SUSTAINED RELEASE DELIVERY OF ACTIVE AGENTS TO TREAT GLAUCOMA AND OCULAR HYPERTENSION

• US 20090280158A1
• Filed: 05/08/2009
• Published: 11/12/2009
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: QLT Plug Delivery, Inc.
• Inventors: Butuner, Zuhal
• Granted Patent: US 9,949,942 B2
• Time in Patent Office: Days
• US Class Current: 424/428
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• 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 treatment of glaucoma, ocular hypertension, and elevated intraocular pressure with latanoprost or other therapeutic agent(s). Implant devices for insertion into a punctum of a patient provide sustained release of latanoprost or other therapeutic agent(s) that is maintained for 7, 14, 21, 30, 45, 60, or 90 days or more, thus avoiding patient noncompliance and reducing or lowering adverse events associated with eye drop administration of latanoprost or other therapeutic agent(s) and other therapeutic agent(s).

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 topical formulation comprising an intraocular pressure-reducing therapeutic agent, wherein the intraocular pressure-reducing therapeutic agent is capable of being continuously released over time to the eye and wherein the intraocular pressure is reduced at least 10% from baseline.

2. The method of claim 1, wherein the intraocular pressure is reduced an amount selected from the group consisting of at least 15% from baseline, at least 20% from baseline, and at least 25% from baseline.

3. The method of claim 1, wherein the intraocular pressure-reducing therapeutic agent is released for a period of time selected from the group consisting of at least about 30 days, at least about 60 days, and at least about 90 days.

4. The method of claim 1, wherein the intraocular pressure-reducing therapeutic agent is an anti-glaucoma drug.

5. The method of claim 4, wherein the anti-glaucoma drug is selected from the group consisting of an adrenergic agonist, an adrenergic antagonist, a beta blocker, a carbonic anhydrase inhibitor, a parasympathomimetic, a prostaglandin analog, a hypotensive lipid, a neuroprotectant, and combinations thereof.

6. The method of claim 5, wherein the anti-glaucoma drug is latanoprost.

7. The method of claim 1, wherein the formulation is disposed in and eluted from an ocular implant.

8. The method of claim 7, wherein the ocular implant comprises a punctal implant.

9. The method of claim 8, wherein the formulation is impregnated within the punctal implant such that at least one surface of the implant is coated with the formulation.

10. The method of claim 8, wherein the formulation is contained within a sustained release core disposed in the punctal implant.

11. The method of claim 8, wherein the punctal implant contains an amount of intraocular pressure-reducing therapeutic agent selected from the group consisting of about 3.5 micrograms, about 14 micrograms, about 21 micrograms and about 44 micrograms.

12. The method of claim 8, wherein the punctal implant is inserted into one punctum of each of both eyes of the patient.

13. The method of claim 1, wherein the formulation is administered approximately once every 90 days, and wherein the intraocular pressure-reducing therapeutic agent is continuously released to the eye for a period of time selected from the group consisting of approximately 180 days, approximately 270 days, approximately 360 days, approximately 450 days, approximately 540 days, approximately 630 days, approximately 720 days, approximately 810 days and approximately 900 days.

14. The method of claim 1, wherein between about 25 ng/day and about 250 ng/day of the intraocular pressure-reducing therapeutic agent is released.

15. The method of claim 1, wherein the intraocular pressure is at least about 20 mm Hg before administering the intraocular pressure-reducing therapeutic agent.

16. 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 56 days, up to about 84 days, and up to about 105 days.

17. The method of claim 1 wherein patient noncompliance is significantly reduced compared to eye drop formulations of intraocular pressure-reducing therapeutic agents.

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

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

20. A method to reduce intraocular pressure in an eye of a patient in need thereof, comprising inserting an implant into at least one punctum of the eye wherein the implant comprises a sustained release core comprising an intraocular pressure-reducing agent, wherein the intraocular pressure-reducing therapeutic agent is capable of being continuously released over time to the eye, and wherein the intraocular pressure is reduced at least about 10% from baseline.

21. The method of claim 20, wherein the intraocular pressure is reduced an amount selected from the group consisting of at least 15% from baseline, at least 20% from baseline and at least 25% from baseline.

22. The method of claim 20, wherein the intraocular pressure-reducing therapeutic agent is released for a period of time selected from the group consisting of at least about 30 days, at least about 60 days, and at least about 90 days.

23. The method of claim 20, wherein the sustained release core is disposed in an implant body.

24. The method of claim 20, wherein the patient is suffering from glaucoma.

25. The method of claim 20, wherein at least one of the implant or the sustained release core is at least partially coated by an impermeable coating.

26. The method of claim 25, wherein the impermeable coating comprises parylene.

27. The method of claim 20, wherein the intraocular pressure-reducing therapeutic agent comprises latanoprost.