IP Library Granted Patent US 9,504,646
Granted Patent B2
US 9,504,646 · App. 14/840,276 · Granted Nov 29, 2016

Androgen composition for treating an opthalmic condition

Inventors: John T. Trogden (Anaheim, CA); Adnan K. Salameh (Irvine, CA); Chetan P. Pujara (Irvine, CA); Anuradha V. Gore (Irvine, CA); Jaya Giyanani (Irvine, CA)
Assignee: Allergan, Inc.
A61K9/0048A61K9/00A61K31/568A61K31/569A61K31/5685A61K45/06A61K47/02A61K47/10A61K47/26A61K47/32A61K47/40A61K47/44
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Quick Facts
Patent No.
US 9,504,646
App. No.
14/840,276
Granted
Nov 29, 2016
Kind
B2
Abstract

The disclosure provides compositions for treating an ocular condition. The composition comprises a physiologically effective amount of an androgen, wherein the composition is suitable for topical administration to an eye. The disclosure further provides methods for treating an ocular condition with the disclosed compositions.

Claims (39)

1. An ophthalmic emulsion comprising testosterone in an amount of about 0.03 w/w % and castor oil, wherein the emulsion is suitable for topical administration to an eye.

2. The emulsion of claim 1 , wherein the emulsion further comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

3. The emulsion of claim 1 , further comprising an agent selected from the group consisting of an anti-inflammatory, antimicrobial, analgesic, anesthetic, lubricating agent, and a combination thereof.

4. The emulsion of claim 1 , further comprising a solubility enhancing agent.

5. A method for treating an ocular condition resulting from an androgen deficiency comprising administering the ophthalmic emulsion of claim 1 to a patient in need thereof, wherein at least one symptom of the ocular condition is alleviated.

6. The method of claim 5 , wherein the ocular condition is blepharitis.

7. The method of claim 5 , wherein the ophthalmic emulsion comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

8. The method of claim 5 , further comprising an agent selected from the group consisting of an anti-inflammatory, antibiotic, analgesic, anesthetic, lubricating agent, soothing agent, and a combination thereof.

9. The method of claim 5 , wherein symptoms associated with the ocular condition are reduced.

10. The method of claim 5 , wherein symptoms associated with the ocular condition are eliminated.

11. The method of claim 5 , wherein the administration is repeated until one or more symptoms of the ocular condition are reduced.

12. The method of claim 5 , wherein the administration is repeated until one or more symptoms of the ocular condition are eliminated.

13. The method of claim 5 , wherein the ophthalmic emulsion is administered to the eye, upper lid, lower lid, or a combination thereof.

14. An ophthalmic emulsion comprising testosterone in an amount of about 0.1 w/w % and castor oil, wherein the emulsion is suitable for topical administration to an eye.

15. The emulsion of claim 14 , wherein the emulsion further comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

16. The emulsion of claim 14 , further comprising an agent selected from the group consisting of an anti-inflammatory, antimicrobial, analgesic, anesthetic, lubricating agent, and a combination thereof.

17. The emulsion of claim 14 , further comprising a solubility enhancing agent.

18. An ophthalmic emulsion comprising testosterone in an amount of about 0.3 w/w % and castor oil, wherein the emulsion is suitable for topical administration to an eye.

19. The emulsion of claim 18 , wherein the emulsion further comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

20. The emulsion of claim 18 , further comprising an agent selected from the group consisting of an anti-inflammatory, antimicrobial, analgesic, anesthetic, lubricating agent, and a combination thereof.

21. The emulsion of claim 18 , further comprising a solubility enhancing agent.

22. A method for treating an ocular condition resulting from an androgen deficiency comprising administering the ophthalmic emulsion of claim 14 to a patient in need thereof, wherein at least one symptom of the ocular condition is alleviated.

23. The method of claim 22 , wherein the ocular condition is blepharitis.

24. The method of claim 22 , wherein the ophthalmic emulsion comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

25. The method of claim 22 , further comprising an agent selected from the group consisting of an anti-inflammatory, antibiotic, analgesic, anesthetic, lubricating agent, soothing agent, and a combination thereof.

26. The method of claim 22 , wherein symptoms associated with the ocular condition are reduced.

27. The method of claim 22 , wherein symptoms associated with the ocular condition are eliminated.

28. The method of claim 22 , wherein the administration is repeated until one or more symptoms of the ocular condition are reduced.

29. The method of claim 22 , wherein the administration is repeated until one or more symptoms of the ocular condition are eliminated.

30. The method of claim 22 , wherein the ophthalmic emulsion is administered to the eye, upper lid, lower lid, or a combination thereof.

31. A method for treating an ocular condition resulting from an androgen deficiency comprising administering the ophthalmic emulsion of claim 18 to a patient in need thereof, wherein at least one symptom of the ocular condition is alleviated.

32. The method of claim 31 , wherein the ocular condition is blepharitis.

33. The method of claim 31 , wherein the ophthalmic emulsion comprises an additional constituent selected from the group consisting of a thickener, neutralizing agent, emulsifier, buffering agent, tonicity agent, demulcent, preservative, plasticizer, occlusive agent, film former, and a combination thereof.

34. The method of claim 31 , further comprising an agent selected from the group consisting of an anti-inflammatory, antibiotic, analgesic, anesthetic, lubricating agent, soothing agent, and a combination thereof.

35. The method of claim 31 , wherein symptoms associated with the ocular condition are reduced.

36. The method of claim 31 , wherein symptoms associated with the ocular condition are eliminated.

37. The method of claim 31 , wherein the administration is repeated until one or more symptoms of the ocular condition are reduced.

38. The method of claim 31 , wherein the administration is repeated until one or more symptoms of the ocular condition are eliminated.

39. The method of claim 31 , wherein the ophthalmic emulsion is administered to the eye, upper lid, lower lid, or a combination thereof.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 2, 2015
From: TROGDEN, JOHN T.; SALAMEH, ADNAN K.; PUJARA, CHETAN P.; GORE, ANURADHA V.; GIYANANI, JAYA
To: ALLERGAN, INC.
Reel/Frame 036477/0658 →
Continuity (3)
Continuation 13357779 · Jan 25, 2012
Provisional Application 61436274 · Jan 26, 2011
Related Publication 20150366800A1 · Dec 24, 2015