INTRACAMERAL SUSTAINED RELEASE THERAPEUTIC AGENT IMPLANTS

• US 20110182966A1
• Filed: 01/21/2011
• Published: 07/28/2011
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Robinson, Michael R., Schiffman, Rhett M., Burke, James A.
• Granted Patent: US 8,647,659 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

Abstract

Described herein are intracameral implants including at least one therapeutic agent for treatment of at least one ocular condition. The implants described herein are not anchored to the ocular tissue, but rather are held in place by currents and gravity present in the anterior chamber of an eye. The implants are preferably polymeric, biodegradable and provide sustained release of at least one therapeutic agent to both the trabecular meshwork and associated ocular tissue and the fluids within the anterior chamber of an eye.

Claims

1. A method for treating an ocular condition comprising the steps of:

providing at least two biodegradable sustained release implants containing at least one therapeutic agent;

implanting the at least two biodegradable sustained release implants into the anterior chamber of an eye; and

treating the ocular condition,

wherein the at least two biodegradable sustained release implants release about 100 ng per day of the at least one bioactive agent for a period greater than about 1 month.

2. The method according to claim 1 wherein the ocular condition is glaucoma.

3. The method according to claim 1 wherein the ocular condition is elevated intraocular pressure.

4. The method according to claim 1 wherein the sustained release implant releases about 70% of the at least one therapeutic agent over the first month.

5. The method according to claim 1, wherein the at least one therapeutic agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.

6. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent.

7. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 70% poly(D,L-lactide).

8. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 40% poly(DL-lactide-co-glycolide).

9. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 5% to about 40% polyethylene glycol.

10. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent, 65% poly(D,L-lactide), and 5% polyethylene glycol.

11. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent, 65% poly(D,L-lactide), and 5% polyethylene glycol.

12. The method according to claim 1 wherein the at least two biodegradable sustained release implants comprise about 20% therapeutic agent, 55% poly(D,L-lactide), 10% poly(DL-lactide-co-glycolide), and 5% polyethylene glycol.

13. The method according to claim 1 wherein the implanting step is accomplished using an applicator.

14. The method according to claim 1 wherein the at least two biodegradable sustained release implants are settled out in the inferior angle within 24 hours of implanting within the anterior chamber.

15. A method for treating glaucoma in an eye comprising the steps of:

providing at least two biodegradable sustained release implants containing at least one therapeutic agent;

implanting the at least two biodegradable sustained release implants into the anterior chamber of the eye;

allowing a sufficient time for the at least two biodegradable sustained release implants to settled out in the inferior angle;

allowing a sufficient time for the at least two biodegradable sustained release implants to release the at least one therapeutic agent; and

treating glaucoma,

wherein the at least two biodegradable sustained release implants release about 100 ng per day of the at least one bioactive agent for a period greater than about 1 month.

16. The method according to claim 15 wherein the sufficient time for the at least two biodegradable sustained release implants to release the at least one therapeutic agent is greater than about 42 days.

17. The method according to claim 15, wherein the at least one therapeutic agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.

18. The method according to claim 15 wherein the at least two biodegradable sustained release implants comprise about 30% therapeutic agent, 65% poly(D,L-lactide), and 5% polyethylene glycol.

19. The method according to claim 15 wherein the at least two biodegradable sustained release implants comprise about 20% therapeutic agent, 55% poly(D,L-lactide), 10% poly(DL-lactide-co-glycolide), and 5% polyethylene glycol.

20. The method according to claim 15 wherein the sufficient time for the at least two biodegradable sustained release implants to settled out in the inferior angle is about 24 hours.