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Use of hyaluronidase in the manufacture of an ophthalmic preparation for liquefying vitreous humor in the treatment of eye disorders

A hyaluronidase, vitreous humor technology, applied in metabolic diseases, sensory diseases, peptide/protein components, etc.

Inactive Publication Date: 2000-06-21
EASTA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0023] Although some hyaluronidase preparations have been reported to show desirable efficacy when injected into or topically administered to the eye, attention should be paid to hyaluronic acid in view of the safety of routine clinical administration of such preparations by intraocular injection. Potential toxicity of enzymes and / or thimerosal preservatives

Method used

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  • Use of hyaluronidase in the manufacture of an ophthalmic preparation for liquefying vitreous humor in the treatment of eye disorders
  • Use of hyaluronidase in the manufacture of an ophthalmic preparation for liquefying vitreous humor in the treatment of eye disorders
  • Use of hyaluronidase in the manufacture of an ophthalmic preparation for liquefying vitreous humor in the treatment of eye disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] 52 healthy New Zealand Cross Variety rabbits (26 male rabbits, 26 female rabbits) weighing 1.5-2.5 kg were marked with identification marks and kept in hanging cages respectively. Rabbits were provided with a daily basal amount of commercial rabbit chow bolus and ad libitum access to tap water.

[0085] Rabbits were divided into 13 groups of 4 (2 males, 2 females). In each group, 2 rabbits (1 male, 1 female) were selected for fundus photography and fluorescein angiography pretreatment.

[0086] Fundus photography was carried out as follows: rabbits were fixed, and KOWA with Kodak Gold 200 ASA film was used  The RC-3 fundus camera takes pictures of the optic nerve and retinal arch.

[0087] Fluorescein angiography involves injecting 1.5 ml of 2% sterile fluorescein solution via the marginal ear vein. About 30 seconds after injection, fluorescein develops in the optic nerve, retinal blood vessels and fundus.

[0088] The next day, each rabbit was anesthetized with an...

Embodiment 2

[0106] In this example, 12 healthy new acyl hybrid rabbits were marked with identification marks and kept in hanging cages. Rabbits were provided with a daily basal amount of commercial rabbit chow bolus and ad libitum access to tap water.

[0107] Rabbits were randomly divided into 4 treatment groups with 3 rabbits in each group.

[0108] First, the pupils of each rabbit's eyes were dilated with 1-2 drops of 10% tropicamide, followed by visual inspection, indirect ophthalmoscopy with a 20 diopter lens, and slit-lamp examination of the anterior chamber of the eye.

[0109] After the initial examination of the eyes of the rabbits, a 100:1 or 10:1 blood injection was injected into the vitreous of each eye of each rabbit.

[0110] On day 2, BSS or hyaluronidase ACS was injected into the vitreous of the right eye of each treatment group rabbit according to the following treatment schedule, where each rabbit received one injection: Group # Treatment

[0111] ...

Embodiment 3

[0120] The main objective of this study was to determine whether a balanced salt solution containing highly purified hyaluronidase extracted from bovine testicular tissue could be injected into the vitreous of visually impaired eyes without causing any serious ocular side effects. Test materials and methods

[0121] Balanced salt solution (BSS) obtained from Allergan Pharmaceutical (Irvine, CA) was used as a placebo. BSS contains 0.64% sodium chloride, 0.075% potassium chloride, 0.048% calcium chloride dihydrate, 0.03% magnesium chloride hexahydrate, 0.39% sodium acetate trihydrate, enough sodium hydroxide to adjust the pH to 7.1-7.2 / hydrochloric acid, and water for injection (appropriate amount 100%). A 30 microliter aliquot of BSS or Hyaluronidase Specific Formulation D (Table 6) was filled in a 300 microsyringe fitted with a 0.5 inch long 29 gauge needle. The sample is then injected into the vitreous of the patient's eye using a microsyringe containing the injected samp...

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Abstract

An enzymatic method is provided for treating ophthalmic disorders of the mammalian eye. Prevention of neovascularization and the increased rate of clearance from the vitreous of materials toxic to retina is accomplished by administering an amount of hyaluronidase effective to liquefy the vitreous humor of the treated eye without causing toxic damage to the eye. Liquefaction of the vitreous humor increases the rate of liquid exchange from the vitreal chamber. This increase in exchange removes those materials and conditions whose presence causes ophthalmological and retinal damage.

Description

technical field [0001] This invention relates generally to enzyme preparations for administration to the eye of a human or other mammal, and more particularly to the use of one or more enzymes for the treatment of ophthalmic diseases affecting the retina and / or vitreous humor of the eye of a mammal method. Background technique [0002] Anatomy of the human eye [0003] In humans, the anatomy of the eye includes the "vitreous body," which sits behind the lens and occupies approximately four-fifths of the eye cavity. The vitreous body is made of a jelly-like substance called vitreous humor. In general, the vitreous humor of a normal human eye contains about 99% of water and 1% of macromolecules, including: collagen, hyaluronic acid, soluble glycoproteins, sugars and other low molecular weight metabolites. [0004] The retina is basically a layer of nerve tissue that forms on the inner back surface of the eyeball. The retina is...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/46A61K38/47A61P3/10A61P27/02
CPCA61K38/47A61P3/10A61P27/02
Inventor H·L·卡拉格奥兹安V·H·卡拉格奥兹安M·C·肯尼J·L·G·弗洛雷斯G·A·C·阿拉贡A·B·内斯布恩
Owner EASTA PHARMA
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