Intravitreal drug delivery systems for the treatment of ocular conditions

Patent metadata

Field	Value
Publication number	US-11116776-B2
Application number	US-201916712624-A
Country	US
Kind code	B2
Filing date	Dec 12, 2019
Priority date	Jul 23, 2015
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

The disclosure teaches precisely engineered biodegradable drug delivery systems and methods of making and utilizing such systems. In aspects, the biodegradable drug delivery systems taught herein comprise intravitreal ocular implants suitable for delivery of corticosteroids to the posterior segment of a human eye. The intravitreal ocular implants described herein have a desired extended drug release profile suitable for treating inflammation of the human eye.

First claim

What is claimed is:

1. A method of treating an ocular condition in a subject in need thereof, comprising administering to an eye of the subject an effective amount of a composition comprising:
A) a biodegradable polymer matrix, comprising a first biodegradable poly(D,L-lactide-co-glycolide) (PLGA) copolymer, a second biodegradable PLGA copolymer, and a third biodegradable PLGA copolymer; and
B) at least one corticosteroid homogenously dispersed within the biodegradable polymer matrix.

2. The method of claim 1 , wherein the composition is administered to the vitreous humor of an eye of the subject.

3. The method of claim 1 , wherein the pharmaceutical composition is formulated to release the at least one corticosteroid for at least about 4 months.

4. The method of claim 1 , wherein the at least one corticosteroid is dexamethasone, fluocinolone acetonide, or a combination thereof.

5. The method of claim 1 , wherein the at least one corticosteroid is fluocinolone acetonide.

6. The method of claim 1 , wherein the at least one corticosteroid is dexamethasone.

7. The method of claim 1 , wherein the at least one corticosteroid comprises about 35 weight percent to about 45 weight percent of the pharmaceutical composition.

8. The method of claim 1 , wherein the the first biodegradable PLGA copolymer has an inherent viscosity of 0.45 to 0.60 dig measured at 0.1% w/v in CHCl 3 at 25° C. with an Ubbelhode size 0c glass capillary viscometer, and is 85±5 wt % of the biodegradable polymer matrix.

9. The method of claim 1 , wherein the the first biodegradable PLGA copolymer has an inherent viscosity of 0.32-0.44 dL/g measured at 0.1% w/v in CHCl 3 at 25° C. with an Ubbelhode size 0c glass capillary viscometer, and is 85±5 wt % of the biodegradable polymer matrix.

10. The method of claim 1 , wherein the subject is a dog, cat, horse, livestock, or human.

11. The method of claim 1 , wherein the subject is a human.

12. The method of claim 1 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

13. The method of claim 2 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

14. The method of claim 1 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

15. The method of claim 4 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

16. The method of claim 5 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

17. The method of claim 6 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

18. The method of claim 7 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

19. The method of claim 8 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

20. The method of claim 9 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

21. The method of claim 10 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

22. The method of claim 11 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

23. The method of claim 2 , wherein the at least one corticosteroid is dexamethasone.

24. The method of claim 3 , wherein the at least one corticosteroid is dexamethasone.

25. The method of claim 7 , wherein the at least one corticosteroid is dexamethasone.

26. The method of claim 11 , wherein the at least one corticosteroid is dexamethasone.

Assignees

• Aerie Pharmaceuticals Inc

Inventors

• Williams Stuart
• Das Sanjib Kumar
• Navratil Tomas
• Sandahl Melissa
• Tully Janet
• Verhoeven Rozemarijn

Classifications

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61K47/34

  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 title

• A61K31/573

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title