OCULAR THERAPEUTIC AGENT DELIVERY DEVICES AND METHODS FOR MAKING AND USING SUCH DEVICES

• US 20070190111A1
• Filed: 04/24/2007
• Published: 08/16/2007
• Est. Priority Date: 03/15/2001
• Status: Abandoned Application

• Current Assignee: Govemment of The USA Represented By The Secretary Department of Health and Human
• Original Assignee: Govemment of The USA Represented By The Secretary Department of Health and Human
• Inventors: Yuan, Peng, Robinson, Michael, Sung, Cynthia, Kim, Hyuncheol, Csaky, Karl, Fronheiser, Matthew, Nussenblatt, Robert, Smith, Janine
• Application Number:
  US11/739,540
• Publication Number:
  US 20070190111A1
• 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: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5089 Processes
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: B29D 11/023 Implants for natural eyes
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2827/18 PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: Y10S 425/808 Lens mold

Abstract

Ocular implant devices (10, 20, 121) for the delivery of a therapeutic agent to an eye (101, 301) in a controlled and sustained manner. Dual mode and single mode drug delivery devices (10, 20, 121) are illustrated and described. Implants (10, 20) suitable for subconjunctival placement are described. Implants (121, 10, 20) suitable for intravitreal placement also are described. The invention also includes fabrication and implementation techniques associated with the unique ocular implant devices (10, 20, 121) that are presented herein.

Claims

1. A method of preventing or reducing graft rejection in a mammalian eye following corneal transplantation, the method comprising the step of:

implanting at a subconjunctival location, a sustained release implant comprising an immune system modifying agent dispersed within a nonbiodegradable polymer, such that the implant releases the agent continuously to the eye at a substantially constant release rate for at least three months to prevent or reduce graft rejection in the eye.

2. The method according to claim 1, wherein the agent is cyclosporine A.

3. The method according to claim 1, wherein the implant further comprises a discrete solid core containing the immune system modifying agent or a second therapeutic agent.

4. The method according to claim 1, wherein the polymer is silicone.

5. The method according to claim 2, wherein the polymer is silicone.

6. The method according to claim 3, wherein the polymer is silicone.

7. The method according to claim 1, wherein the polymer is poly(ethylene vinyl) acetate (EVA).

8. The method according to claim 2, wherein the polymer is poly(ethylene vinyl) acetate (EVA).

9. The method according to claim 3, wherein the polymer is poly(ethylene vinyl) acetate (EVA).

10. The method according to claim 1, wherein the polymer is biologically inert.

11. The method according to claim 1, wherein the implant releases the agent continuously to the eye at a substantially constant rate for at least six months.