Claims for Patent: 6,551,590

Summary for Patent: 6,551,590

Title:	Hyaluronidase preparation for ophthalmic administration and enzymatic methods for accelerating clearance of hemorrhagic blood from the vireous body of the eye
Abstract:	The invention provide a method for accelerating the clearance of hemorrhagic blood from the vitreous humor of a mammalian eye without producing toxicity to the eye, the method comprising contacting with the vitreous humor an amount of a solution which contains hyaluronidase to provide a dose of at least 1 International Unit of hyaluronidase, the hyaluronidase being in purified form possessing intravitreal hemorrhage-clearing activity and being free from impurities that produce toxicity to the eye.
Inventor(s):	Karageozian; Hampar L. (San Juan Capistrano, CA), Karageozian; Vicken H. (San Juan Capistrano, CA), Kenney; Maria Cristina (Malibu, CA), Gutierrez Flores; Jose Luis (Tijuana, MX), Carpio Aragon; Gabriel Arturo (Tijuana, MX), Nesburn; Anthony B. (Malibu, CA)
Assignee:	ISTA Pharmaceuticals, Inc. (Irvine, CA)
Application Number:	09/453,012
Patent Claims:	1. A method for inducing liquefaction of a vitreous humor to treat a disorder of a mammalian eye, said method comprising: contacting with the vitreous humor of the mammalian eye an amount of a solution which contains hyaluronidase to provide a dose of at least 1 International Unit of hyaluronidase, said solution being free of thimerosal, essentially devoid of hyaluronic acid-lysing material having a molecular weight greater than 100,000 as determined by 10% SDS PAGE electrophoresis, essentially devoid of caseinolytic material having a molecular weight greater than 45,000 as determined by 15% SDS PAGE electrophoresis, and essentially devoid of gelatinolytic material having a molecular weight between 60,000 and 100,000 as determined by 10% SDS PAGE electrophoresis, and wherein said method is carried out for the purpose of accelerating the clearance of hemorrhagic blood from the vitreous humor of the mammalian eye. 2. The method of claim 1 wherein the dose of hyaluronidase is 1 International Unit. 3. The method of claim 1 wherein the dose of hyaluronidase is 1-50 International Units. 4. The method of claim 1 wherein the dose of hyaluronidase is 25-75 International Units. 5. The method of claim 1 wherein the dose of hyaluronidase is 50-200 International Units. 6. The method of claim 1 wherein the dose of hyaluronidase is 25 International Units. 7. The method of claim 1 wherein the dose of hyaluronidase is 50 International Units. 8. The method of claim 1 wherein the dose of hyaluronidase is 70 International Units. 9. The method of claim 1 wherein the dose of hyaluronidase is 200 International Units. 10. The method of claim 1 wherein the dose of hyaluronidase is 10-300 International Units. 11. The method of claim 1 wherein the contacting step is performed a single time, resulting in the contacting with the vitreous humor of a single dose of at least 1 International Unit of said hyaluronidase. 12. The method of claim 1 wherein the contacting step is performed at least twice, resulting in the contacting with the vitreous humor of at least two separate doses of said hyaluronidase, each dose being at least 1 International Unit. 13. The method of claim 1, wherein the solution which contains an amount of hyaluronidase to provide said dose comprises the ingredients hyaluronidase, lactose, and phosphate. 14. The method of claim 13, wherein the ingredients are dissolved in sterile water, sterile filtered, and lyophilized to a dry composition. 15. The method of claim 14, wherein the dry composition is dissolved in a balanced salt solution. 16. The method of claim 15 wherein the solution is a solution. 17. A method for inducing liquefaction of a vitreous humor to treat a disorder of a mammalian eye not as an adjunct to vitrectomy, said method comprising: contacting with the vitreous humor of the mammalian eye an amount of a solution which contains hyaluronidase to provide a dose of at least 1 International Unit of hyaluronidase, said solution being free of thimerosal, essentially devoid of hyaluronic acid-lysing material having a molecular weight greater than 100,000 as determined by 10% SDS PAGE electrophoresis, essentially devoid of caseinolytic material having a molecular weight greater than 45,000 as determined by 15% SDS PAGE electrophoresis, and essentially devoid of gelatinolytic material having a molecular weight between 60,000 and 100,000 as determined by 10% SDS PAGE electrophoresis, and wherein said method is carried out for the purpose of accelerating the clearance of hemorrhagic blood from the vitreous humor of the mammalian eye and wherein said contacting step is practiced in the absence of vitrectomy.

Details for Patent 6,551,590

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2015-11-22
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2015-11-22
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2015-11-22