Intraocular drug delivery system and method of use

Abstract

Embodiments of the present disclosure relate to an intraocular drug delivery device and method for delivering at least one therapeutic agent to an eye of a subject. The method includes implanting an intraocular implant into the subject's eye and adjacent to a fluid-permeable membrane of the subject's eye. The intraocular implant is supported at a position on the surface of the fluid-permeable membrane. The intraocular implant includes a drug delivery component having at least one therapeutic agent embedded within a non-biodegradable, non-bioerodible polymer matrix. The devices and methods disclosed herein can further include delivering at least one therapeutic agent to the eye of the subject according to a near-zero order dissolution rate of the at least one therapeutic agent.

Description

Technical Field

[0001] The present disclosure relates to the field of intravitreal drug delivery systems, pharmaceutical compositions, and methods of using the same.

Background Art

[0002] An intraocular lens (IOL) is an artificial lens for the eye that can be implanted to replace a patient's natural lens after the natural lens has been removed. By way of example, a patient's natural lens can be removed because it is affected by cataracts, and an IOL can be implanted to provide clear vision and a degree of focusing for the patient. An intraocular lens can also be implanted in a patient without removing the natural lens (phakic intraocular lens or PIOL) to correct extreme nearsightedness or farsightedness.

[0003] In certain situations, it may be advantageous to administer one or more therapeutic agents to the eye simultaneously with implantation of the IOL to reduce various side effects of the IOL or to treat other conditions of the eye that may coexist with the condition causing the cataract. Side effects such as infection and inflammation, as well as conditions such as glaucoma, can be treated using therapeutic agents that can be incorporated into the IOL or additional devices that can be attached to the IOL. In addition to IOLs, lens-free ocular implants can be implanted to address such various conditions.

[0004] Previous attempts have disclosed various configurations of drug delivery components used in conjunction with IOLs, including the placement of drug delivery components on the haptics of the IOL. The devices and methods described below provide a more efficient and / or robust approach for fixing drug delivery components to an IOL, as well as related drug delivery systems.

Summary of the Invention

[0005] In one aspect, the present disclosure relates to an intravitreal drug delivery system that includes an ophthalmic implant and a drug delivery component, the drug delivery component being non-biodegradable and including at least one therapeutic agent embedded within a matrix (e.g., a polymeric matrix). In certain embodiments, the drug delivery component can be configured for zero-order drug release rate, e.g., for long-term delivery. In certain embodiments, the ophthalmic implant can be an intraocular lens assembly.

[0006] In one embodiment of the present disclosure, a stabilized intravitreal drug delivery system is provided. According to this embodiment, the stabilized intravitreal drug delivery system includes an intraocular lens (IOL) assembly and a drug delivery component. The IOL assembly includes a lens and a haptic extending outwardly from a plane of the lens and configured to engage the drug delivery component, and the IOL assembly is configured for implantation into an eye of a subject. The drug delivery component includes at least one therapeutic agent, component, and / or formulation, and a fixation portion sized and dimensioned to receive the haptic and having an aperture configured to secure the drug delivery component to the IOL assembly. In certain embodiments, the haptic includes a retention tab on the haptic, the retention tab having an outer surface and an inner surface for providing an inner portion at a junction of the haptic to the lens. The haptic further includes a gusset on a surface opposite the inner portion at a junction of the optical portion / lens of the haptic. In some embodiments, the fixation portion of the drug delivery component, and the retention tab, inner portion, and gusset of the haptic are configured to secure the drug delivery component to the IOL assembly in a manner that stabilizes relative movement of the ophthalmic implant and the drug delivery component.

[0007] In certain embodiments, attachment of the drug delivery component to the intraocular lens assembly or other intraocular implant is achieved by releasable or non-releasable means and can be accomplished during manufacture of the IOL assembly, immediately before or after implantation during the perioperative period, or intraoperatively or postoperatively in the same procedure as when the IOL assembly is implanted.

[0008] In other embodiments, the drug delivery component can include first and second drug delivery components and can be configured to allow placement of the second drug delivery component within, in, or surrounded by the first drug delivery component. Placement of the second drug delivery component within the first drug delivery component can be accomplished at the time of manufacture of the IOL assembly, perioperatively immediately before or after implantation, intraoperatively, or in the same procedure by which the IOL assembly is implanted. In some embodiments, the first and / or second drug delivery components are expendable and can be removed and replaced in a surgery including any time after the surgery in which the IOL assembly was first inserted, including the long term after the procedure is complete, when the first and / or second drug delivery components are expended. The first and / or second drug delivery components are expendable and are removed and replaced in a surgery that can be accomplished from days to years after the surgery in which the IOL assembly was first inserted when the first and / or second drug delivery components are expended. BRIEF DESCRIPTION OF THE DRAWINGS

[0009]

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DETAILED DESCRIPTION

[0010] In certain embodiments, the present disclosure relates to an intraocular drug delivery system including, but not limited to, an ophthalmic implant and a drug delivery component, the drug delivery component being non-biodegradable and including at least one therapeutic agent releasably embedded within a matrix (e.g., a polymer matrix). In certain embodiments, the drug delivery component can be configured, for example, for long-term delivery, for a zero-order drug release rate. In certain embodiments, the ophthalmic implant can be an intraocular lens assembly.

[0011] Figures 1 and 2 show the placement and use of an intraocular drug delivery system within a patient's eye. The eye 1 includes the crystalline lens 2 (the natural lens of the eye) and the lens capsule 3, the anterior chamber 4 containing aqueous humor that fills the space between the cornea 5 and the iris 6 and the space between the cornea and the iris, and the posterior chamber 7 between the iris and the lens capsule. The posterior cavity / vitreous 8 is the large space between the crystalline lens 2 and the retina 9. The natural lens 2 of the eye 1 is characterized by the optical axis 10. (In the following description of the intraocular drug delivery system, the terms posterior and anterior are used in relation to the anatomical structure of the eye, with the cornea being anterior and the retina being posterior). Figure 2 shows the intraocular placement of an intraocular drug delivery system 11 including an ophthalmic implant 12 and a drug delivery component 30 embedded within the lens capsule of the subject (described in more detail herein). The lens capsule can include the natural lens, an intraocular lens, or may contain no lens at all.

[0012] Certain aspects of the present disclosure relate to an intraocular drug delivery system including an ophthalmic implant and a drug delivery component, wherein the ophthalmic implant and the drug delivery component are connected in a configuration that stabilizes the relative movement of the ophthalmic implant and the drug delivery component. In certain embodiments, the ophthalmic implant can be an intraocular lens assembly (IOL). However, the present disclosure is not so limited, and the ophthalmic implant can be any suitable ophthalmic implant configured to include a drug delivery component that stabilizes and holds the features described herein. The intraocular drug delivery system can include a drug delivery component configured to deliver various therapeutic agents for treating various conditions and diseases of the eye.

[0013] Figures 3A and 3B illustrate an exemplary intraocular drug delivery system 20 that can include an IOL assembly 22 and one or more drug delivery components 30. The IOL assembly includes an annular structure 23 that surrounds an optical portion / lens 24 at its center. One or more haptics 28 extend outwardly from the plane of the annular structure 23 or a parallel plane. The optical portion / lens 24 can include an optical portion having a vision correction portion. Alternatively, the annular structure 23 can be a scaffold for providing structural support without simply having an optical portion / lens 24 positioned therein. If the IOL assembly 22 does not include an optical portion / lens 24, the annular structure 23 can be a complete ring (continuous outer perimeter) or the annular structure 23 can be a partial ring (C-shaped) with non-matching ends. The drug delivery component 30 is configured for attachment (preferably releasable attachment) to the haptic 28 of the IOL assembly 22. The intraocular drug delivery system 20 includes a front face and a rear face for the subject's eye when implanted. In other embodiments, the intraocular drug delivery system 20 can optionally include other devices such as a capsular tension ring or a capsular scaffold for holding the system in place during use.

[0014] The outer extent of the haptic 28 is of sufficient length to contact the lens capsule of the subject's eye when the system is implanted, while the radially outer extent of the drug delivery component 30 is preferably shorter than the radially outer extent of the haptic 28 so as to avoid the drug delivery component 30 contacting the lens capsule in, for example, the equatorial region of the lens capsule of the subject's eye when installed on the implanted IOL assembly 22. As shown, FIG. 3A shows one embodiment in which the drug delivery component 30 is configured to dimensionally correspond to the size and shape of the optic-haptic junction region, and FIG. 3B shows one embodiment in which the drug delivery component 30 is configured to be dimensionally larger than the optic-haptic junction region. However, the present disclosure is not so limited, and the drug delivery component 30 can be sized to be formed in any manner suitable for the intended use, such as, for example, one-quarter around the optic, one-third around the optic, one-half around the optic, and the like. In some aspects, when installed on the implanted IOL assembly 22, the drug delivery component 30 is positioned to cover the entire optic-haptic junction region, or a portion or fragment thereof.

[0015] In one embodiment, the shape of the drug delivery component 30 can be a slab. In some aspects, the drug delivery component 30 can be a rectangular (e.g., square) pad or slab, or an oval configuration, or any applicable shape. In one embodiment, the drug delivery component 30 can be a flat configuration. In some embodiments, the shape of the drug delivery component 30 can be a block, sphere, cylinder, or other configuration suitable for delivering one or more therapeutic agents, compositions, and / or formulations.

