Composition and method for treating glaucoma

• US 6,369,116 B1
• Filed: 12/23/1998
• Issued: 04/09/2002
• Est. Priority Date: 06/02/1995
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Oculex Pharmaceuticals, Inc. (Abbvie Incorporated)
• Inventors: Wong, Vernon, Peng, Lin
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US09/221,002
• Time in Patent Office: 1,203 Days
• Field of Search: 424/484, 424/486, 424/488, 514/944, 514/913
• US Class Current: 514/171
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Implants and methods are provided for modulating wound healing and controlling infection to improve the success of glaucoma filtration surgery. Formulations of one or more therapeutically active agents and a biodegradable polymer provide a substantially constant rate of release for an extended period of time.

Claims

1. A method for improving the post-operative success of glaucoma filtration surgery, said method comprising the steps of:

introducing proximal to the surgical site an implant comprising dexamethasone at a concentration from about 40 to 80 weight percent of the implant and poly-lactate glycolic acid copolymer at a concentration of at least about 20 weight percent of the implant;

wherein said therapeutically active agent is released within a therapeutic dosage which does not vary by more than about 100% for a period of at least about 3 weeks.

2. A method according to claim 1, wherein said implant further comprises a release modular.

3. A method according to claim 2, wherein said release modulator is a hydrophilic entity.

4. A method according to claim 2, wherein said release modulator is hydroxypropylmethylcellulose.

5. A method according to claim 2, wherein said release modulator is a therapeutically active agent.

6. A method according to claim 5, wherein said release modulator is a water soluble antibiotic.

7. A method according to claim 6, wherein said release modulator is ciprofloxacin.

8. A method according to claim 5, wherein said release modulator is an anti-proliferative agent.

9. An implant according to claim 8, wherein said release modulator is 5-fluorouracil.

10. A method according to claim 1, wherein said poly-lactate glycolic acid copolymer has a relative average molecular weight between about 10 and about 60 kD.

11. A method according to claim 1, wherein said implant is introduced intrasclerally beneath a partical-thickness scleral flap created during glaucoma filtration surgery.

12. A method according to claim 11, comprising the additional step of positioning said implant upon introduction beneath said partial-thickness scleral flap such that said flap partially covers said implant when closed.

13. A method according to claim 1, wherein said implant is introduced episclerally.

14. A method for improving the post-operative success of glaucoma filtration surgery, said method comprising the steps of:

introducing proximal to the surgical site an implant comprising dexamethasone at a concentration from about 40 to 80 weight percent of the implant and a poly-lactate glycolic acid copolymer having a relative average molecular weight between about 10 and about 60 kD at a concentration of at least about 20 weight percent of the implant;

wherein said therapeutically active agent is released within a therapeutic dosage which does not vary by more than about 100% for a period of at least about 3 weeks.

15. A method according to claim 14, wherein said implant further comprises a release modulator.

16. A method according to claim 15, wherein said release modulator is a therapeutically active agent.

17. A method according to claim 16, wherein said release modulator is an anti-proliferative drug.

18. A method for improving the post-operative success of glaucoma filtration surgery, said method comprising the steps of:

introducing proximal to the surgical site an implant comprising a therapeutically active agent at a concentration from about 10 to 80 weight percent of the implant, hydroxypropylmethylcellulose at a concentration from about 10 to 50 weight percent of the implant, and at least one pharmacologically acceptable biodegradable polymer having a relative average molecular weight between about 10 and 60 kD at a concentration of at least about 20 weight percent of the implant;

wherein said therapeutically active agent is released within a therapeutic dosage which does not vary by more than about 100% for a period of at least about 3 weeks.

19. A method according to claim 18, wherein said pharmacologically acceptable biodegradabe polymer comprises a poly-lactate glycolic acid copolymer.