EXTENDED THERAPEUTIC EFFECT OCULAR IMPLANT TREATMENTS

• US 20080233172A1
• Filed: 03/25/2008
• Published: 09/25/2008
• Est. Priority Date: 04/30/2004
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Whitcup, Scott M., Weber, David A.
• Application Number:
  US12/055,235
• Publication Number:
  US 20080233172A1
• 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 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• 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 9/0024 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 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 27/00 Drugs for disorders of the senses
• 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: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators

Abstract

Methods for treating ocular conditions by inserting an implant comprising an active agent into an ocular site of a patient thereby obtaining an amelioration of a symptom of the ocular condition (i.e. a therapeutic effect) for an extended period of time during which a therapeutic amount or a detectable amount of the active agent is not present at the ocular site.

Claims

6. The method of 1, wherein the implant has a weight between about 1 μ

g and about 100 mg.

18. A method for treating a chronic ocular condition, the method comprising the steps of:

(a) inserting an implant into an ocular site of a patient with an ocular condition, the implant comprising (i) an active agent, and (ii) a carrier associated with the active agent;

(b) releasing substantially all of the active agent from the implant;

(c) obtaining an improvement in the ocular condition at a time when a therapeutic amount of the active agent is not present at the ocular site, and;

(d) maintaining the improvement in the ocular condition for an extended period of time during which a therapeutic amount of the active agent is not present at the ocular site.

19. A method for treating an inflammatory posterior ocular condition, the method comprising the steps of:

(a) inserting a biodegradable implant into a posterior ocular site of a patient with an inflammatory posterior ocular condition, the biodegradable implant comprising (i) an anti-inflammatory active agent mixed with (ii) a biodegradable polymer;

(b) releasing substantially all of the anti-inflammatory active agent from the biodegradable implant;

(c) obtaining an improvement in the inflammatory posterior ocular condition at a time when a therapeutic amount of the anti-inflammatory active agent is not present at the posterior ocular site, and;

(d) maintaining the improvement in the inflammatory ocular condition for an extended period of time during which a therapeutic amount of the anti-inflammatory active agent is not present at the posterior ocular site.

20. The method of claim 19, wherein the inserting step comprises the step of placing the biodegradable implant into the vitreous through the pars plana and placing the implant adjacent thereto in the vitreous cavity.

21. A method for treating persistent macular edema, the method comprising the steps of:

(a) inserting a biodegradable implant deep into the vitreous of a patient with persistent macular edema, the biodegradable implant comprising (i) dexamethasone mixed with (ii) a bioerodible PLGA co-polymer;

(b) releasing all of the dexamethasone from the biodegradable implant;

(c) obtaining an improvement in the persistent macular edema at a time when a therapeutic amount of the dexamethasone is not present in the vitreous, and;

(d) maintaining the improvement in the persistent macular edema for an extended period of time during which a therapeutic amount of the dexamethasone is not present in the vitreous.

1. A method for treating an ocular condition, the method comprising the steps of:

(a) inserting an implant into an ocular site of a patient with an ocular condition, the implant comprising (i) an active agent, and (ii) a carrier associated with the active agent;

(b) releasing substantially all of the active agent from the implant, and;

(c) obtaining an improvement in the ocular condition at a time when a therapeutic amount of the active agent is not present at the ocular site.

2. The method of claim 1, further comprising the step of maintaining the improvement in the ocular condition for an extended period of time during which a therapeutic amount of the active agent is not present at the ocular site.

3. The method of claim 2, wherein the releasing step occurs over a first period of time X, and the subsequent extended period of time during which an improvement in the ocular condition is maintained, although a therapeutic amount of the active agent is not present at the ocular site, is a second period of time between 0.5×

and 100×

.

4. The method of claim 1, wherein the active agent is an anti-inflammatory agent.

5. The method of claim 1, wherein the carrier is a bioerodible polymer.

7. The method of claim 1, wherein the implant has no dimension less than about 0.1 mm and no dimension greater than about 20 mm.

8. The method of claim 1 wherein the improvement of the ocular condition is determined by observing an improved visual acuity.

9. The method of claim 1 wherein the improvement of the ocular condition is determined by observing an improved visual contrast sensitivity.

10. The method of claim 1 wherein the improvement of the ocular condition is determined by observing a decreased retinal or choroidal blood vessel leakage.

11. The method of claim 1 wherein the improvement of the ocular condition is determined by observing a decreased retinal or macular thickness.

12. The method of claim 1, wherein the improvement in the ocular condition occurs at a time when a detectable amount of the active agent is not present at the ocular site.

13. The method of claim 1, wherein the ocular site is the vitreous.

14. The method of claim 1, wherein the active agent is dexamethasone.

15. The method of claim 3, wherein the first period of time is between about 30 days and about 40 days.

16. The method of claim 3, wherein the first period of time is about 35 days.

17. The method of claim 15, wherein the second period of time is between about 30 days and about 180 days.

22. The method of claim 21, wherein the inserting step comprises the step of placing the biodegradable implant into the vitreous about 2 mm to about 6 mm anterior of the macular

23. The method of claim 21, wherein the releasing step comprises the step of releasing about 700 μ

g of dexamethasone from the biodegradable implant.

24. The method of claim 23, wherein the releasing step comprises the step of releasing about 700 μ

g of dexamethasone from the biodegradable implant within about 30 days to 40 days after the inserting step.

25. The method of claim 24, wherein the improvement in the visual acuity of the patient is obtained within about 30 days to about 180 days after the inserting step.

26. The method of claim 25, wherein the maintaining step, by which the improvement in the visual acuity of the patient with persistent macular edema is maintained for an extended period of time during which a therapeutic amount of the dexamethasone is not present in the vitreous, is a period of time of about 30 days to about 150 days after the obtaining step.

24-1. The method of claim 21, wherein the obtaining step comprises obtaining an improvement in the visual acuity of the patient.

27. A method for improving the visual acuity of a patient with persistent macular edema, the method comprising the steps of:

(a) inserting a biodegradable implant into the vitreous of a patient with persistent macular edema by placing the biodegradable implant about 2 mm to about 6 mm anterior of the macular, the biodegradable implant comprising (i) about 700 μ

g dexamethasone mixed with (ii) a bioerodible PLGA co-polymer;

(b) releasing the 700 μ

g of dexamethasone from the biodegradable implant within about 30 days to about 40 days after the inserting step;

(c) obtaining an improvement in the visual acuity of the patient with the persistent macular edema at a time within about 30 days and 180 days after the inserting step during which time a therapeutic amount of the dexamethasone is not present in the vitreous, and;

(d) maintaining the improvement in the visual acuity of the patient with the persistent macular edema for about 30 days to about 150 days after the obtaining step during a time a therapeutic amount of the dexamethasone is not present in the vitreous.

28. A method for treating an ocular condition, the method comprising the steps of:

(a) inserting an implant into the vitreous cavity of a patient with an ocular condition, the implant comprising (i) a steroid, and (ii) a carrier associated with the steroid;

(b) releasing substantially all of the steroid from the implant, and;

(c) obtaining an improvement in the ocular condition with no increase in intraocular pressure above about 25 mm Hg.

29. A method for treating an ocular condition, the method comprising the steps of:

(a) inserting an implant into the vitreous cavity of a patient with an ocular condition, the implant comprising (i) a steroid, and (ii) a carrier associated with the steroid;

(b) releasing substantially all of the steroid from the implant, and;

(c) obtaining an improvement in the ocular condition with no occurrence of an ocular cataract in the patient.