[0016] The drug delivery component 30 can define a refractive index or refractive indices such that the component is composed of materials having similar refractive indices. According to these embodiments, the drug delivery component 30 can be composed of materials that cause little or no abnormal light vision in order to minimize or eliminate any unwanted light projection onto the retina and reduce or eliminate any unwanted reflections or images (e.g., not focusing light in any intended manner). In certain embodiments, the drug delivery component 30 has a neutral refractive index or no refractive index. In some embodiments, the refractive index of the drug delivery component 30 can be from about 1.1 to about 1.7. In other embodiments, the refractive index of the drug delivery component 30 can be from about 1.2 to about 1.6. In certain embodiments, the refractive index of the drug delivery component 30 is from about 1.3 to about 1.5. In some embodiments, the refractive index of the drug delivery component 30 is about 1.4.

[0017] Figures 4A, 4B, and 4C show an exemplary IOL assembly 22 of the present disclosure. As shown in Figure 4A, the haptic 28 is configured with retention and stabilization features including a retention tab 40 and a gusset 44. The retention tab 40 at the central end of the haptic 28 has an outer surface and an inner surface at the optic-haptic junction 48 and provides an inner portion 42. Opposite the inner portion 42 formed by the retention tab 40, the haptic 28 includes a curved notch or gusset 44 that facilitates flexion and bending of the haptic during use. In some embodiments, the outer surface of the retention tab 40 includes a radial surface and the inner surface of the retention tab includes a radial surface such that the inner portion of the retention tab has a curved inner portion at the junction of the haptic to the lens.

[0018] Between the retention tab 40 and the gusset 44, the front surface of the haptic 28 provides an upper surface 46 that can interact with at least a portion of the drug delivery component 30 to stabilize its orientation during use (see FIG. 4A). In some embodiments, the upper surface 46 can be sized and formed to conform to the size and shape of the drug delivery component 30 (e.g., to interact with the entire drug delivery component 30 or substantially the entire drug delivery component 30). As shown in FIG. 4B, in some embodiments, the portion 81 that connects the haptic 28 to the optical body 82 is formed with a contoured relief cut 84 that provides additional stability to the drug delivery component during use and / or to maintain the PCO barrier. FIG. 4C shows a detailed view of the relief cut 84 and the surface 46 of the haptic 28.

[0019] Figure 5 shows an exemplary drug delivery component 30 of the present disclosure. The drug delivery component 30 can include at least one therapeutic agent, formulation, or pharmaceutical composition that occupies the entirety of the drug delivery pad 70 and is uniformly distributed or occupies a portion thereof (such as an internal drug delivery pad, gel, or drug elution matrix). The drug delivery pad 70 can elute at least one therapeutic agent, formulation, or composition. In certain embodiments, the drug component 100 (also referred to as a drug core or polymer core in certain embodiments) can be soluble, non-biodegradable, and / or biodegradable over time. In some embodiments, the drug component 100 is a solid. In some embodiments, the drug component 100 is a liquid composition containing at least one therapeutic agent. In other embodiments, the drug delivery pad 70 is not soluble, biodegradable, or biodegradable over time. According to these embodiments, at least one therapeutic agent, formulation, or composition can elute from the drug delivery pad 70, and the drug delivery pad 70 maintains its configuration without dissolving, decomposing, and / or eroding through the elution process. In certain embodiments, at least one therapeutic agent (e.g., bimatoprost) can include an amorphous solid, crystalline, microparticles, microbeads, spray-dried compounds or agents, lyophilized pharmaceuticals, or other suitable forms, or combinations thereof. In certain embodiments, at least one therapeutic agent includes a crystalline form of at least one therapeutic agent, an amorphous form, a mixture of a crystalline form and an amorphous form, or other dried forms of at least one therapeutic agent, including but not limited to a conjugated form or a salt form of at least one therapeutic agent, or other derivative forms thereof. In some embodiments, at least one therapeutic agent can include a range of about 30% to about 70% crystalline form or about 40% to about 60% crystalline form. In other embodiments, at least one therapeutic agent can include a crystalline form in the range of 0% to about 20% (e.g., 0% crystals when at least one therapeutic agent is amorphous). The drug delivery component 30 can further include an attachment structure or fixing portion 50 attached to the rear side of the drug delivery pad 70.The attachment structure 50 can include a structure 55 that extends vertically and horizontally from the rear side of the drug delivery pad 70 and is connected by a band 60 to form an opening 65 (e.g., a slot, an aperture, or a compartment). The opening 65 is configured to receive a haptic of the IOL assembly such that a haptic (not shown) can pass through the opening 65. The attachment structure 50 can generally function as a drug delivery component retention loop and can be formed or made from any suitable material for its intended use. By way of non-limiting example, the securing portion 50 can be formed from a biocompatible polymer for ophthalmic use that is compatible with the intended therapeutic agent, such as a medical grade silicone or similar material. Further, the securing portion 50 can be attached to the drug delivery pad 70 by any method known in the art suitable for such purpose, such as co-molded medical grade adhesives, thermal bonding, and the like. Further features of the drug delivery component or drug dispenser 30 are described in U.S. Patent Application No. 63 / 226,507, filed Jul. 28, 2021, which is hereby incorporated by reference in its entirety.

[0020] The retention and stabilization features of the ophthalmic implant and the securing portion of the drug delivery component result in an intraocular drug delivery system configured to stabilize relative movement of the ophthalmic implant and the drug delivery component.

[0021] Figures 6A-6D show various views of an exemplary drug delivery component 80. More particularly, FIG. 6A shows an exploded isometric view of a drug delivery component 80 that includes many of the same features as the drug delivery component 30 of FIG. 5. As shown in FIG. 6A, the drug delivery component 80 includes a base structure 82 that includes a tray 84 and an attachment structure 86 that extends from the rear side of the tray 84. The attachment structure 86 facilitates attachment of the drug delivery component 80 to a haptic (not shown) of an intraocular implant. The attachment structure 86 of FIG. 6A can include the same or similar features as the attachment structure 50 of FIG. 5. Referring further to FIG. 6A, the attachment structure 86 includes a pair of posts 88 that extend from the rear side of the tray 84. The pair of posts 88 are connected to a band 90. Together with the rear side of the tray 84, the pair of posts 88, and the band 90, an opening 92 is formed for receiving a haptic of an intraocular implant.

[0022] The tray 84 of the base structure 82 includes a base surface 94 and an outer edge 96 that extends along the edge of the base surface 94. Together with the base surface 94 and the edge 96, the tray 84 forms a reservoir, trough, or recess 98 for receiving the drug component 100 shown in FIG. 6A. In certain embodiments, the base structure 82 can be formed of the same or a similar material as the encapsulating sheet 114 (described below). For example, the base structure 82 can be formed from a non-biodegradable, non-bioerodible material (such as a polymer). In certain embodiments, the polymer can be a cross-linked polymer. In other embodiments, the polymer can be a blended polymer. In some embodiments, the cross-linked polymer can have a molecular weight of about 5,000 to about 250,000 molecular weight (mw) or a cutoff of about 5,000 to about 200,000 mw. In certain embodiments, the base structure 82 can be formed from a biocompatible polymer such as silicone or a silicone composite material or a mixture of silicone. In certain embodiments, the biocompatible, non-bioerodible polymer can be formed by curing a two-part liquid silicone rubber mixture. In certain embodiments, the two-part liquid silicone rubber mixture can be formed by a predetermined ratio of two-part liquid silicone. In some embodiments, two-part silicone mixtures are well known in the art and any pharmaceutically acceptable silicone mixture is contemplated for use herein. For example, for long-term delivery, to encapsulate or immobilize at least one therapeutic agent. For example, the two-part liquid silicone rubber mixture can include x and y in a ratio of about 50:50, 55:45, 45:55, 40:60, 60:40. In another example, the ratio of x to y can be about 10:1. If the base structure 82 is a silicone or a mixture of silicone or a two-part liquid silicone rubber mixture that includes or does not include other non-bioerodible, biocompatible materials, the base structure 82 is non-bioerodible and / or non-biodegradable. That is, the base structure 82 does not erode when positioned in the eye, does not dissolve when positioned in the eye, and is non-absorbable in the eye after placement.Stated another way, when the base structure 82 is formed from a non-bioerodible, non-biodegradable material such as silicone, it retains its shape and structure within the eye and does not erode or degrade over time. Substances that erode or degrade within the eye can pose problems for visual acuity, cause irritation within the eye (e.g., iritis), cause infection within the eye, damage cells, result in cell death within the eye, or cause other side effects that can lead to permanent damage to the eye. In certain embodiments, the base structure 82 can be manufactured from non-bioerodible and / or non-biodegradable materials. By way of non-limiting example, the base structure 82 can be made from any inorganic non-bioerodible and / or non-biodegradable synthetic polymer (e.g., silicone, polysiloxane, or a mixture of two or more silicone materials), polyolefin (e.g., polyethylene), polymethacrylate, polystyrene, poly(vinyl acetate), polyurethane, and / or polytetrafluoroethylene, including but not limited to at least one material. In other embodiments, copolymers or mixtures of polymers can be used with these and similar agents, such as ethylene vinyl acetate. In other embodiments, the base structure 82 can be manufactured by a molding process such as injection molding or casting, or other molding processes known in the art. In yet other embodiments, the base structure 82 can be manufactured by an extrusion process or the like.

[0023] As shown in FIG. 6A, the drug component 100 (also referred to as a drug core or polymer core in certain embodiments) is sized and formed to be received within the reservoir 98 of the base structure 82 of the drug delivery component 80. That is, the shape of the drug component 100 is adapted to the reservoir 98 to fit and be received within the reservoir 98. The drug component 100 includes generally flat top and bottom surfaces 102, 104, and an edge between the bottom surfaces 102, 104, which edge includes convex end surfaces 108, concave end surfaces 110, convex end surfaces 108, and a pair of linear end surfaces 112 that face each other and are generally parallel to each other. The drug component 100 generally forms the shape of a bow-shaped pad.

