Drug delivery devices for delivery of ocular therapeutic agents

• US 8,765,166 B2
• Filed: 07/22/2013
• Issued: 07/01/2014
• Est. Priority Date: 05/17/2010
• Status: Active Grant

• Current Assignee: Novaer Holdings, Inc.
• Original Assignee: Novaer Holdings, Inc.
• Inventors: Kopczynski, Casey, Lin, Cheng-Wen, Sutay, Chris
• Primary Examiner(s): PACKARD, BENJAMIN J
• Application Number:
  US13/947,564
• Publication Number:
  US 20130317458A1
• Time in Patent Office: 344 Days
• Field of Search: 424/427
• US Class Current: 424/427
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• 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
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Drug delivery devices comprising a non-bioabsorbable polymer structure configured to support a composition comprising an active agent. The devices include a plurality of portions fused together and a recess configured to support the composition. At least one of the portions includes an impermeable polymer and at least one other portion includes a rate-limiting water-permeable polymer. The rate-limiting water-permeable polymer allows for transportation of the active agent to an exterior of the device.

Claims

1. A device for insertion in the eye comprising:

a composition in the form of a matrix of an active agent and a non-water soluble polymer, wherein the active agent is selected from the group consisting of latanoprost free acid salt, travoprost free acid salt, bimatoprost free acid salt, and tafluprost free acid salt;

a first polymer portion;

a second polymer portion fused to the first polymer portion, the second polymer portion including a recess configured to support the composition; and

a third polymer portion fused to the second polymer portion,

wherein the total thickness of the device ranges from 20 μ

m to 500 μ

m, and

wherein the device is configured to;

(a) conform to a curvature of the eye,

(b) yield an elution rate of 0.00025-0.0075 micrograms/hr of the active agent, and

(c) release 70% to 90% of the active agent over a period of at least 30 days.

2. The device of claim 1, wherein the first polymer portion, the second polymer portion, and the third polymer portion is selected from the group consisting of:

ethylene vinyl acetate with a vinyl acetate content from 10% to 50% by weight (EVA-10-50) and ethylene vinyl alcohol with a vinyl alcohol content from 40% to 80% by weight (EVOH40-80).

3. The device of claim 1, wherein the active agent is latanoprost free acid salt.

4. The device of claim 1, wherein the device is substantially cylindrical-shaped.

5. The device of claim 1, wherein the first polymer portion, the second polymer portion, and the third polymer portion are manufactured from the same polymer.

6. The device of claim 1, wherein the first polymer portion, the second polymer portion, and the third polymer portion are manufactured from a non-water soluble polymer.

7. The device of claim 6, wherein the non-water soluble polymer is ethylene vinyl acetate having a vinyl acetate content of from 9% to 50% by weight.

8. The device of claim 7, wherein the ethylene vinyl acetate content in the first polymer portion, the second polymer portion, and the third polymer portion are the same.

9. The device of claim 7, wherein the ethylene vinyl acetate content in the first polymer portion, the second polymer portion, and the third polymer portion are different.

10. The device of claim 1, wherein the non-water soluble polymer of the composition is ethylene vinyl acetate having a vinyl acetate content of from 9% to 50% by weight.

11. A method of treating an ocular condition comprising inserting the device of claim 1 to the conjunctiva of the eye.

12. The method of claim 11 wherein the device is inserted into the upper or lower fornix of the eye.

13. The method of claim 11, wherein the device is implanted episclerally in the eye and the active agent is released at a rate of 0.00025 to 0.0075 micrograms/hr.

14. The method of claim 13, wherein the active agent comprises latanoprost arginine salt.

15. The method of claim 11, wherein the device is placed supraconjunctivally in the eye and the active agent is released at a rate of 0.00025 to 0.0075 micrograms/hr.

16. The method of claim 15, wherein the active agent comprises latanoprost arginine salt.