, prodrugs thereof and pharmaceutically acceptable salts of any of the above items.

23. Composition, according to any one of claims 1 to 22, characterized in that it is in the form of one or more tablets, capsules, soft gels, liquid or powder.

24. Composition, according to any one of claims 1 to 23, characterized in that it is a daily dosage.

25. Use of a composition, as defined in any one of claims 1 to 24, characterized in that it is for the manufacture of a nutritional or dietary supplement, pharmaceutical preparation and / or product to delay the progression and / or onset of macular degeneration in an individual in need thereof.

26. Use of a composition, as defined in any one of claims 1 to 24, characterized in that it is for the manufacture of a nutritional or dietary supplement, pharmaceutical preparation and / or product for treating and / or preventing at least one disease, disorder and / or condition associated with a loss of visual acuity in an individual.

27. Use, according to claim 25 or 26, characterized in that the nutritional or dietary supplement, pharmaceutical preparation and / or product contains instructions for daily use in one, two, three or four daily doses.

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