[0024] The drug component 100 can include at least one active agent such as at least one therapeutic agent, formulation, or composition embedded within a biocompatible polymer matrix. The drug component 100 can be referred to as a drug core, or a polymer core when at least one active agent is embedded within the polymer matrix. According to these embodiments, the active agent, formulation, and / or composition can be mixed with a polymer (or a mixture of polymers) and formed into the shape of an arcuate pad as shown in FIG. 6A or other suitable shape. Once mixed, this combination of the active agent, formulation, or composition can be essentially uniformly dispersed and / or embedded within the polymer matrix (or a mixture of polymers). According to these aspects, the active agent, formulation, and / or composition can be embedded within the polymer matrix that constitutes the drug component 100. The polymer matrix having the embedded active agent, formulation, and / or composition can be placed into a mold for curing to produce the drug component 100. The drug component 100 is a drug elution component configured to provide a consistent or steady state release of the active agent, formulation, and / or composition from within the polymer matrix. The polymer mixed with the active agent, formulation, or composition can be a biocompatible, non-biodegradable polymer such as silicone or other polymer or a mixture of polymers disclosed herein. In certain embodiments, the biocompatible, non-biodegradable polymer (e.g., silicone) can be the same type of biocompatible, non-biodegradable polymer used to form the base structure 82.

[0025] In other embodiments, the drug component 100 effects zero-order release of at least one therapeutic agent, and is further illustrated and described with reference to FIGS. 8 and 9. As described herein, zero-order release (or elution) means that at least one therapeutic agent, formulation, and / or composition is released at a constant rate, or at a substantially constant rate, or at an essentially constant rate over a long period of time (e.g., several years). In certain embodiments, zero-order release means that at least one therapeutic agent, formulation, and / or composition is released at a steady-state rate, or at a substantially steady-state rate, over a long period of time (e.g., essentially steady-state release). In some examples, the period of zero-order release of at least one therapeutic agent, formulation, and / or composition is from about 3 months to about 10 years, or any period therebetween. In other embodiments, the period of zero-order release of at least one therapeutic agent, formulation, and / or composition is from about 6 months to about 6 years, or any time therebetween. In some examples, the period of zero-order release of at least one therapeutic agent, formulation, and / or composition is from about 9 months to about 3 years, or any time therebetween. In some embodiments, the period of zero-order release is from about 1 year to about 6 years, or any time therebetween.

[0026] In one embodiment, and further with respect to the above paragraph

[0035] , the drug component 100 can be formed from the same or a similar material as the base structure 82 and / or the encapsulation sheet 114. For example, the drug component 100 can be formed from a non-biodegradable, non-erosive polymer or a mixture of polymers. In one embodiment, the drug component 100 contains one or more dry pharmaceuticals mixed therein (e.g., mixed within a polymer core). In some aspects, one or more pharmaceuticals can be soluble when encapsulated by a membrane, for example when the membrane is within the base structure 82 and the encapsulation sheet 114. In one embodiment, one or more therapeutic agents can be dried when encapsulated within the core disclosed herein. In other embodiments, one or more therapeutic agents can be melted and mixed for encapsulation within the core. In some aspects, the drug component 100 is non-refillable. In other embodiments, one or more pharmaceuticals can be distributed uniformly or essentially uniformly through the non-biodegradable, non-erosive polymer or mixture of polymers forming the drug component 100. According to these embodiments, one or more pharmaceuticals can be delivered to a subject at an essentially steady-state rate over a predetermined period (e.g., from 1 month to about 10 years).

[0027] In certain embodiments, the drug component encapsulated within the polymeric matrix can include one or more therapeutic agents, formulations, and / or compositions used to treat, ameliorate, prevent, and / or reduce the risk of onset of an eye condition or disease. In certain embodiments, the drug delivery component 80 can include one or more therapeutic agents, formulations, and / or compositions from about 1 mg to about 1000 mg; or from about 10 mg to about 750 mg; or from about 50 mg to about 500 mg. In certain embodiments, two drug delivery components 80 can include one or more therapeutic agents, formulations, or compositions from about 2 mg to about 2,000 mg. In certain embodiments, the drug component encapsulated within the polymeric matrix can include one or more therapeutic agents, formulations, and / or compositions without preservatives, e.g., preservative-free. In some embodiments, for example, at least one therapeutic agent included within the core can include, but is not limited to, bimatoprost. According to these embodiments, bimatoprost can be from 1.0% to about 25.0% w / w. In other embodiments, at least one therapeutic agent can be as high as about 40% w / w, or about 50% w / w, or about 60% w / w, depending on the at least one therapeutic agent used and the polymeric matrix formed. In certain embodiments, one of ordinary skill in the art will understand that the polymeric matrix must be able to cure in the presence of one or more therapeutic agents.

[0028] In some embodiments, the drug delivery component 80, and more specifically, at least one of the polymeric matrix and the drug component 100 forming the polymeric core, the formulation, and / or the composition can comprise the following weight ratios. In certain embodiments, the weight ratio of at least one therapeutic agent to a biocompatible, non-biodegradable polymeric matrix can be a predetermined ratio of from about 100:1 (w / w) to about 1:100; or about 60:1 or 1:60, or from about 50:1 to about 1:50; or about 40:1 or 1:40, or from about 20:1 to about 1:20; or from about 10:1 to about 1:10; or from about 5:1 to about 1:5; or from about 3:1 to about 1:3 or any ratio between these ratios, or another predetermined ratio of the polymeric matrix to at least one therapeutic agent appropriate for the treatment period of delivery to the eye of the subject to be coated (e.g., from 1 month to about 10 years). In certain embodiments, the weight ratio of at least one therapeutic agent to the biocompatible polymeric matrix can be about 1:3 or about 2:3. In certain embodiments, the concentration of at least one of the therapeutic agent, formulation, and / or composition in the core region containing the at least one therapeutic agent, formulation, and / or composition can be from at least about 0.2% w / v to about 40% w / v. In other embodiments, the concentration of at least one of the therapeutic agent, formulation, and / or composition in the core region containing the therapeutic agent can be from at least about 0.4% w / w to about 40% w / w. In certain embodiments, the concentration of at least one of the therapeutic agent, formulation, and / or composition in the core region containing the at least one therapeutic agent, formulation, and / or composition can be from about 10% to about 40% w / v.

[0029] In certain embodiments, at least one therapeutic agent, formulation, and / or composition (e.g., bimatoprost) has a predetermined liquid content or water content. In some embodiments, the water content of at least one therapeutic agent, formulation, and / or composition is 5% or less. In some aspects, the water content of at least one therapeutic agent, formulation, and / or composition is 4% or less. In other embodiments, the water content of at least one therapeutic agent, formulation, and / or composition is 3% or less. In certain embodiments, the water content of at least one therapeutic agent, formulation, and / or composition is 2% or less. In some embodiments, the water content of at least one therapeutic agent, formulation, and / or composition is 1% or less.

[0030] In certain embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition mixed with the biocompatible, non-in-vivo-degradable polymers disclosed herein can be 50 μm or less. In some embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 45 μm or less. In some embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 40 μm or less. In certain embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 35 μm or less. In some aspects, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 30 μm or less. In other embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 25 μm or less. In some aspects, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 20 μm or less. In other embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 15 μm or less. In some embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition disclosed herein is 10 μm or less. In certain embodiments, the average particle size of at least one therapeutic agent, formulation, and / or composition, or substantially dry at least one therapeutic agent, formulation, and / or composition disclosed herein is 5 μm or less. In some embodiments, at least one therapeutic agent disclosed herein can be melted into a biocompatible, non-biodegradable matrix where particle size is irrelevant. In other embodiments, the drug delivery device can include cores of various sizes that accommodate at least one therapeutic agent, for example, when needed to appropriately house or encapsulate at least one therapeutic agent by increasing the size of the core used for the particle size of at least one therapeutic agent of the subject.

[0031] In some embodiments, and as further described in the previous paragraphs, at least one therapeutic agent, formulation, and / or composition used in the devices disclosed herein can be used for the treatment, prevention, or improvement of an eye condition. According to these embodiments, the eye conditions targeted by the devices and methods disclosed herein include, but are not limited to, glaucoma. Cataract inflammation, chronic uveitis, age-related macular degeneration (AMD), macular degeneration, ocular hypertension, inflammation, edema, eye infections, or combinations thereof, or other eye conditions. In certain embodiments, at least one therapeutic agent, formulation, and / or composition used in the devices disclosed herein can be used for the treatment, prevention, or improvement of eye conditions that require long-term treatment such as treatment for one month, several months to several years. In other embodiments, at least one therapeutic agent, formulation, and / or composition used in the devices disclosed herein can be used to treat, modulate, reduce, or inhibit the symptoms of an eye disease or a systemic disease or condition in a subject in need thereof, or otherwise provide a benefit thereto. According to these embodiments, at least one therapeutic agent, formulation, and / or composition encapsulated or incorporated within the drug delivery components disclosed herein can include, but is not limited to, bimatoprost, brimonidine, latanoprost, timolol, pilocarpine, brinzolamide, beta blockers, alpha agonists, Rho kinase inhibitors or ROCK inhibitors (e.g., ROCK1 (ROKβ) and ROCK2 (ROKα)), tyrosine kinase inhibitors (TKI) (e.g., carnosol and ursolic acid, imatinib, gefitinib, erlotinib, sorafenib, sunitinib, and dasatinib), Rho kinase inhibitors, adenosine receptor agonists, carbonic anhydrase inhibitors, adrenergic and cholinergic receptor activating agents, prostaglandin analogs, and their like agents, and any combinations thereof.In certain embodiments, at least one therapeutic agent, formulation, and / or composition used to treat an eye condition (e.g., glaucoma) can be liquid or can be in a substantially dry form or dehydrated or lyophilized or crystalline form. In certain embodiments, at least one therapeutic agent, formulation, and / or composition encapsulated or incorporated within the drug delivery components disclosed herein includes, but is not limited to, bimatoprost, brimonidine, and / or latanoprost in liquid, dehydrated, lyophilized, or crystalline form.

