Sustained release delivery of active agents to treat glaucoma and ocular hypertension

• US 9,949,942 B2
• Filed: 05/08/2009
• Issued: 04/24/2018
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: Mati Therapeutics, Inc
• Inventors: Butuner, Zuhal
• Primary Examiner(s): Duffy, Patricia
• Assistant Examiner(s): Gotfredson, Garen
• Application Number:
  US12/463,279
• Publication Number:
  US 20090280158A1
• Time in Patent Office: 3,273 Days
• Field of Search: None
• 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 having open angle glaucoma or ocular hypertension and a baseline intraocular pressure of 21-30 mmHg, the method comprising:

administering to the eye of the patient having open angle glaucoma or ocular hypertension and a baseline intraocular pressure of 21-30 mmHg, an intraocular pressure-reducing therapeutic agent sustained release topical formulation, wherein the sustained release topical formulation is capable of continuously releasing the intraocular pressure-reducing therapeutic agent over at least 7 days to the eye from a punctal implant wherein the intraocular pressure is reduced at least 10% from baseline, and

wherein the punctal implant comprises a first, second and intermediate portion, wherein the implant extends from a proximal end of the first portion, defining a proximal axis, to a distal end of the second portion, defining a distal axis, and when implanted, is configured with an at least 45 degree angled intersection between the proximal axis and the distal axis for biasing at least a portion of the implant against at least a portion of a lacrimal canaliculus located at or more distal to a canaliculus curvature and wherein the intermediate portion projects proximally from the intersection between the first and second implant body portions and is configured to bias against a portion of a lacrimal canaliculus ampulla.

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 formulation is dispersed throughout a body of the punctal implant.

5. The method of claim 1, wherein the formulation is contained within a drug core disposed in the punctal implant, wherein the drug insert comprises a matrix and therapeutic agent.

6. The method of claim 1, wherein the punctal implant is inserted into one punctum of each of both eyes of the patient.

7. 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 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.

12. The method of claim 4, wherein the punctal implant is at least partially coated by an impermeable coating.

13. The method of claim 12, wherein the impermeable coating is parylene.

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

15. The method of claim 1, wherein the intraocular pressure-reducing therapeutic agent is bimatoprost, latanoprost, or travoprost.

8. A method to reduce intraocular pressure in an eye of a patient having open angle glaucoma or ocular hypertension and a baseline intraocular pressure of 21-30 mmHg, the method comprising:

inserting a punctal implant into at least one punctum of the eye of the patient having open angle glaucoma or ocular hypertension and a baseline intraocular pressure of 21-30 mmHg, wherein the implant comprises an intraocular pressure-reducing therapeutic agent sustained release topical formulation drug core comprising a matrix and the therapeutic agent, wherein the sustained release topical formulation is capable of continuously releasing the intraocular pressure-reducing therapeutic agent over at least 7 days to the eye wherein the intraocular pressure is reduced at least about 10% from baseline, and

wherein the punctal implant comprises a first, second and intermediate portion, wherein the implant extends from a proximal end of the first portion, defining a proximal axis, to a distal end of the second portion, defining a distal axis, and when implanted, is configured with an at least 45 degree angled intersection between the proximal axis and the distal axis for biasing at least a portion of the implant against at least a portion of a lacrimal canaliculus located at or more distal to a canaliculus curvature and wherein the intermediate portion projects proximally from the intersection between the first and second implant body portions and is configured to bias against a portion of a lacrimal canaliculus ampulla.

9. The method of claim 8, wherein the intraocular pressure is reduced by an amount selected from the group consisting of at least 15% from baseline, at least 20% from baseline and at least 25% from baseline.

10. The method of claim 8, 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.

11. The method of claim 8, wherein the punctal implant comprises a retention structure.

16. The method of claim 8, wherein the intraocular pressure-reducing therapeutic agent is an anti-glaucoma medication.

17. The method of claim 8, wherein the intraocular pressure-reducing therapeutic agent is bimatoprost, latanoprost, or travoprost.

18. The method of claim 8, wherein the matrix of the drug core is selected from silicone, acrylate, polyethylene, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra-high molecular weight polyethylene, polycarbonate urethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, or cobalt-chrome alloy.