Intravitreal drug delivery systems for the treatment of ocular conditions

Patent metadata

Field	Value
Publication number	US-10624904-B2
Application number	US-201615746797-A
Country	US
Kind code	B2
Filing date	Jul 22, 2016
Priority date	Jul 23, 2015
Publication date	Apr 21, 2020
Grant date	Apr 21, 2020

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 pharmaceutical composition for treating an ocular condition, 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; and
wherein the pharmaceutical composition is formulated for intravitreal administration to a subject's eye; and
wherein the pharmaceutical composition is formulated to release the at least one corticosteroid for at least about 4 months.

2. The pharmaceutical composition according to claim 1 , wherein the at least one corticosteroid is dexamethasone, fluocinolone acetonide, or a combination thereof.

3. The pharmaceutical composition according to claim 1 , wherein the at least one corticosteroid is fluocinolone acetonide.

4. The pharmaceutical composition according to claim 1 , wherein the at least one corticosteroid is dexamethasone.

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

6. The pharmaceutical composition according to claim 1 , wherein the biodegradable polymer matrix comprises: 85±5 wt % of a biodegradable poly(D,L-lactide-co-glycolide) copolymer having an inherent viscosity of 0.45 to 0.60 dL/g measured at 0.1% w/v in CHCl 3 at 25° C. with an Ubbelhode size 0c glass capillary viscometer.

7. The pharmaceutical composition according to claim 1 , wherein the biodegradable polymer matrix comprises: 85±5 wt % of a biodegradable poly(D,L-lactide-co-glycolide) copolymer having 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.

8. An intravitreal implant for treating an ocular condition, comprising the pharmaceutical composition of claim 1 .

9. A method of treating an ocular condition in a human in need thereof, comprising administering at least one intravitreal implant of claim 8 to the vitreous humor of an eye of the human.

10. The method according to claim 9 , wherein the ocular condition is macular edema, retinal vein occlusion, or uveitis.

Assignees

• Aerie Pharmaceuticals Inc

Inventors

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

Classifications

• A61K31/573

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

• A61K9/10

  Dispersions; Emulsions · CPC title

• A61K9/0048 Primary

  Eye, e.g. artificial tears · CPC title

• A61K31/58 Primary

  containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) · CPC title

• A61K47/36

  Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin · CPC title