[0032] In other embodiments, and with respect to the previous paragraph, at least one therapeutic agent, formulation, and / or composition used in the devices disclosed herein can be used for the treatment, prevention, or amelioration of exudative age-related macular degeneration. According to these embodiments, at least one therapeutic agent, formulation, and / or composition can include, but is not limited to, aflibercept, bevacizumab, pegaptanib, ranibizumab, or other agents, steroids, one or more aptamers, and combinations thereof for treating exudative age-related macular degeneration.

[0033] In still other embodiments, and with respect to paragraphs

[0022] -

[0040] above, the therapeutic agent can be used in the treatment, prevention, or amelioration of atrophic age-related macular degeneration. According to these embodiments, the therapeutic agent, formulation, or composition used in the devices disclosed herein can include, but is not limited to, one or more complement factors, antioxidants, anti-inflammatory agents, or other suitable agents for treating or preventing atrophic age-related macular degeneration, and combinations thereof.

[0034] In other embodiments, and further with respect to paragraphs

[0022] to

[0040] above, at least one therapeutic agent, formulation, and / or composition can be used in the treatment, prevention, or amelioration of uveitis. According to these embodiments, the at least one therapeutic agent, formulation, and / or composition can include, but is not limited to, methotrexate or a similar agent (e.g., for attacking DNA within specific cell populations and reducing cell proliferation in the eye of a subject), an antibody for treating uveitis, dexamethasone, triamcinolone, other steroid drugs suitable for treating uveitis, or any combination thereof. In other embodiments, the at least one therapeutic agent can also include other pharmaceuticals or formulations that can reduce or inhibit anti-proliferative agents, mitotic inhibitors, anti-inflammatory agents, and the expansion of lens epithelial cells, e.g., for treating posterior capsular opacification, but is not limited thereto.

[0035] In still other embodiments, and further with respect to the above paragraphs

[0022] to

[0040] , antibiotics or other antibacterial agents, such as non-steroidal drugs like fluoroquinolones, ketorolac, and steroids like prednisolones, can be incorporated into the drug delivery components disclosed herein for postoperative management after eye surgeries such as cataract surgery, glaucoma surgery, etc. According to these embodiments, these implants can be used to improve the postoperative outcome of the eye and reduce complications.

[0036] In certain embodiments, and further with respect to paragraphs

[0022] -

[0040] above, at least one therapeutic or active agent can include, but is not limited to, one or more of a protein, polypeptide, polynucleotide, carbohydrate, fatty acid, small molecule, and an aptamer used to treat, prevent, or ameliorate a disease in the eye of a subject. In certain embodiments, at least one therapeutic or active agent includes one or more of a beta blocker, alpha agonist, antibiotic, chemotherapeutic agent (e.g., to reduce complications of excessive cell proliferation), prostaglandin analog, Rho kinase inhibitor such as a Rho-associated protein kinase inhibitor or ROCK inhibitor, tyrosine kinase inhibitor (TKI), carbonic anhydrase inhibitor, steroid, glucocorticoid, NSAID, antifibrotic agent, antioxidant, mitotic inhibitor, miotic agent, mydriatic agent, antineoplastic agent, 11β-prostaglandin F2α or 11-epi-PGF 2α agent, an antibody for treating an eye disease, other agents for reducing intraocular pressure, agents for promoting nerve regeneration, anti-inflammatory agent, anti-autoimmune agent, or a combination thereof. In certain embodiments, at least one therapeutic or active agent can include, but is not limited to, one or more of travoprost, latanoprost, tafluprost, timolol, bimatoprost, brimonidine, brinzolamide, aflibercept, bevacizumab, pilocarpine, ethacrynic acid, CNP / BNP / ANP, tetrahydrocannabinol (THC), pegaptanib, ranibizumab, methotrexate, dexamethasone, triamcinolone, ketorolac, dorzolamide, prednisone, cannabidiol (CBD), cannabinoid or other molecule derived from the cannabis plant, or a combination thereof, and / or other agents used to treat glaucoma, macular degeneration, or other eye conditions for a short or long period of time. In certain embodiments, at least one therapeutic or active agent can include, but is not limited to, bimatoprost and / or dexamethasone. In certain embodiments, bimatoprost as used herein includes, but is not limited to, bimatoprost Form A. In certain embodiments, at least one therapeutic agent, formulation, and / or composition includes bimatoprost in the form of bimatoprost Form A.In some embodiments, the bimatoprost agent used herein includes, but is not limited to, compositions of bimatoprost in bimatoprost form A or other bimatoprost forms, as well as derivatives or modified forms of bimatoprost (e.g., 15-epibimatoprost, 5,6-transbimatoprost).

[0037] In certain embodiments, and further with respect to the above paragraphs

[0021] -

[0047] , as at least one therapeutic agent or active agent or formulation or combination thereof, there may be mentioned, but not limited to, bimatoprost, brimonidine, latanoprost, timolol, pilocarpine, brinzolamide, aflibercept, bevacizumab, pegaptanib, ranibizumab, methotrexate, dexamethasone, triamcinolone, ketorolac, dorzolamide and / or prednisone or similar therapeutic agents or any agent capable of treating an eye condition, or any agent capable of treating any eye condition over a long period of time. In other embodiments, any therapeutic agent, composition, or formulation used for treating the eye that can be encapsulated within and delivered from a non-biodegradable polymer is contemplated for use in a drug delivery device as disclosed herein (e.g., encapsulated within a core). According to these embodiments, at least one therapeutic agent or active agent, formulation or composition, or combination thereof may be contemplated herein and introduced into, provided to, or be part of a drug delivery component for use in a device as disclosed herein.

[0038] Still referring to FIG. 6A, the drug delivery component 80 can include an encapsulation sheet 114 sized and configured to be sealed to or seal the edge 96 of the base structure 82 to encapsulate or enclose the drug component 100 within the reservoir 98. The sealing sheet 114 includes a top surface 116 (front surface), a bottom surface 118 opposite the top surface 116, and side edges extending between the top surface 116 and the bottom surface 118. The side edges include a concave end surface 120, a convex end surface 122, and a pair of linear side edges 124 at opposite ends of the encapsulation sheet 114. In some embodiments, the encapsulation sheet 114 can be formed of the same or similar material as the base structure 82. For example, the encapsulation sheet 114 can be formed from a non-biodegradable, non-biodegradable polymer. In certain embodiments, the encapsulation sheet 114 can be formed from a non-biodegradable, non-biodegradable biocompatible polymer such as silicone or a similar polymer. In other embodiments, where the polymer is silicone, the silicone can be the same type of silicone used to form the base structure 82 and / or the same type of silicone used to form a biocompatible polymer matrix that encapsulates at least one therapeutic or active agent, its composition and / or formulation. In some embodiments, the encapsulation sheet 114 can be formed by applying one or more layers of a biocompatible polymer over the drug component 100 disposed within the reservoir 98 of the base structure 82. The one or more layers of biocompatible polymer can be secured to the edge 96 of the base structure 82 to encapsulate, confine, or more tightly enclose the drug-containing component 100 therein.

[0039] In one embodiment, the base structure 82 and the encapsulation sheet 114 can be formed of the same or similar materials. For example, the encapsulation sheet 114 can be formed from a non-biodegradable, non-bioerodible polymer. Together, the encapsulation sheet 114 and the base structure 82 can form a non-biodegradable, non-bioerodible polymer film that surrounds or encapsulates the drug component 100. In this way, the polymer film formed by the encapsulation sheet 114 and the base structure 82 can form a matrix for eluting one or more pharmaceuticals from the drug component 100. In one embodiment, the polymer film does not have pores (e.g., mechanical apertures).

[0040] Figures 6B-6D illustrate various steps in the manufacturing process of the drug delivery component 80. Figure 6B shows an isometric view of the base structure 82 without the drug-containing component 100 or the encapsulation sheet 114. Figure 6C shows an isometric view of the base structure 82 having the drug component 100 disposed within the reservoir 98 of the tray 84 of the base structure 82. As shown in this figure, the shape of the drug-containing component 100 mimics the shape of the interior of the reservoir or the reservoir 98. That is, the generally flat bottom surface (not shown) of the drug-containing component 100 abuts the generally flat surface 94 of the tray 84 of the base structure 82. In one embodiment, the generally flat upper surface 102 of the drug-containing component 100 is exposed for encapsulation or exteriorization.

[0041] Figure 6D shows an isometric view of the base structure 82 with the drug-containing component 100 positioned therein and an encapsulation sheet 114 added that encloses the drug-containing component 100 therein. As shown in the figure, the encapsulation sheet 114 is secured to the edge 96 of the base structure 82. Application of the encapsulation sheet 114 can be performed by applying one or more layers of a biocompatible polymer such as silicone to the assembly of the base structure 82 and the drug-containing component 100 of Figure 6C. Alternatively, the encapsulation sheet 114 can be formed separately from the sheet shown in Figure 6A and adhered to the edge 96 of the base structure 82 with an adhesive (e.g., silicone or other suitable adhesive).

