US2006034822A1PendingUtilityA1

Hyaluronidase preparation for ophthalmic administration and enzymatic methods for accelerating clearance of hemorrhagic blood from the vitreous body of the eye

Individually held — no corporate assignee on recordPriority: Nov 22, 1995Filed: Aug 15, 2005Published: Feb 16, 2006

Est. expiryNov 22, 2015(expired)· nominal 20-yr term from priority

Inventors:Hampar L. Karageozian Vicken H. Karageozian Maria Kenney Jose Luis Gutierrez Flores Gabriel Arturo Carpio Aragon Anthony B. Nesburn

A61K 31/7016A61P 27/00A61P 27/02A61K 38/47A61K 38/43

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References

Claims

Abstract

A thimerosal-free hyaluronidase preparation wherein the preferred hyaluronidase enzyme is devoid of molecular weight fractions below 40,000 MW, between 60-70,000 MW and above 100,000 MW. Also disclosed is a method for accelerating the clearance of hemorrhagic blood from the vitreous humor of the eye, said method comprising the step of contacting at least one hemorrhage-clearing enzyme (e.g., a β-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.

Claims

exact text as granted — not AI-modified

1 . A method for accelerating the clearance of hemorrhagic blood from the vitreous humor of a mammalian eye, said method comprising the step of:
contacting with said vitreous humor an amount of an enzyme which is active to accelerate the clearance of hemorrhagic blood from the vitreous humor.

2 . The method of claim 1 wherein said enzyme is selected from the group consisting of:
hyaluronidase; keratinase; chondroitinase AC; chondroitinase B; chondroitinase ABC; chondroitin 4 sulfatase; chondroitin 6 sulfatase; matrix metalloproteinase-1; matrix metalloproteinase-2; matrix metalloproteinase-3; matrix metalloproteinase-9; streptokinase; urokinase; and, combinations thereof.

3 . The method of claim 1 wherein said enzyme is a β-glucuronidase enzyme.

4 . The method of claim 1 wherein said enzyme is a matrix metalloproteinase enzyme.

5 . The method of claim 1 wherein said enzyme is a protein kinase enzyme.

6 . The method of claim 1 wherein said enzyme is a chondroitin sulfatase enzyme.

7 . The method of claim 1 wherein said enzyme is in liquid solution, and wherein the step of contacting of said enzyme with the vitreous humor comprises:
injecting said liquid solution into the vitreous humor.

8 . The method of claim 1 wherein said enzyme is hyaluronidase.

9 . The method of claim 8 wherein said amount of said hyaluronidase enzyme is 10-300 International Units.

10 . The method of claim 1 wherein said enzyme is administered in a single intravitreal injection.

11 . The method of claim 10 herein the single intravitreal injection has an injectate volume of less than 50 μl.

12 . The method of claim 8 wherein said hyaluronidase enzyme is devoid of molecular weight fractions above 100,000 MW.

13 . The method of claim 8 wherein said hyaluronidase is devoid of hyaluronidase molecular weight fractions below 40,000 MW.

14 . The method of claim 8 wherein said hyaluronidase is devoid of molecular weight fractions between 60,000-70,000 MW.

15 . The method of claim 8 wherein said hyaluronidase is devoid of molecular weight fractions above 100,000 MW below 40,000 MW and between 60,000-70,000 MW.

16 . The method of claim 8 wherein hyaluronidase enzyme is devoid of gelatinolytic hyaluronidase having molecular weights between approximately 60,000-100,000 MW.

17 . The method of claim 8 wherein said hyaluronidase enzyme is devoid of caseinolytic hyaluronidase having molecular weight above approximately 45,000 MW.

18 . The method of claim 8 wherein said hyaluronidase enzyme is devoid of hyaluronic acid lysing hyaluronidase having molecular weights above approximately 100,000 MW.

19 . The method of claim 1 wherein said method further comprises:
contacting said enzyme with said vitreous humor in the absence of thimerosal.

20 . The method of claim 8 wherein said hyaluronidase enzyme is prepared in a solution for injection which is free of thimerosal and which has the general formulation:

Hyaluronidase (ACS)
0-8000 I.U.;

Lactose, USP
13.3 mg; and

Phosphate, USP
5 mmoles;

and, wherein the hyaluronidase enzyme is devoid of molecular weight fractions below 40,000.

21 . The method of claim 20 wherein said solution for injection has the following specific formulation:

Hyaluronidase (ACS)
7,200 I.U.;

Lactose, USP
13.3 mg; and

Phosphate, USP
5 mmoles.

22 . The method of claim 20 wherein said solution for injection is dissolved in balanced salt solution.

23 . A hyaluronidase preparation for ophthalmic administration, said preparation being free of thimerosal and free of hyaluronidase which is less than 40,000 MW.

24 . The preparation of claim 23 wherein said preparation is further free of hyaluronidase having molecular weights between 60,000-70,000 MW.

25 . The preparation of claim 23 wherein said preparation is further free of hyaluronidase having a molecular weight in excess of 100,000 MW.

26 . The preparation of claim 23 wherein said preparation is further devoid of hyaluronic acid lysing hyaluronidase having molecular weight above approximately 100,000 MW.

27 . The preparation of claim 23 wherein said preparation is further devoid of caseinolytic hyaluronidase having molecular weight above approximately 45,000 MW.

28 . The preparation of claim 23 wherein said preparation is further devoid of gelatinolytic hyaluronidase having molecular weight between approximately 60,000-100,000 MW.

29 . The preparation of claim 23 wherein said preparation is a solution for injection having the following general formulation:

Hyaluronidase (ACS)
0-8000 I.U.;

Lactose, USP
13.3-133.3 mg; and

Phosphate, USP
5-200 mmoles;

and, wherein the hyaluronidase enzyme is devoid of molecular weight fractions below 40,000.

30 . The preparation of claim 29 wherein the amount of hyaluronidase (ACS) in said formulation is 7,200 I.U.

31 . The preparation of claim 29 wherein the components of said formulation are dissolved in balanced salt solution.

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