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

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

RELATED APPLICATIONS [0001] This application is a continuation and claims the benefit of priority of U.S. patent application Ser. No. 10 / 371,850 filed Feb. 21, 2003, now U.S. Pat. No. ______, which is a continuation and claims the benefit of priority of U.S. patent application Ser. No. 09 / 444,003 filed Nov. 19, 1999, now U.S. Pat. No. 6,610,292, which is a continuation of and claims the benefit of priority of International Appl. No. PCT / US98 / 10578 filed May 22, 1998, designating the United States of America and published in English, which is a continuation-in-part and claims the benefit of priority of U.S. patent application Ser. No. 08 / 862,620 filed May 22, 1997, now abandoned, which is a continuation-in-part and claims the benefit of priority of U.S. patent application Ser. No. 08 / 561,636 filed Nov. 22, 1995, now U.S. Pat. No. 5,866,120, all of which are hereby expressly incorporated by reference in their entireties.FIELD OF THE INVENTION [0002] The present invention relates gener...

AI Technical Summary

Benefits of technology

"The patent describes a method for treating ophthalmic disorders by using an enzyme called hyaluronidase to liquefy the vitreous humor of the eye. This helps to remove materials that can cause damage to the retina. The treatment is safe and effective, and can be used to treat various disorders such as diabetic retinopathy, age-related macular degeneration, and cystoid macular edema. The hyaluronidase is administered in a liquid solution and does not cause any harm to the eye. The patent also describes a formulation of the hyaluronidase for injection that is free of certain ingredients and has a specific concentration. Overall, the patent provides a technical solution for treating ophthalmic disorders by liquefying the vitreous humor."

Problems solved by technology

Such necrosis of the photoreceptor cells of the retina may result in loss of vision.

Furthermore, allowing the retinal detachment to remain unrepaired for such extended period of time may result in further vitreous hemorrhage and / or the formation of fibrous tissue at the site of the hemorrhage.

Such formation of fibrous tissue may result in the formation of an undesirable permanent fibrous attachment between the vitreous body and the retina.

However, in view of the potential complications which may result from delayed diagnosis or treatment of a retinal tear or detachment, it is generally not desirable to wait for such natural clearance of the hemorrhagic blood to occur.

Furthermore, even when the vitreous hemorrhage is not accompanied by retinal tear or detachment, it is often difficult to verify that retinal tear or detachment has not occurred, because the clouded vitreous prevents the physician from performing routine funduscopic examination of the retina.

Moreover, the presence of hemorrhagic blood within the vitreous may significantly impair or completely obscure the patient's vision through the affected eye, and will continue to do so until such time as the hemorrhagic blood has been substantially or fully cleared.

Thus, the presence of hemorrhagic blood within the vitreous body causes multiple clinical problems including a) inability to visually examine and diagnose the site and cause of the hemorrhage and / or any accompanying tear or detachment of the retina, b) full or partial impairment of vision in the affected eye, and c) impairment or prevention of the performance of trans-vitreal surgical procedures of the type of treatment typically utilized to repair the site of hemorrhage and / or to repair any accompanying retinal tear or detachment.

Such vitrectomy procedures are highly skill intensive, and are associated with several significant drawbacks, risks and complications.

Among these drawbacks, risks and complications are the potential that the act of removing the vitreous will cause further detachment or tearing of the retina and / or that such removal of the vitreous will cause further hemorrhage from the already weakened retinal blood vessels.

Unfortunately, it has not been previously known whether the reported therapeutic activities and toxicities of hyaluronidase are universally applicable to all hyaluronidase preparations, or whether such efficacies and / or toxicities are applicable only to hyaluronidase preparations containing certain excipient materials or to hyaluronidase enzymes derived from specific sources.

Although some hyaluronidase preparations have been reported to exhibit desirable therapeutic effects when injected into or administered topically to the eye, the potential toxicities of hyaluronidase and / or the thimerosal preservative are cause for concern regarding the safety of routine clinical administration of such preparations by intraocular injection.

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