[0042] In the assembled state of the drug delivery component 80, as shown in FIG. 6D, the drug-containing component 100 is designed to elute or release at least one therapeutic agent, formulation, and / or composition through the polymer matrix and through the polymer exterior or polymer shell formed by the encapsulation sheet 114 and the base structure 82. In certain embodiments, the biocompatible polymer coating can have a thickness of about 25 percent to about 300 percent of the thickness of the biocompatible polymer matrix in which at least one therapeutic agent, formulation, and / or composition is embedded. In certain embodiments, the biocompatible polymer coating can have a thickness of about 50 percent to about 200 percent of the thickness of the biocompatible polymer matrix in which at least one therapeutic agent, formulation, and / or composition is embedded. In certain embodiments, the biocompatible polymer coating can have a thickness of about 100 percent to about 300 percent of the thickness of the biocompatible polymer matrix in which at least one therapeutic agent, formulation, and / or composition is embedded.

[0043] In certain embodiments, the drug pad (e.g., the drug component 100) is a diffusion control system. For example, the drug component 100 can provide rate-limiting diffusion of at least one therapeutic agent, formulation, and / or composition therein. In certain embodiments, the encapsulation layer (e.g., the base structure 82, the encapsulation sheet 114) is a control membrane or diffusion control. For example, the base structure 82 and / or the encapsulation sheet 114 can control the elution rate of at least one therapeutic agent, formulation, and / or composition. In some embodiments, the elution rate is a generally constant release rate (e.g., a daily release rate or a predetermined release rate). In certain embodiments, the lens capsule of the subject's eye is a microporous membrane that provides additional features for delivering at least one therapeutic agent, formulation, and / or composition to the subject's eye. For example, the lens capsule can provide biological or naturally occurring rate-limiting diffusion. In some embodiments, as at least one therapeutic agent, formulation, and / or composition elutes (or diffuses), the at least one therapeutic agent, formulation, and / or composition is delivered to the aqueous humor.

[0044] In some embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 can have a thickness of from about 1.0 micron to about 3.0 millimeters. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of from about 5.0 microns to about 2.0 millimeters. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of from about 10.0 microns to about 2.0 millimeters. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of from about 15.0 microns to about 2.0 millimeters. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of about 2.0 millimeters. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of about 1.0 millimeter. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of about 15.0 microns. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of about 10.0 microns. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding or coating the drug delivery component 80 has a thickness of about 5.0 microns. In certain embodiments, the silicone membrane (e.g., encapsulation sheet 114) surrounding the drug delivery component 80 has a thickness of about 1.0 micron.

[0045] In certain embodiments, the polymeric exterior is non-biodegradable and non-erosive. According to these embodiments, the polymeric exterior remains intact and does not degrade or deteriorate. In certain embodiments, the biocompatible polymer is hydrophilic. In other embodiments, the biocompatible polymer is hydrophobic. According to these embodiments, the dosage and duration of elution can be affected by the concentration of at least one therapeutic agent, composition and / or formulation in the drug-containing component 100 and / or the surface area of the drug-containing component 100. Thus, drug delivery components 80 of different sizes, as shown in FIGS. 3A and 3B, can be present, which can be selectively embedded to provide the desired dosage and duration of at least one therapeutic agent or active pharmaceutical ingredient, formulation or composition, or combinations of those agents.

[0046] In some embodiments, the drug delivery component 100 can include surface areas of various sizes. In certain embodiments, the front surface of the drug delivery component 80 can be from about 0.1 mm 2 to about 20.0 mm 2 or from about 0.3 mm 2 to about 15.0 mm 2 or from about 0.5 mm 2 to about 12.0 mm 2 In certain embodiments, the rear (i.e., bottom) surface area of the pad can be from about 0.1 mm 2 to about 20.0 mm 2 or from about 0.3 mm 2 to about 15.0 mm 2 or from about 0.5 mm 2 to about 12.0 mm 2 In some embodiments, the surface area around the pad can be from about 1.5 mm 2 to about 10 mm 2 In other embodiments, the total surface area of the drug delivery component 80 can be from about 18.0 mm 2 to about 100.0 mm 2 In still other embodiments, the total volume of the upper pad can be from about 1.5 mm 3 to about 8.0 mm 3 or from about 3.0 to about 5.0 mm 3Or it can be approximately. In certain embodiments, the total surface area of the drug delivery components disclosed herein is not the sum of the top, bottom, and perimeter areas, as the top, bottom, and perimeter areas can refer to the generally rectangular-shaped pad portion on the top. According to these embodiments, the total surface area can include the pad and attachment (e.g., fixed loop) features that are not considered in the top, bottom, and perimeter measurements.

[0047] In one embodiment, and further with respect to the above paragraph

[0057] , certain exemplary dimensions of the drug delivery component 80 of FIG. 6D can be as follows. The surface area of the front or top surface 116 of the drug delivery component 80 (shown as the top surface 116 of the encapsulation sheet 114 in FIG. 6D) can be about 8.5 square millimeters (mm 2 ). The bottom area of the pad can include a surface area of about 7.7 mm 2 . The perimeter surface area of the pad can be about 5.8 mm 2 . According to these embodiments, the total surface area of the entire pad can be about 41 mm 2 . In other embodiments, the volume of the entire upper pad can be about 4.0 cubic millimeters or about 3.57 cubic millimeters (mm 3 ).

[0048] In certain embodiments, the volume of the pad for drug delivery disclosed herein can vary depending on one or more therapeutic agents to be delivered, as well as the desired rate and duration of elution of one or more therapeutic agents from the pad. According to these embodiments, and further with respect to the above paragraph

[0056] , the drug delivery component 80 of FIG. 6D can be modified to have different sizes and shapes to accommodate different drug delivery characteristics (e.g., dosage, duration, timing of initial delivery, etc.). In another embodiment, the drug delivery components 80 of FIGS. 6A-6D can be made to match the drug delivery component 80 shown in FIG. 3B. Thus, certain exemplary dimensions of the smaller drug delivery component 80 as shown in FIG. 3A can be as follows. The surface area of the front or top surface of the drug delivery component 80 can be about 4.8 square millimeters (mm 2) can be. The bottom area of the pad can include a surface area of about 4.0 mm 2 . The surface area around the pad can be about 3.8 mm 2 . Thus, the surface area of the pad can be about 25.6 mm 2 . The volume of the entire upper pad can be about 2.02 cubic millimeters (mm 3 ).

[0049] Figures 7A and 7B each show a front view of an intraocular drug delivery system 700 having drug delivery components 80 of two different sizes and embedded within the lens capsule 702. The drug delivery components 80 can be sized and formed to be positioned within the lens capsule 702 of an eye of a subject (e.g., a patient). In some embodiments, the drug delivery system 700 is configured to be attached to the lens capsule 702. In some aspects, the drug delivery system 700 can be delivered through the lens capsule 702. As shown in FIGS. 7A and 7B, the lens capsule 702 includes an anterior opening 704 formed during surgery to provide access to the lens capsule 702. The intraocular drug delivery system 700 can be introduced into the eye of a patient through a small incision at the limbus of the cornea and into the lens capsule 702 through the anterior opening 704. The intraocular drug delivery system 700 can be delivered through the anterior opening 704 via an access cannula (not shown) or other injector. In certain embodiments, the intraocular drug delivery system 700 is flexible such that it can be folded or rolled and then opened or unfolded. In some aspects, when the intraocular drug delivery system 700 is folded or rolled and / or when it is then opened or unfolded, the drug delivery components 80 can be secured to the lens 24 or alternatively to the haptic 28. In some examples, the IOL assembly 22 is configured to form a fold such that the drug delivery components 80 can be positioned within an injector by an access cannula or other means while the drug delivery components 80 are secured to the IOL assembly 22 (e.g., secured at the haptic-lens junction). When the IOL assembly 22 is folded (i.e., forms a fold), the drug delivery components 80 can remain secured to the IOL assembly 22 and also remain outside the fold of the IOL assembly 22. In this way, the drug delivery components 80 do not impede the folding of the IOL assembly 22 and do not make the IOL assembly 22 bulkier than it would be without the drug delivery components 80. The intraocular drug delivery system 700 can be in a folded orientation within the access cannula.Once delivered into the lens capsule 702, the intraocular drug delivery system 700 expands into the shapes shown in FIGS. 7A and 7B, respectively. In each figure, the upper or front surface 116 of the encapsulation sheet 114 of the drug delivery component 80 is adjacent to or faces the inner surface of the anterior portion of the lens capsule 702. As shown in the figures, the lens 24 is generally positioned coaxially with the anterior opening 704, and the haptic 28 extends outwardly therefrom toward the inner surface of the lens capsule 704. The haptic 28 generally maintains the position of the system 700 in place within the lens capsule 702 so that the lens 24 functions properly. In certain embodiments, when the intraocular drug delivery system 700 is implanted, the drug delivery component 80 is implanted between the anterior and posterior capsule surfaces of the eye. In certain embodiments, the intraocular drug delivery system 700 is configured to maintain its shape after being implanted within the lens capsule 702 until the lens capsule closes over the intraocular drug delivery system 700.

[0050] For initial placement of the intraocular drug delivery system 700, the drug delivery component 80 can be secured to the IOL assembly 22 prior to inserting both into the eye, and the assembled system 700 can be folded, passed through an incision in the cornea, and then released into the lens capsule 702. Alternatively, for initial placement of the intraocular drug delivery system, an IOL can first be inserted through an incision, released into the lens capsule 702, and then the drug delivery component 80 can be inserted through the incision and the drug delivery component 80 manipulated to slide the securing portion above the haptic, thereby securing the drug delivery component to the haptic and the IOL assembly, such that the drug delivery component 80 can be secured to the IOL assembly 22 after insertion of the IOL into the eye.

