COMBINATION TREATMENT OF GLAUCOMA

• US 20090318549A1
• Filed: 06/24/2009
• Published: 12/24/2009
• Est. Priority Date: 06/24/2008
• Status: Abandoned Application

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: QLT Plug Delivery, Inc.
• Inventors: Butuner, Zuhal
• Application Number:
  US12/490,923
• Publication Number:
  US 20090318549A1
• Time in Patent Office: Days
• US Class Current: 514/530
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

Abstract

The methods described herein provide reduction of intraocular pressure by administering a sustained release formulation including latanoprost and a pharmaceutically acceptable vehicle and administering an eye drop adjunctive composition to the eye of a patient. The sustained release formulation can release latanoprost continuously for at least 90 days from a punctum plug delivery system. The eye drop adjunctive composition can also include latanoprost.

Claims

1. A method to reduce intraocular pressure in an eye of a patient in need thereof, the method comprising administering to the eye of the patient a sustained release formulation comprising latanoprost and a pharmaceutically acceptable vehicle and administering an eye drop adjunctive composition, wherein the sustained release formulation releases latanoprost continuously for at least 90 days from a punctum plug delivery system.

2. The method of claim 1 wherein the eye drop adjunctive composition comprises an ocular hypotensive drug selected from the group consisting of carbonic anhydrase inhibitors, beta blockers, alpha-adrenergic agents, prostaglandin analogues, miotics and epinephrine compounds.

3. The method of claim 2 wherein the eye drop adjunctive composition comprises a prostaglandin analogue.

4. The method of claim 3 wherein the prostaglandin analogue comprises latanoprost.

5. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily for less than about 10 days.

6. The method of claim 5 wherein the eye drop adjunctive composition is administered once daily for about 5 days.

7. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily starting on the same day the punctum plug delivery system is inserted into a punctum of the patient.

8. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily, starting within about four weeks after the punctum plug delivery system is inserted into a punctum of the patient.

9. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily, starting about 90 days after the punctum plug delivery system is inserted into a punctum of the patient.

10. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily, starting after removal of the punctum plug delivery system.

11. The method of claim 1 wherein the eye drop adjunctive composition is administered once daily, starting approximately five days before the punctum plug delivery system is inserted into a punctum of the patient.

12. The method of claim 1 wherein the eye drop adjunctive composition is administered after a first punctum plug delivery system is removed and before a second punctum plug delivery system is inserted into a punctum of the patient.

13. The method of claim 1 wherein the reduction in intraocular pressure is maintained for a continuous period of time selected from the group consisting of:

up to about 7 days, up to about 14 days, up to about 21 days, up to about 28 days, up to about 52 days, up to about 88 days, and up to about 105 days.

14. The method of claim 1 wherein the reduction in intraocular pressure is maintained for a continuous period of time of at least about 90 days.

15. The method of claim 13 or 14 wherein the reduction in intraocular pressure is at least about 25%.

16. The method of claim 1 wherein the intraocular pressure is reduced by at least 10% by about 1 day after latanoprost and eye drop adjunctive composition administration is initiated.

17. The method of claim 1 wherein the pharmaceutically acceptable vehicle comprises a sustained release matrix.

18. The method of claim 17 wherein the sustained release matrix is a non-biodegradable polymer.

19. The method of claim 18 wherein the non-biodegradable polymer comprises silicone.

20. The method of claim 1 wherein the punctum plug delivery system is inserted into at least one punctum of the patient.

21. The method of claim 20 wherein the punctum plug delivery system is inserted into one punctum of each of both eyes of the patient.

22. The method of claim 1 wherein the intraocular pressure is associated with ocular hypertension.

23. The method of claim 1 wherein the intraocular pressure is associated with glaucoma.

24. The method of claim 23 wherein the glaucoma is selected from the group consisting of primary open angle glaucoma, angle closure glaucoma, normal tension glaucoma and secondary glaucoma.

31. The method of claim 4 wherein the amount of latanoprost in a single drop of eye drop adjunctive composition is approximately 1.5 micrograms.

32. A kit comprising a first container comprising the punctum plug delivery system of claim 1, a second container comprising the eye drop adjunctive composition of claim 1, and instructions for use.

25. A method to treat elevated intraocular pressure comprising inserting a punctum plug delivery system into at least one punctum of a patient in need thereof and administering an eye drop adjunctive composition to an eye of the patient in need thereof, wherein the punctum plug delivery system comprises a sustained release agent supply containing about 14 micrograms of latanoprost, wherein the punctum plug delivery system remains inserted for at least about 90 days, and wherein the eye drop adjunctive composition is administered for up to about 14 days.

26. The method of claim 25, wherein the eye drop adjunctive composition is administered for about ten days.

27. The method of claim 25, wherein the eye drop adjunctive composition is administered for about five days.

28. The method of claim 25, wherein the punctum plug delivery system includes a cavity configured to house the sustained release agent supply in the form of a drug core.

29. A method to treat elevated glaucoma-associated intraocular pressure in a subject in need thereof, the method comprising:

inserting a punctum plug delivery system into at least one punctum of the subject and administering an eye drop adjunctive composition to an eye of the subject, wherein the punctum plug delivery system comprises a plug body and a latanoprost insert;

wherein the eye drop adjunctive composition comprises latanoprost;

wherein the punctum plug delivery system provides the sustained release of latanoprost to the subject; and

wherein the release of latanoprost from the punctum plug delivery system and the administration of the eye drop adjunctive latanoprost composition together result in a reduction in the intraocular pressure of the associated eye of at least 6 mm Hg.

30. A method to treat glaucoma in a subject in need thereof, the method comprising:

inserting a punctum plug delivery system into at least one punctum of the subject in a single insertion procedure and administering an eye drop adjunctive composition to the corresponding eye of the subject at least once;

wherein the eye drop adjunctive composition comprises latanoprost;

wherein the punctum plug delivery system comprises a plug body and a latanoprost insert; and

wherein the punctum plug delivery system provides the sustained release of latanoprost to the subject for at least about 90 days.