Steroid-containing sustained release intraocular implants and related methods

• US 20070298073A1
• Filed: 06/23/2006
• Published: 12/27/2007
• Est. Priority Date: 06/23/2006
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Whitcup, Scott M., Robinson, Michael R.
• Application Number:
  US11/473,947
• Publication Number:
  US 20070298073A1
• 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 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers

Abstract

Biocompatible intraocular implant systems are formulated for discontinuous or intermittent release of therapeutic levels of a therapeutic agent (such as a steroid) to minimize development of side effects associated with continuous or long term use of such agent. The implant system may comprise one or more implant, and preferably, although not necessarily, also contains an auxiliary agent having an activity effective to lessen at least one side effect associated with said therapeutic agent compared to the use of an otherwise identical implant system lacking said auxiliary agent. The implants containing the therapeutic agent and auxiliary agent may be placed in an eye to treat one or more ocular conditions while reducing the ocular side effects otherwise accompanying the use of such therapeutic agent.

Claims

1. An intraocular implant system comprising:

an implant sized and adapted for intraocular placement and comprising a therapeutic component associated with a biodegradable polymer, the implant being structured to release the therapeutic component discontinuously or intermittently over time after intraocular implantation of said implant.

2. The system of claim 1 wherein the implant is structured to release the therapeutic component for a first period of time, to release substantially no therapeutic component for a second period of time after the first period of time, and to release the therapeutic component for a third period of time after the second period of time, the first, second and third periods of time being after intraocular implantation of said implant.

3. The system of claim 1 wherein the implant has a layered structure to facilitate the discontinuous or intermittent release of the therapeutic component after intraocular implantation of said implant.

4. The system of claim 1 wherein the implant comprises a plurality of particles which are differently structured to facilitate the discontinuous or intermittent release of the therapeutic component after intraocular implantation of said implant.

5. The system of claim 2 wherein each of the first, second and third periods of time is at least about 1 week.

6. The system of claim 2 wherein each of the first, second and third periods of time is at least about 2 weeks.

7. The system of claim 1 wherein the implant comprises a plurality of particles including particles structured to release the therapeutic component during different periods of time after intraocular implantation of said implant.

8. The system of claim 1 wherein the therapeutic component is selected from the group consisting of steroids, antiangiogenics, neuroprotectants, antibiotics antiviral agents and NSAIDS.

9. The system of claim 1 wherein the therapeutic component comprises a steroid.

10. The system of claim 1 wherein the biodegradable polymer comprises a PLGA copolymer.

30. The system of claim 1 wherein the therapeutic component is selected from the group consisting of cortisone, prednisolone, flurometholone, dexamethasone, medrysone, loteprednol, fluazacort, hydrocortisone, prednisolone, betamethasone, prednisone, methylprednisolone, riamcinolone hexacatonide, paramethasone acetate, triamcinolone acetonide, diflorasone, fluocinonide, derivatives thereof, and mixtures thereof.

11. An intraocular implant system comprising:

a first implant sized and adapted for intraocular placement and comprising a therapeutic component associated with a biodegradable polymer; and

a second implant sized and adapted for intraocular placement and comprising an auxiliary agent associated with a biodegradable polymer, at least one of the first and second implants is structured to release at least one of the therapeutic component and the auxiliary agent discontinuously or intermittently after intraocular placement.

12. The system of claim 11 wherein the first and second implants are included in a single intraocular implant sized and adapted for intraocular placement.

13. The system of claim 12 wherein the therapeutic component and the auxiliary agent are associated with the same biodegradable polymer.

14. The system of claim 12 wherein the therapeutic component and the auxiliary agent are present in different portions of the single intraocular implant.

15. The system of claim 11 wherein at least one of the first and second implants is structured to release at least one of the therapeutic component and the auxiliary agent so that substantially only one of the therapeutic component and the auxiliary agent is being released during one or more periods of time after intraocular placement.

16. The system of claim 11 wherein the first and second implants are structured to release the therapeutic component and the auxiliary agent so that substantially only the auxiliary agent is being released during one or more periods of time after intraocular placement.

17. The system of claim 11 wherein at least one of the first and second implants is structured to release the therapeutic component so that during one or more periods of time after implantation in an eye the intraocular concentration of the therapeutic component is reduced sufficiently to decrease the risk of an adverse side effect of the therapeutic component relative to maintaining a higher intraocular concentration of the therapeutic component during the one or more periods of time after intraocular placement.

18. The system of claim 11 wherein the first and second implants are included in different implant portions sized and adapted for intraocular placement at substantially the same time.

19. The system of claim 18 wherein each different implant portion is structured to release, after intraocular placement, at least one of the therapeutic component and the auxiliary agent according to one or more parameter selected from the group consisting of a) a different time, and b) a different rate, from at least one other implant portion.

20. The system of claim 18 wherein the different implant portions are structured to independently release the therapeutic component and the auxiliary agent at different times (and/or at different rates) after intraocular placement.

21. The system of claim 11 wherein at least one of the first and second implants has a layered structure to facilitate the discontinuous or intermittent release of at least one of the therapeutic component and the auxiliary agent after intraocular placement.

22. The system of claim 11 wherein at least one of the first and second implants comprise a plurality of particles (elements) which are differently structured to facilitate the discontinuous or intermittent release of at least one of the therapeutic component and the auxiliary agent after intraocular placement.

23. The system of claim 11 wherein at least one of the first and second implants comprise a plurality of particles including particles with release the therapeutic component and the auxiliary agent during different periods of time after intraocular placement.

24. The system of claim 11 wherein the therapeutic component is selected from the group consisting of steroids, antiangiogenics, neuroprotectants, antibiotics, antiviral agents, antifungal agents, anti-parasitic agents and NSAIDS.

25. The system of claim 11 wherein the auxiliary agent comprises a different therapeutic component.

26. The system of claim 11 wherein the auxiliary agent is selected to be effective to reduce the risk of an adverse side effect of the therapeutic component in an eye.

27. The system of claim 11 wherein the auxiliary agent is selected from the group consisting of anti-glaucoma drugs (including neuroprotectants), antibiotics, vitamins, nucleotides, chaperone proteins and carrier proteins.

28. The system of claim 11 wherein the therapeutic component comprises a steroid and the auxiliary agent comprises an anti-glaucoma drug.

29. The system of claim 17 wherein the therapeutic component comprises a steroid and the auxiliary agent comprises an anti-glaucoma drug, and the adverse side effect is glaucoma.