[0051] As shown in FIGS. 7A and 7B, the drug delivery component 80 can generally be positioned within the lens capsule 702 and radially outside the anterior opening 704. And when positioned within the eye, the drug delivery component 80 elutes a therapeutic agent from within the lens capsule 702 into various anatomical structures within the eye. The therapeutic agent can elute within the lens capsule 702, through the lens capsule 702, and / or through the anterior opening 704 of the lens capsule 702 to disperse the therapeutic agent throughout the eye. In certain embodiments, the intraocular drug delivery system 700 is not configured to be disposed on the surface of the eye. In these embodiments, after the intraocular drug delivery system 700 is implanted, the intraocular drug delivery system 700 does not contact the surface of the eye.

[0052] As described above, the drug delivery component 80, as well as the IOL assembly 22, are non-biodegradable (also described as non-bioerodible). According to the embodiments disclosed herein, the shapes and structures of both the drug delivery component 80 and the IOL assembly 22 do not change over time when at least one therapeutic agent, composition, and / or formulation of the drug delivery component 80 elutes therefrom.

[0053] In some embodiments, the anterior capsule surface area of the human eye's lens capsule 702 can be about 30 mm 2 ~ about 100 mm 2 or about 40 mm 2 ~ about 90 mm 2 or about 35 mm 2 or about 83 mm 2 or about 57 mm 2 In certain embodiments, according to these embodiments, each of the drug delivery components 80 shown in FIG. 7A can have a front surface area of about 8.5 mm 2 . In certain embodiments, two drug delivery components 80 are used to provide a total surface area of about 17.0 mm 2 for an 80 mm 2It can be configured to be positioned adjacent to the anterior lens capsule 704. In this example, approximately 21% of the anterior capsule surface area can abut against the drug delivery component 80. For the drug delivery component 80 shown in FIG. 7B, each of the drug delivery components 80 has a front surface area of about 4.8 mm 2 . Using two drug delivery components 80, a total surface area of about 9.6 mm 2 is configured to be positioned adjacent to the anterior lens capsule 704 of 80 mm 2 . Thus, approximately 12% of the anterior capsule surface area can abut against the drug delivery component 80. Depending on the size of the human anterior capsule surface area and the size of the drug delivery component, other examples can be used.

[0054] In certain embodiments, the drug delivery system 700 of FIG. 7A can be sized (e.g., shaped, dimensioned) and configured (e.g., concentrated) for the release period of at least one therapeutic agent, formulation, and / or composition. For example, the at least one therapeutic agent can have a concentration such that the release period is from about 3 years to about 10 years. In certain embodiments, the drug delivery system 700 of FIG. 7A is sized and configured to release a therapeutic agent at a release rate of about 80 to about 150 nanograms (ng) per day for about 3 years (e.g., about 120 ng / day of bimatoprost). As shown in FIG. 7B, by reducing the surface area of the drug delivery component 80, the drug delivery system 700 is sized and configured to release at least one therapeutic agent (e.g., bimatoprost) at a release rate of about 60 ng per day for about 3 years. In certain embodiments, the amount of therapeutic agent within the polymer matrix can be decreased to provide a shorter release while still providing a consistent release rate. In one embodiment, the drug delivery component 80 can deliver a therapeutic agent at a consistent release rate of about 20 ng / day to 300 ng / day over about 12 months to about 10 years, or any time therebetween. In certain embodiments, the drug delivery component 80 can deliver at least one therapeutic agent at a consistent release rate of about 20 ng / day to 300 ng / day for about 12 to about 6 years, or any time therebetween. In certain embodiments, the drug delivery component 80 can deliver at least one therapeutic agent at a consistent release rate of about 20 ng / day to 300 ng / day for about 24 to about 3 years. In certain embodiments, the drug delivery component 80 can deliver at least one therapeutic agent for up to 10 years, or any predetermined period, before the drug delivery component 80 requires replacement. In some embodiments, the drug delivery component 80 can deliver at least one therapeutic agent at a consistent release rate of about 20 ng / day to 300 ng / day for up to 10 years. In some embodiments, the release rate of the at least one therapeutic agent, composition, and / or formulation is about 30 ng / day.In certain embodiments, the drug delivery devices disclosed herein reduce drug waste, over - dosing, toxicity, increase efficacy, and / or reduce the need for compliance for the scheduled delivery of at least one therapeutic agent contemplated herein that the subject adheres to.

[0055] In certain embodiments, the drug delivery system 700 can deliver at least one therapeutic agent for about one week to about 120 months (e.g., for an extended period), depending on the condition of the eye and the subject being treated. For example, the concentration of at least one therapeutic agent can be designed or adapted to provide for a predetermined period until the release of at least one therapeutic agent for treating the eye of the subject (e.g., a patient) is complete, or until some desired endpoint, or for long - term lifelong treatment (e.g., if the drug delivery components are replaced as needed). In certain embodiments, the drug delivery system 700 can deliver at least one therapeutic agent for about one week to about 10 years. For example, the drug delivery system 700 can deliver at least one therapeutic agent for at least one year. In certain embodiments, the drug delivery system 700 can deliver a therapeutic agent for at least six months (i.e., six months or more). In certain embodiments, the drug delivery system 700 can deliver a therapeutic agent for at least three years (i.e., three years or more). In certain embodiments, the drug delivery system 700 can deliver a therapeutic agent for six months to about six years. For example, the drug delivery system 700 can deliver a therapeutic agent for about 60 months. In certain embodiments, the drug delivery system 700 can deliver a therapeutic agent over 72 months or more.

[0056] The amount or concentration of at least one therapeutic agent mixed with the polymer can affect the duration of elution (e.g., 12 months, 24 months, 36 months, etc.), but the thickness of the biocompatible polymer encapsulation layer or shell surrounding the drug-containing component 100 can also affect the initial and / or final elution rate of the at least one therapeutic agent. For example, the elution rate can be partially determined by the thickness of the encapsulation layer while still providing an approximately zero-order or essentially zero-order or approximately steady-state release rate of the at least one therapeutic agent. In some embodiments, there is no encapsulation layer. In other embodiments, there is an encapsulation layer of about 10 to about 500 microns, or about 20 to about 400 microns, or about 30 to about 300 microns, or about 50 to about 300 microns. Further, the solubility, diffusivity, and / or bioavailability of the at least one therapeutic agent, composition, and / or formulation embedded or encapsulated within the polymer can affect the elution rate.

[0057] In certain embodiments, and further with respect to the above paragraph

[0066] , it should be noted that the two drug delivery components 80 on the IOL assembly 22 can include different therapeutic agents or mixtures or combinations thereof, such as those encapsulated within one drug delivery component 80 and those encapsulated within the other drug delivery component 80. In certain embodiments, each of the drug delivery components 80 can be the same size, as shown in FIGS. 7A and 7B. Alternatively, the IOL assembly 22 can include two drug delivery components 80 of different sizes on the same assembly. According to this example, there can be one drug delivery component 80 having the size shown in FIG. 7A and one drug delivery component 80 having the size shown in FIG. 7B. According to these embodiments, the at least one therapeutic agent encapsulated within the drug delivery component 80 can have a different concentration of the at least one therapeutic agent in one drug delivery component 80 compared to the other.

[0058] In one embodiment, the drug delivery system 700 of FIG. 7A can be sized and configured to elute different doses of at least one therapeutic agent at the same or different total release times. In one embodiment, at least one therapeutic agent can be configured to each have a release time of about 3 years to about 10 years, or any time therebetween. In one embodiment, at least one therapeutic agent can have a release time of about 1 week to about 10 years. In another embodiment, at least one therapeutic agent can have a release time of at least 1 week to about 10 years, or each drug delivery component 80 of two or more drug delivery components 80 on the IOL can contain at least one therapeutic agent having a different release date completion than the drug delivery component 80.

[0059] In one embodiment, at least two therapeutic agents (targeting the same or different eye conditions) can be encapsulated in the core of the drug delivery devices disclosed herein and can have the same or different release rates per day for each therapeutic agent. In one embodiment, two therapeutic agents (whether the same or different) can be provided and can have a release rate of about 2 to about 2000 ng / day, or about 2 to about 200 ng / day, depending on the agent. In one embodiment, at least two therapeutic agents (whether the same or different) can be provided and can have a release rate of about 30 ng per day for each therapeutic agent, or can have different release rates depending on the condition being treated.

[0060] Although drug delivery system 700 is described as being implanted within the lens capsule 702 of the eye, the systems 700 described herein (with or without an optical portion / lens) can be delivered into other regions of the eye, such as a sulcus or ciliary sulcus. In other embodiments, the drug delivery components 80 described herein are attached to other systems, such as the groove implant / drug delivery platform illustrated and described in PCT / US2021 / 057104, filed October 28, 2021, which is hereby incorporated by reference in its entirety for all purposes, and can deliver an active agent to the eye at a constant rate. Such devices can be supported within a groove, as shown in FIG. 2 of PCT / US2021 / 057104.

[0061] In certain embodiments, a kit is provided. In some embodiments, the kit can include a drug delivery component 80 and instructions for use. In some aspects, the kit can include a drug delivery system 700. In some aspects, the kit can include a package for storing and / or transporting the drug delivery component 80 and / or the drug delivery system 700. In one aspect, the kit can include a system for securing the drug delivery component 80 to the lens 24 or otherwise to the haptic 28.

[0062] As shown in FIG. 8, which is a graph 800 of daily release or elution (in micrograms) of bimatoprost in vitro versus time (days), the release rate over a 400-day study was essentially zero-order and / or steady-state elution rate. The target release rate in this study for rabbits was 0.050 - 0.100 micrograms per day. As shown in FIG. 8, the average release rate was in the range of about 0.075 micrograms to about 0.100 micrograms, slightly less than 0.100 micrograms per day. The graph supports zero-order release, which indicates that there is a consistent amount of drug released per unit time over a given duration.

