EXTENDED RELEASE BIODEGRADABLE OCULAR IMPLANTS

• US 20080241223A1
• Filed: 05/01/2008
• Published: 10/02/2008
• Est. Priority Date: 04/30/2004
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Lin, Qing, Shiah, Jane Guo, NIVAGGIOLI, Thierry
• Application Number:
  US12/113,434
• Publication Number:
  US 20080241223A1
• Time in Patent Office: Days
• US Class Current: 424/428
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• 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 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

Biodegradable implants sized and suitable for implantation in an ocular region or site and methods for treating ocular conditions. The implants provide an extended release of an active agent at a therapeutically effective amount for a period of time between 50 days and one year, or longer.

Claims

1. (canceled)

10. (canceled)

11. (canceled)

18. (canceled)

21-26. -26. (canceled)

28-40. -40. (canceled)

41. A method for treating an ocular condition, the method comprising implanting into an ocular region or site a drug delivery system comprising:

(a) at least one bioerodible implant suitable for insertion into an ocular region or site, the bioerodible implant comprising;

(i) an active agent, and;

(ii) a bioerodible polymer,

wherein the bioerodible implant can release a therapeutic level of the active agent at a substantially continuous rate upon insertion into an ocular region or site for a period time between about 50 days and about 1 year.

2. The method of claim 41, wherein the active agent is an anti-inflammatory agent.

3. The method of claim 41, wherein the bioerodible polymer is a PLGA co-polymer.

4. The method of claim 41, wherein the bioerodible implant has a weight between about 1 μ

g and about 100 mg.

5. The method of claim 41, wherein the bioerodible implant has no dimension less than about 0.1 mm and no dimension greater than about 20 mm.

6. The method of claim 41, wherein the drug delivery system comprises a plurality of bioerodible implants.

7. The method of claim 41, wherein the active agent is substantially homogenously dispersed within the bioerodible polymer.

8. The method of claim 41, wherein the active agent is associated with the bioerodible polymer in the form of particles of active agent and bioerodible polymer.

9. The method of claim 41, wherein the drug delivery system comprises:

(a) a portion of the active agent substantially homogenously dispersed within a portion of the bioerodible polymer, and;

(b) a portion of the same or of a different active agent associated with a portion of same or of a different bioerodible polymer in the form of particles of active agent and the bioerodible polymer.

12. The claim 41, wherein the drug delivery system comprises:

(a) a first implant with a first release characteristic, and;

(b) a second implant with a second release characteristic,

wherein the first and second release characteristics differ.

13. The method of claim 12, wherein the release profile of the corresponds to the sum of the first and second release profiles.

14. The method of claim 41, wherein the drug delivery system comprises:

(a) a first implant with a first release characteristic,

(b) a second implant with a second release characteristic, and;

(c) a third implant with a third release characteristic.

15. The method of claim 14, wherein the release profile of the corresponds to the sum of the first, second and third release profiles.

16. The method of claim 41, wherein the drug delivery system comprises at least two different implants which have different bioerodible polymers.

17. The method of claim 14 comprising first, second and third bioerodible implants, wherein

the first implant comprises a first polymer with a first average molecular weight;

the second implant comprises a second polymer with a second average molecular weight, and

the third implant comprises a third polymer with a third average molecular weight.

19. The method of claim 41, wherein the active agent is an anti-angiogenesis compound.

20. The method of claim 41, wherein said drug delivery system comprises;

(a) a plurality of bioerodible implants implantable in a posterior ocular region, each implant comprising

(i) an anti-inflammatory drug, and;

(ii) a bioerodible polymer,

wherein the plurality of bioerodible implants can substantially continuously release the anti-inflammatory drug at a level of at least about a 10 ng/ml dexamethasone equivalent for a period of between 5 days and 1 year.

27. The method of claim 20 wherein the implant can substantially continuously release the active agent at a level corresponding to at least 50 ng/ml of dexamethasone or dexamethasone equivalent for a period of at least about 50 days.