INTRAOCULAR SUSTAINED RELEASE DRUG DELIVERY SYSTEMS AND METHODS FOR TREATING OCULAR CONDITIONS

• US 20100247606A1
• Filed: 03/25/2009
• Published: 09/30/2010
• Est. Priority Date: 03/25/2009
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Xu, Kun, Liu, Hui, Ghebremskel, Alazar N., Do, Marianne M., Orilla, Werhner C., Hughes, Patrick M., Spada, Lon T., Burke, James A., Whitcup, Scott, ROBINSON, Michael R.
• Application Number:
  US12/411,250
• Publication Number:
  US 20100247606A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics

Abstract

Biocompatible, bioerodible sustained release implants and microspheres for intracameral or anterior vitreal placement include an anti-hypertensive agent and a biodegradable polymer effective to treat an ocular hypertensive condition (such as glaucoma) by relapsing therapeutic amount of the anti-hypertensive agent over a period of time between 10 days and 1 year.

Claims

1. A method for treating elevated intraocular pressure, the method comprising the step of intracameral or anterior vitreal administration, to a patient with elevated intraocular pressure (IOP), of a sustained release implant comprising an anti-hypertensive agent and a biodegradable polymer, wherein the implant comprises from about 10 to about 50 weight percent the anti-hypertensive agent and from about 50 to about 90 weight percent the biodegradable polymer, and wherein the implant releases therapeutically effective amounts of the anti-hypertensive for a period of time between about 10 days and about 120 days.

2. The method of claim 1, wherein the implant can reduce IOP from about 20% to about 70% of baseline IOP.

18. The method of claim 1, wherein the antihypertensive agent is selected from the group consisting of Compounds A to O, and their salts, esters and prodrugs:

3. A method for treating elevated intraocular pressure, the method comprising the step of intracameral administration against the trabecular meshwork, to a patient with elevated intraocular pressure, of a sustained release rod shaped implant comprising latanoprost or bimatoprost and a biodegradable polymer, wherein the implant comprises from about 10 to about 50 weight percent the latanoprost or bimatoprost and from about 50 to about 90 weight percent the biodegradable polymer, wherein the implant releases therapeutically effective amounts of the latanoprost or bimatoprost for a period of time between about 10 days and about 120 days.

4. A method for treating elevated intraocular pressure, the method comprising the step of intracameral or anterior vitreal administration to a patient with elevated intraocular pressure a plurality of sustained release biodegradable microspheres having an average diameter between 30 and 60 microns, the microspheres comprising from about 10 to about 30 weight percent an anti-hypertensive agent and from about 70 to about 90 weight percent a biodegradable polymer, wherein the microspheres release therapeutically effective amounts of the anti-hypertensive agent for a period of time between about 10 days and about 120 days.

5. The method of claim 4, wherein the biodegradable polymer comprises a polylactic polyglycolic copolymer (PLGA) and/or a poly lactic acid polymer (PLA).

6. The method of claim 4, wherein the antihypertensive agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.

7. The method of claim 4, wherein the antihypertensive agent is selected from the group consisting of Compounds A to O, and their salts, esters and prodrugs:

8. The method of claim 4, wherein the drug delivery system comprises a high viscosity hyaluronic acid.

9. A method for treating elevated intraocular pressure, the method comprising the step of intracameral administration to a patient with elevated intraocular pressure a plurality of sustained release biodegradable microspheres having an average diameter between 30 and 60 microns, the microspheres comprising from about 10 to about 30 weight percent latanoprost and from about 70 to about 90 weight percent a biodegradable polymer, wherein the microspheres release therapeutically effective amounts of the latanoprost for a period of time between about 10 day and about 120 days.

10. A method for treating elevated intraocular pressure, the method comprising the step of intracameral administration against the trabecular meshwork, to a patient with elevated intraocular pressure, a sustained release rod shaped implant comprising latanoprost and a biodegradable polymer, wherein the implant comprises from about 10 to about 50 weight percent an anti-hypertensive agent and from about 50 to about 90 weight percent a biodegradable polymer, wherein the implant releases therapeutically effective amounts of the latanoprost for a period of time between about 10 day and about 120 days.

11. A pharmaceutical composition for intraocular use to treat an ocular condition, the composition comprising a plurality of sustained release biodegradable microspheres having an average diameter between 30 and 60 microns, the microspheres comprising from about 10 to about 30 weight percent an anti-hypertensive agent and from about 70 to about 90 weight percent a biodegradable polymer, wherein the microspheres release therapeutically effective amounts of the anti-hypertensive agent for a period of time between about 10 day and about 120 days.

12. The composition of claim 11 wherein the microspheres comprise from about 1% to about 99% by weight of the polymer.

13. The composition of claim 11, wherein the polymer is a PLGA.

14. The composition of claim method of claim 11, wherein the antihypertensive agent is selected from the group consisting of latanoprost, bimatoprost and travoprost and their salts, esters and prodrugs.

15. The composition of claim 11, wherein the antihypertensive agent is selected from the group consisting of Compounds A to O, and their salts, esters and prodrugs:

16. The composition of claim 11 further comprising a high viscosity hyaluronic acid.

17. The composition of claim 11 wherein the ocular condition is glaucoma.