[0063] As shown in FIG. 9, FIG. 9 is a graph 900 of bimatoprost, an example of a therapeutic agent disclosed herein, sampled in aqueous humor (ng / mL) over time (days), and various doses were tested, for example, in dogs. In this example, there were dogs in the low-dose group (Grp 1), dogs in the medium-dose group (Grp 2), dogs in the high-dose group (Grp 3), and dogs in the placebo group (Grp 4). The placebo or control group (Grp 2) showed 0 ng / ml of bimatoprost. The average measured values of bimatoprost in the aqueous humor of the other groups increased with higher doses provided to the dogs. As seen in the low-dose group (Grp 1), medium-dose group (Grp 2), and high-dose group (Grp 3), the levels of bimatoprost in the aqueous humor showed a zero-order elution rate over a test period of about 113 days.

[0064] In certain embodiments, if the originally implanted drug delivery component 80 is depleted either by elution or bioerosion or no longer provides a therapeutic dose, a surgeon can perform a subsequent surgical procedure to remove the original drug delivery component, make another incision at the corneal border, and use a grasping tool to insert and attach a new drug delivery component to the haptic and IOL assembly. Removal of the original drug delivery component and replacement with a new one can be performed, for example, after the original drug delivery component is depleted or consumed or whenever it is desired to replace the original drug delivery component with a new one containing a replenished or different therapeutic agent, and can be performed after the incision made to implant the original drug delivery component has healed and thus a new incision needs to be made. During the surgical procedure, if necessary, the surgeon can insert a grasping tool to remove the original drug delivery component from the haptic and IOL assembly and remove it from the eye, insert a new drug delivery component, and use the grasping tool to manipulate the new drug delivery component to slide it over the haptic and thereby secure it to the IOL assembly. In certain embodiments, the new drug delivery component can be added to either an in-the-bag IOL or a sulcus IOL.

[0065] In the following paragraphs, a number of embodiments are disclosed. In one embodiment, a drug delivery matrix for use within an eye of a subject is disclosed, the drug delivery matrix having a polymeric core that is non-erosive, non-biodegradable and that has one or more pharmaceuticals mixed therein, and a non-erosive, non-biodegradable polymeric membrane surrounding the polymeric core, the non-erosive, non-biodegradable polymeric membrane controlling the rate of elution of one or more pharmaceuticals from the non-erosive, non-biodegradable polymer into the environment outside of the non-erosive, non-biodegradable polymeric membrane. According to these embodiments, the drug delivery matrix can comprise one or more of one or more pharmaceuticals, such as amorphous solids, crystalline, microparticles, spray dried compounds or agents, and lyophilized pharmaceuticals or combinations thereof. In other embodiments, one or more pharmaceuticals are soluble in the non-erosive, non-biodegradable polymer of the polymeric core.

[0066] In certain embodiments, the drug delivery matrix can be in the shape of a rectangular pad, square pad, flat configuration, slab, block, sphere, or cylinder. In other embodiments, the drug delivery matrix comprises at least one drug delivery rectangular pad, square pad, block, or slab associated with a haptic of an intraocular lens (IOL). In yet other embodiments, at least one drug delivery rectangular pad, square pad, block, or slab is associated with an IOL haptic-optic junction. In some embodiments, the drug delivery component having the polymeric core is non-refillable. In one embodiment, the drug delivery matrix has a neutral refractive index or no refractive index. In other embodiments, the drug delivery matrix is adapted to be positioned within the capsular bag of the eye. According to these embodiments, the drug delivery matrix is shaped and sized to be positioned within the capsular bag of the eye.

[0067] In some embodiments, the drug delivery matrix can include an implant body having a scaffold, which is associated with the drug delivery matrix. In some embodiments, the haptic of the devices disclosed herein extends outwardly from the scaffold.

[0068] In certain embodiments, the drug delivery matrix or drug delivery component can be a drug delivery matrix or component that does not contain a preservative. In some embodiments, the polymer core can be configured to store and contain the concentration of one or more pharmaceuticals and / or therapeutic agents for at least three months and then deliver the one or more pharmaceuticals and / or therapeutic agents to a subject to treat the subject for an eye condition. In certain embodiments, the polymer core stores and contains the concentration of one or more pharmaceuticals and / or at least one therapeutic agent for at least one year and is configured to deliver the one or more pharmaceuticals and / or therapeutic agents to a subject to treat the subject for an eye condition. According to these embodiments, the drug delivery component 100 and / or the drug delivery component 80 can be stored for an extended period of time, individually or in groups (e.g., in individual wraps or packages, or laminated and packaged), for subsequent introduction into the ophthalmic devices and / or IOLs contemplated herein.

[0069] In certain embodiments, the drug delivery component 80 can include at least one of a polymer core and a non-biologically erodible, non-biodegradable polymer, and at least one of the polymer core and the non-biologically erodible, non-biodegradable polymer film can be composed of one or more of silicone, polyurethane, polyethylene, polyvinyl acetate, polyethylene glycol, polymethacrylate, polystyrene, or polytetrafluoroethylene. In certain embodiments, at least one of the polymer core and the non-biologically erodible, non-biodegradable polymer film is composed of silicone or a mixture of silicones. In other embodiments, the drug delivery matrix can include a cross-linked polymer. In certain embodiments, the polymer or cross-linked polymer used herein can have a molecular weight cut-off of about 5,000 to about 250,000 mw or about 10,000 to about 200,000. In certain embodiments, the non-biologically erodible, non-biodegradable polymer is a biocompatible polymer. In some embodiments, the non-biologically erodible, non-biodegradable polymer film includes a non-porous polymer film, or a continuous or uniform film without pores, or a film without holes. According to these embodiments, this uniform film can enable a uniform distribution of at least one therapeutic agent to the eye of the subject. In certain embodiments, the non-biologically erodible, non-biodegradable polymer is a solid matrix having one or more pharmaceuticals (plural) mixed therein. In other embodiments, the solid matrix retains its shape upon elution of one or more pharmaceuticals (plural) or at least one therapeutic agent mixed therein.

[0070] In certain embodiments, and further with respect to the above paragraph, the drug delivery matrix of the IOL contemplated herein is not configured to be disposed on the surface of the eye. In some embodiments, and further with respect to the above paragraphs, the pharmaceutical(s) used in the drug delivery components disclosed herein can include, but are not limited to, one or more of a protein, polypeptide, polynucleotide, carbohydrate, fatty acid, small molecule, and / or an aptamer used to treat an eye condition or to deliver a therapeutic agent through a component or matrix. In some embodiments, at least one therapeutic agent can include, but is not limited to, an agent that reduces intraocular pressure, an antibiotic, an anti-inflammatory, a chemotherapeutic agent, an agent that promotes nerve regeneration, a steroid, an antioxidant, an anti-proliferative agent, a mitotic inhibitor, or a pharmaceutically acceptable salt thereof, or any combination thereof. In some embodiments, one or more pharmaceuticals can include, but are not limited to, one or more of a beta blocker, an alpha agonist, an antibiotic, a chemotherapeutic agent, a prostaglandin analog, a Rho kinase inhibitor, such as a Rho-associated protein kinase inhibitor or a ROCK inhibitor (e.g., ROCK1 (ROKβ) and ROCK2 (ROKα)), a tyrosine kinase inhibitor (TKI), a carbonic anhydrase inhibitor, a steroid, a glucocorticoid, an NSAID, an anti-fibrotic agent, an antioxidant, a mitotic inhibitor, a miotic agent, a mydriatic agent, an anti-neoplastic agent, an 11β-prostaglandin F2α or 11-epi-PGF 2α agent, an antibody, another agent that reduces intraocular pressure, an agent that promotes nerve regeneration, an anti-inflammatory agent, an anti-autoimmune agent, and any combination thereof. In one embodiment, the pharmaceutical or therapeutic agent disclosed herein can include, but is not limited to, travoprost, latanoprost, tafluprost, timolol, bimatoprost, brimonidine, brinzolamide, aflibercept, bevacizumab, pilocarpine, ethacrynic acid, CNP / BNP / ANP, tetrahydrocannabinol (THC), pegaptanib, ranibizumab, methotrexate, dexamethasone, triamcinolone, ketorolac, dorzolamide, prednisone, cannabidiol (CBD), a cannabinoid or other molecule derived from the cannabis plant, or one or more of other agents used to treat glaucoma, macular degeneration, or other eye conditions for a short or long period of time.In certain embodiments, the pharmaceutical(s) can include, but is not limited to, one or more of bimatoprost and dexamethasone.

[0071] In certain embodiments, the pharmaceutical(s) or at least one therapeutic agent can contain a liquid or water content of about 5.0%, 4.0%, 3.0%, 2.0%, 1.0%, or about 0.05% or less. In some embodiments, at least one pharmaceutical or at least one therapeutic agent or formulation or composition disclosed herein can include a particle size of about 50 μm, 45 μm, 40 μm, 30 μm, 25 μm, 20 μm, or 15 μm or less.

[0072] In some embodiments, the drug delivery matrix or drug delivery component can be associated with an intraocular lens (IOL). In certain embodiments, the drug delivery matrix or drug delivery component is associated with an intraocular lens (IOL). In some embodiments, the drug delivery matrix is configured to be fixed to the IOL. In some embodiments, the IOL includes a lens and a haptic extending outwardly from the lens at the lens-haptic junction, but is not limited thereto, and the IOL is configured to form a fold for positioning within an injector, and when the IOL forms the fold, the drug delivery matrix can be configured to be fixed to the haptic-lens junction while remaining outside the fold.

