DRUG DELIVERY DEVICES FOR DELIVERY OF OCULAR THERAPEUTIC AGENTS

• US 20130142858A1
• Filed: 05/17/2011
• Published: 06/06/2013
• Est. Priority Date: 05/17/2010
• Status: Abandoned Application

• Current Assignee: Novaer Holdings, Inc.
• Original Assignee: Aerie Pharmaceuticals, Inc (Alcon Incorporated)
• Inventors: Kopczynski, Casey, Sutay, Chris, Lin, Cheng-Wen
• Application Number:
  US13/642,042
• Publication Number:
  US 20130142858A1
• Time in Patent Office: Days
• 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, the device comprising:

a first portion including a recess configured to support a composition comprising an active agent, the first portion comprising an impermeable polymer; and

a second portion fused to the first portion, the second portion comprising a rate-limiting water-permeable polymer that allows for transportation of the active agent to an exterior of the device, wherein the rate-limiting water-permeable polymer includes a thickness in a range of about 20 μ

m to about 500 μ

m.

2. The device set forth in claim 1 further comprising

a flange fused to the second portion.

3. The device set forth in claim 1 wherein

the second portion includes a base and a flange integral with the base.

27. The device set forth in claim 1, wherein the device is substantially cylindrical-shaped.

4. A device for insertion in the eye, the device comprising:

a first portion comprising a rate-limiting water-permeable polymer;

a second portion fused to the first portion, the second portion including a recess configured to support a composition comprising an active agent, the second portion comprising a rate-limiting water-permeable polymer; and

a third portion fused to the second portion, the third portion comprising a rate-limiting water-permeable polymer,

wherein the rate-limiting water-permeable polymer includes a thickness in a range of about 20 μ

m to about 500 μ

m and allows for transportation of the active agent to an exterior of the device.

28. The device set forth in claim 4, wherein the device is substantially cylindrical-shaped.

5. A device for insertion in the eye, the device comprising:

a non-bioabsorbable polymer structure comprising a rate-limiting water-permeable polymer; and

a composition supported within an enclosure of the non-bioabsorbable polymer structure, the composition including an active agent;

wherein the non-bioabsorbable polymer structure includes a thickness in a range of about 200 μ

m to about 800 μ

m, and wherein the thickness is configured to control an elution rate of the active agent through the rate-limiting water-permeable polymer, wherein the rate-limiting water-permeable polymer is a copolymer having both hydrophobic and hydrophilic monomers.

6. The device set forth in claim 5, wherein the rate-limiting water-permeable polymer is selected from the group consisting of:

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

8. The device set forth in claim 5, wherein the active agent is selected from the group consisting of:

3-hydroxy-2,2-bis(hydroxymethyl)propyl 7-((1R,2R,3R,5S)-2-((R)-3-(benzo[b]thiophen-2-yl)-3-hydroxypropyl)-3,5-dihydroxycyclopentyl)heptanoate (AR-102), 7-((1R,2R,3R,5S)-2-((R)-3-(benzo[b]thiophen-2-yl)-3-hydroxypropyl)-3,5-dihydroxycyclopentyl)heptanoic acid (AR-102 free acid), dorzolamide, ethacrynic acid, latanoprost, latanoprost free acid, travoprost, travoprost free acid, bimatoprost, bimatoprost free acid, tafluprost, tafluprost free acid, dexamethasone, brimonidine, timolol, or salts thereof.

9. A method of treating an ocular condition comprising inserting the device of any one of claims 5, 6, and 8 to the conjunctiva of the eye.

10. The method of claim 9 wherein the device is inserted into the upper or lower formix of the eye.

29. The device set forth in claim 5, wherein the device is substantially cylindrical-shaped.

7. (canceled)

11. A method of treating an ocular condition comprising implanting episclerally or supraconjunctivally a drug delivery device comprising an active agent, wherein the active agent is released at a rate of about 0.0001 to about 200 micrograms/hr.

12. The method of claim 11, wherein the active agent is released at a rate of about 0.0001 to about 30 micrograms/hr.

13. The method of claim 11, wherein the active agent is released at a rate of about 0.001 micrograms/hr to about 30 micrograms/hr.

14. The method of claim 11, wherein the active agent is released at a rate of about 0.001 micrograms/hr to about 10 micrograms/hr.

15. The method of claim 11, wherein the active agent comprises a prostaglandin active agent, the active agent being implanted episclerally and being released at a rate of about 0.00025 to about 0.0075 micrograms/hr.

16. The method of claim 15, wherein the active agent comprises latanoprost, travoprost, bimatoprost, each of their free acids or salts.

17. The method of claim 11, wherein the active agent comprises a prostaglandin active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.0005 to about 0.015 micrograms/hr.

18. The method of claim 17, wherein the active agent comprises latanoprost, travoprost, bimatoprost, each of their free acids or salts.

19. The method of claim 11, wherein the active agent comprises a rho-kinase active agent, the active agent being implanted episclerally, and being released at a rate of about 0.02 to about 0.6 micrograms/hr.

20. The method of claim 19, wherein the active agent comprises a Y-39983 salt.

21. The method of claim 11, wherein the active agent comprises a rho-kinase active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.04 to about 1.2 micrograms/hr.

22. The method of claim 21, wherein the active agent comprises a Y-39983 salt.

23. The method of claim 11, wherein the active agent is a non-prostaglandin and non-rho-kinase active agent, the active agent being implanted episclerally and being released at a rate of about 0.25 to about 7.5 micrograms/hr.

24. The method of claim 23, wherein the active agent comprises timolol or a salt thereof.

25. The method of claim 11, wherein the active agent is a non-prostaglandin and non-rho-kinase active agent, the active agent being implanted supraconjunctivally and being released at a rate of about 0.5 to about 15 micrograms/hr.

26. The method of claim 25, wherein the active agent comprises timolol or a salt thereof.