IP Library Granted Patent US 11,419,886
Granted Patent B2
US 11,419,886 · App. 17/534,349 · Granted Aug 23, 2022

Formulations and methods for treating conditions of the eye

Inventors: Paul Badawi (Atherton, CA); David Y. Badawi (Glenview, IL)
Assignee: SIGHT SCIENCES, INC.
A61K31/7052A61K9/0048A61K31/194A61K47/10A61P27/04
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Quick Facts
Patent No.
US 11,419,886
App. No.
17/534,349
Granted
Aug 23, 2022
Kind
B2
Abstract

The present disclosure relates to methods of treating chronic conditions of the eye, such as dry eye disease and blepharitis, as well as to methods for increasing secretion of meibum. This disclosure also relates to formulations suitable for treating chronic conditions of the eye such as dry eye disease and blepharitis.

Claims (38)

1. A method for treating dry eye disease comprising:

administering to an external surface of an upper eyelid above an upper lid margin a pharmaceutical formulation comprising:

a) between about 1% and about 20% azelaic acid; and

b) between about 0.1% and about 0.5% azithromycin,

wherein the pharmaceutical formulation is administered to the external surface of the upper eyelid daily for at least 1 month, and wherein administering the pharmaceutical formulation reduces a symptom of the dry eye disease.

2. The method of claim 1 , wherein the symptom of dry eye disease is meibomian gland dysfunction, redness, stinging, burning, itching, light sensitivity, watery eyes, blurry vision, irregularities of the ocular surface, or damage to corneal or conjunctival epithelium and tissues.

3. The method of claim 1 , wherein the dry eye disease is aqueous tear-deficient dry eye (ADDE).

4. The method of claim 1 , wherein the dry eye disease is evaporative dry eye (EDE).

5. The method of claim 1 , wherein ADDE and EDE are treated simultaneously.

6. The method of claim 1 , wherein the administration of said pharmaceutical formulation further reduces a symptom of blepharitis.

7. The method of claim 6 , wherein the blepharitis is anterior blepharitis.

8. The method of claim 6 , wherein the blepharitis is posterior blepharitis.

9. The method of claim 6 , wherein the blepharitis is both anterior blepharitis and posterior blepharitis.

10. The method of claim 1 , wherein the administration of said pharmaceutical formulation further improves the amount or quality of meibum produced.

11. The method of claim 1 , wherein the dry eye disease does not result from bacterial infection, parasitic infection, or inflammation of tissue.

12. The method of claim 1 , wherein the concentration of azelaic acid is between about 5% and 20%.

13. The method of claim 1 , wherein the concentration of azelaic acid is between about 5% and 15%.

14. The method of claim 1 , wherein the concentration of azelaic acid is between about 5% and 15% and the concentration of azithromycin is between about 0.4% and about 0.5%.

15. The method of claim 1 , wherein the concentration of azelaic acid is about 10% and the concentration of azithromycin is about 0.4%.

16. The method of claim 1 , wherein the pharmaceutical formulation is administered twice daily.

17. The method of claim 1 , wherein the pharmaceutical formulation is administered daily for at least 6 months.

18. The method of claim 1 , wherein the pharmaceutical formulation is administered daily for at least 1 year.

19. The method of claim 1 , wherein the pharmaceutical formulation is administered as a cream, gel, suspension, solution, ointment, or spray.

20. The method of claim 19 , wherein the pharmaceutical formulation is administered as a cream.

21. The method of claim 19 , wherein the pharmaceutical formulation is administered as a gel.

22. The method of claim 1 , wherein the pharmaceutical formulation further comprises at least one skin penetration enhancer.

23. The method of claim 1 , wherein the pharmaceutical formulation further comprises at least one polyol.

24. The method of claim 23 , wherein the at least one polyol is propylene glycol, polyethylene glycol, glycerol, erythritol, mannitol, or sorbitol.

25. The method of claim 24 , wherein the at least one polyol is propylene glycol.

26. The method of claim 1 , wherein the concentration of azelaic acid is between about 10% and 15%.

27. The method of claim 1 , wherein the pharmaceutical formulation is applied to the external surface of the upper eyelid and to an external surface of a lower eyelid.

28. A method for treating dry eye disease comprising:

administering to an external surface of an eyelid above upper lashes a pharmaceutical formulation comprising:

a) between about 1% and about 20% azelaic acid; and

b) between about 0.1% and about 0.5% azithromycin,

wherein the pharmaceutical formulation is administered to the external surface of the upper eyelid daily for at least 1 month, and wherein administering the pharmaceutical formulation reduces a symptom of the dry eye disease.

29. The method of claim 28 , wherein the pharmaceutical formulation comprises between about 5% and about 20% azelaic acid.

30. The method of claim 28 , wherein the pharmaceutical formulation is applied to the external surface of the upper eyelid above the upper lashes and to an external surface of a lower eyelid below the lower lashes.

Assignments (2)
SECURITY INTEREST Recorded Jan 23, 2024
From: SIGHT SCIENCES, INC.
To: HERCULES CAPITAL, INC., AS AGENT
Reel/Frame 066364/0162 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 29, 2022
From: BADAWI, PAUL; BADAWI, DAVID Y.
To: SIGHT SCIENCES, INC.
Reel/Frame 059717/0504 →
Cited By (4)
US 12,310,891 US 12,350,192 US 12,589,024 US 12,589,025