[0073] In some embodiments, a kit is contemplated. According to these embodiments, the kit can include any of the devices disclosed herein and instructions for use. In other embodiments, the kit can include a drug delivery component or drug delivery matrix. In certain embodiments, the kit can include an IOL for use with the drug delivery matrix. The kit further includes packaging for the drug delivery matrix. In some embodiments, the kit can include a system for attaching the drug delivery matrix to the IOL.

[0074] In other embodiments, a method for delivering at least one therapeutic agent to an eye of a subject using the devices disclosed herein is disclosed. In certain embodiments, the method includes a drug delivery component including a solid drug core and a solid non-bioerodible membrane encapsulating the solid drug core, the solid drug core including at least one therapeutic agent encapsulated within a biocompatible polymer, and at least one therapeutic agent being disposed or encapsulated to elute from the solid drug core through the solid non-bioerodible membrane into the eye, embedding the drug delivery component into the eye and adjacent to a fluid-permeable membrane of the subject's eye, and delivering a therapeutically effective amount of at least one therapeutic agent to the eye, but not limited thereto. In certain embodiments, the delivery of the at least one therapeutic agent is for about one week to about ten years or at least about six months. In other embodiments, the fluid-permeable membrane is the lens capsule of the eye, and the drug delivery component is embedded within the lens capsule of the eye. In some embodiments, the at least one therapeutic agent is delivered through the lens capsule of the eye. In still other embodiments, a therapeutically effective amount of at least one therapeutic agent can be delivered at a sustained release rate.

[0075] In other embodiments, and further with respect to the above paragraph, the devices and methods disclosed herein include supporting the position of a drug delivery component within the eye and adjacent to a fluid-permeable membrane of the subject's eye. In some embodiments, the drug delivery component is supported in its position via an intraocular lens (IOL). In still other embodiments, the IOL can further include a haptic, and the drug delivery component includes an aperture through which the haptic is received. In other embodiments, the method includes contacting an inner surface of the fluid-permeable membrane with a portion of the drug delivery component, and optionally, the portion of the drug delivery component has a surface area greater than 4 mm 2 According to these methods, the drug delivery component includes a pad. In some embodiments, the drug delivery component includes an attachment structure coupled to the pad, and the drug delivery component is configured to couple to the intraocular lens via the attachment structure.

[0076] In one embodiment, upon insertion of the device disclosed herein, the fluid-permeable membrane for implantation can include the eye's lens capsule, and the drug delivery component can be configured to retain its shape from implantation until after the lens capsule closes over the drug delivery component disclosed herein.

[0077] In some embodiments, the fluid-permeable membrane includes the eye's lens capsule, and the drug delivery component is positioned outside the lens capsule and at least partially supported by a scaffold in the eye's sulcus. In one embodiment, the scaffold includes an intraocular lens. In other embodiments, the drug delivery component is implanted between the anterior and posterior capsule surfaces of the eye.

[0078] In some embodiments and with further reference to the above paragraph, implanting the drug delivery component into the eye can include injecting the drug delivery component into the eye via an injector, and the drug delivery component transitions from a folded orientation of the injector to an unfolded orientation within the eye.

[0079] In some embodiments, an intraocular implant for implantation into an eye of a subject can include, but is not limited to, an implant body including a scaffold, at least one haptic extending outwardly from the scaffold, and at least one haptic configured to support the position of the implant body within the eye, and a drug delivery component configured to couple to the implant body. The drug delivery component can include a solid drug core and a solid non-bioerodible membrane encapsulating the solid drug core. The solid drug core can include at least one therapeutic agent embedded within a biocompatible polymer. In some embodiments, the drug delivery component can further include an attachment structure coupled to the solid non-bioerodible membrane, and the attachment structure is configured to facilitate attachment to the implant body. In other embodiments, the attachment structure can include an aperture configured to receive a haptic of at least one haptic therethrough. In yet other embodiments, the solid non-bioerodible membrane is configured to control the elution rate of at least one therapeutic agent. In some embodiments, the elution rate is a constant daily release rate. In other embodiments, the solid non-bioerodible membrane can have a thickness of from about 15.0 microns to about 3.0 mm. In other embodiments, the solid non-bioerodible membrane includes a maximum thickness of about 3.0 mm. In yet other embodiments, the solid drug core and the solid non-bioerodible membrane can be formed within a pad having generally flat top and bottom surfaces. In one embodiment, the scaffold contemplated herein can include a lens positioned therein.

[0080] In some embodiments, and further with respect to the above paragraph

[0091] , at least one haptic can include a first haptic and a second haptic, and the first and second haptics are configured to hold the position of the intraocular implant within the capsular bag of the eye. Alternatively, in other embodiments, at least one haptic can include a first haptic and a second haptic, and the first and second haptics are configured to hold the position of the intraocular implant within the ciliary sulcus of the eye. In certain embodiments, at least one therapeutic agent can include, but is not limited to, an agent that reduces intraocular pressure, an antibiotic, an anti-inflammatory agent, a chemotherapeutic agent, an agent that promotes nerve regeneration, a steroid, an antioxidant, an anti-proliferative agent, a mitotic inhibitor, an aptamer, a complement factor, an antibody, or a pharmaceutically acceptable salt thereof, or any combination thereof.

[0081] Preferred embodiments of the apparatus and method have been described with reference to the environment in which they were developed, but they are merely illustrative of the principles of the invention. The elements of the various embodiments can be incorporated into other types respectively and the benefits of those elements can be obtained in combination with such other types, and various beneficial features can be used alone or in combination with each other in the embodiments. Other embodiments and configurations can be devised without departing from the spirit of the invention and the appended claims.

Claims

1. An intraocular implant for implantation into the eye of a target, wherein the intraocular implant is An implant body comprising a scaffold and at least one haptic extending outward from the scaffold, wherein the at least one haptic is configured to support the position of the implant body within the eye, An intraocular implant comprising a drug delivery component configured to be bonded to the implant body, the drug delivery component comprising a core and a solid non-biologically erosive membrane that completely encloses the core, wherein the core contains at least one therapeutic agent embedded in a biocompatible non-biologically erosive polymer, and the solid non-biologically erosive membrane is configured to control the elution rate as the at least one therapeutic agent elutes from the core through the solid non-biologically erosive membrane by diffusion.

2. The intraocular implant according to claim 1, wherein the drug delivery component further includes an attachment structure bonded to the solid non-biologically erosive membrane, and the attachment structure is configured to facilitate attachment to the implant body.

3. The intraocular implant according to claim 2, wherein the mounting structure comprises an opening configured to receive the haptic of at least one haptic through it.

4. The intraocular implant according to claim 1, wherein the elution rate is fixed or a constant daily release rate.

5. The intraocular implant according to claim 1, wherein the solid non-biologically erosive membrane includes a thickness of approximately 15.0 microns to approximately 2.0 mm.

6. The intraocular implant according to claim 1, wherein the solid non-biologically erosive membrane includes a thickness of up to 1.0 mm.

7. The intraocular implant according to claim 1, wherein the core and the solid non-biologically erosive membrane are formed within a pad having a generally flat top and bottom surface.

8. The intraocular implant according to claim 1, wherein the scaffold includes a lens positioned therein.

9. The intraocular implant according to claim 1, wherein the at least one haptic comprises a first haptic and a second haptic, the first and second haptics configured to hold the position of the intraocular implant within the lens capsule of the eye.

10. The intraocular implant according to claim 1, wherein the at least one haptic comprises a first haptic and a second haptic, the first and second haptics configured to hold the position of the intraocular implant within the ciliary sulcus of the eye.

11. The intraocular implant according to claim 1, wherein the at least one therapeutic agent comprises at least one of the following: an intraocular pressure lowering agent, an antibiotic, an anti-inflammatory agent, a chemotherapy agent, an agent that promotes nerve regeneration, a steroid, an antioxidant, an antiproliferative agent, a mitotic inhibitor, an aptamer, a complement factor, an antibody, or a pharmaceutically acceptable salt thereof, or any combination thereof.

12. The intraocular implant according to claim 1, wherein the at least one therapeutic agent comprises at least one of a prostaglandin analog, an α-agonist, a Rho kinase inhibitor, a tyrosine kinase inhibitor, an adenosine receptor agonist, a carbonic anhydrase inhibitor, an adrenaline and / or cholinergic receptor activator, a β-blocker, or a combination thereof.

13. The intraocular implant according to claim 1, wherein the at least one therapeutic agent comprises at least one of bimatoprost, brimonidine, latanoprost, travoprost, timolol, tafluprost, pilocarpine, brinzolamide, aflibercept, bevacizumab, pilocarpine, ethacric acid, CNP / BNP / ANP, tetrahydrocannabinol (THC), pegaptanib, ranibizumab, methotrexate, dexamethasone, triamcinolone, ketorolac, dorzolamide, prednisolone, cannabidiol (CBD), cannabinoids or other molecules derived from the cannabis plant, other agents used to treat glaucoma, macular degeneration or other eye conditions, or a combination thereof.

14. The intraocular implant according to claim 1, wherein the at least one therapeutic agent is bimatoprost, or a pharmaceutically acceptable salt thereof, or a derivative thereof.

15. The intraocular implant according to claim 1, wherein the core is a solid core.

16. The intraocular implant according to claim 1, wherein the core is a liquid composition.

17. The intraocular implant described in claim 1, At least one container, A kit that includes this.

18. The kit according to claim 17, further comprising packaging for the intraocular implant.

19. The kit according to claim 18, further comprising a system for attaching the drug delivery component to the implant body of the intraocular implant.

20. The intraocular implant according to claim 1, wherein the core is solid and maintains its shape even after the at least one therapeutic agent has eluted from the core within the target eye.

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