Claims for Patent: 6,039,943

Summary for Patent: 6,039,943

Title:	Method for accelerating clearance of hemorrhagic blood from the vitreous body with hyaluronidase
Abstract:	A thimerosal-free hyaluronidase is prepared wherein the preferred hyaluronidase is devoid of molecular weight fractions below 40,000 MW, between 60-70,000 MW and above 100,000 MW. Also a method for accelerating the clearance of hemorrhagic blood from the vitreous humor of the eye is carried out by contacting at least one hemorrhage-clearing enzyme (e.g., hyaluronidase, .beta.-glucuronidase, matrix metalloproteinase, chondroitinase, chondroitin sulfatase or protein kinase) with the vitreous humor in an amount which is effective to cause accelerated clearance of blood therefrom.
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:	Advanced Corneal Systems (Irvine, CA)
Application Number:	09/139,282
Patent Claims:	1. A method for accelerating the clearance of hemorrhagic blood from the vitreous humor of a mammalian eye, said 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, said solution being: i) free of thimerosal; ii) essentially devoid of hyaluronic acid-lysing material having a molecular weight greater than 100,000; iii) essentially devoid of caseinolytic material having a molecular weight greater than 45,000; and iv) essentially devoid of gelatinolytic material having a molecular weight between 60,000 and 100,000. 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 32 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 13 wherein the solution is a solution for injection. 17. A method for accelerating the clearance of hemorrhagic blood from the vitreous humor of a mammalian eye not as an adjunct to vitrectomy, said 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 not as an adjunct to vitrectomy, said solution being: i) free of thimerosal; ii) essentially devoid of hyaluronic acid-lysing material having a molecular weight greater than 100,000; iii) essentially devoid of caseinolytic material having a molecular weight greater than 45,000; and iv) essentially devoid of gelatinolytic material having a molecular weight between 60,000 and 100,000.

Details for Patent 6,039,943

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
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2015-11-22
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2015-11-22