Steroid-containing sustained release intraocular implants and related methods

• US 20050244474A1
• Filed: 04/29/2005
• Published: 11/03/2005
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Sugimoto, Hiroshi, Spada, Lon T., Nivaggioli, Thierry, Chang, James N., Olejnik, Orest, Blanda, Wendy M., Huang, Glenn T.
• Granted Patent: US 8,257,730 B2
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/14 Decongestants or antiallergics

Abstract

Biocompatible intraocular implants include a steroid and a polymer associated with each other to facilitate release of the steroid into an eye for a period of time greater than about two months. The steroid may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the steroid may be associated with a polymeric coating having one or more openings effective to permit the steroid to be released into an external environment. The implants may be placed in an eye to treat one or more ocular conditions. The steroid is released from the implant for more than about two months, and may be release for more than several years.

Claims

1. A biodegradable intraocular implant, comprising:

a steroid associated with a biodegradable polymer in the form of an intraocular implant having a steroid release-rate profile, the release-rate profile having a first portion in which the steroid is released substantially independently of a hydrolytic property of the biodegradable polymer, and a second portion in which the steroid release is more dependent on the hydrolytic property of the biodegradable polymer than during the first portion.

2. The implant of claim 1, wherein the steroid is selected from the group consisting of dexamethasone, fluocinolone, fluocinolone acetonide, triamcinolone, triamcinolone acetonide, salts thereof, and mixtures thereof

3. The implant of claim 1, wherein the biodegradable polymer is a poly(lactide-co-glycolide) polymer.

4. The implant of claim 1, wherein the first portion of the release-rate profile corresponds to a time period from about 1 day to about 30 days after placement of the implant in a liquid environment.

5. The implant of claim 4, wherein the second portion corresponds to a time period from about 30 days to about 90 days after placement of the implant in the liquid environment.

6. The implant of claim 1, wherein the first portion of the release-rate profile corresponds to a time period when less than about 10% of the steroid is released from the implant.

7. The implant of claim 6, wherein the second portion corresponds to a time period when less than about 40% of the steroid is released from the implant.

8. The implant of claim 6, wherein the second portion corresponds to a time period when less than about 100% of the steroid is released from the implant.

9. A biodegradable intraocular implant, comprising:

a steroid associated with a biodegradable polymeric component in the form of an intraocular implant structured for intravitreal placement in an eye of an individual, the steroid being present in an amount effective in treating an ocular condition of the eye with a reduced toxicity relative to intravitreal injection of a liquid composition containing the same steroid.

10. The implant of claim 9, wherein the steroid is selected from the group consisting of dexamethasone, fluocinolone, fluocinolone acetonide, triamcinolone, triamcinolone acetonide, salts thereof, and mixtures thereof

11. The implant of claim 9, wherein the biodegradable polymeric component comprises a poly(lactide-co-glycolide)polymer.

12. The implant of claim 9, wherein the steroid is released from the implant for at least about 2 months after the implant is placed in the vitreous of the eye.

13. A biodegradable intraocular implant, comprising:

a steroid associated with a polymeric component substantially free of silicone, in the form of an intraocular implant structured for placement in the vitreous of an eye of a patient and effective in releasing a therapeutically effective amount of the steroid from the implant for at least about two months after the implant is placed in the vitreous of an eye.

14. The implant of claim 13, wherein the steroid is selected from the group consisting of dexamethasone, fluocinolone, fluocinolone acetonide, triamcinolone, triamcinolone acetonide, salts thereof, and mixtures thereof.

15. The implant of claim 13, wherein the polymeric component coprises a biodegradable polymer.

16. The implant of claim 13 which is in the form of a tablet.

17. The implant of claim 13, further comprising an adesion member to affix the implant in the vitreous of the eye.

18. The implant of claim 13, wherein the implant releases the steroid in a therapeutically effective amount without the patient developing a cataract.