DRUG ELUTING OCULAR CONFORMER

• US 20090162417A1
• Filed: 12/17/2008
• Published: 06/25/2009
• Est. Priority Date: 12/21/2007
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Eells, Scott E.
• Application Number:
  US12/337,369
• Publication Number:
  US 20090162417A1
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 9/00 Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand caps with means for protecting the eyes A42B1/018; visors for helmets A42B3/22; retractors A61B17/02; manipulators specially adapted for use in surgery A61B34/70; appliances to aid invalids to move about A61H3/00; exercisers for the eyes A61H5/00; eye baths A61H35/02; sunglasses or goggles having the same features as spectacles G02C
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

A coated, drug eluting ocular conformer includes an ocular conformer and at least one substantially purified anti-fibrosis agent. The ocular conformer is formed from a base material having inner and outer sides, including apical and basal portions configured to contact one or more conjunctival tissues in an eye of a patient. The anti-fibrosis agent is formulated into at least one ophthalmic medicament layer over at least one side of the ocular conformer or is impregnated within the base material of the ocular conformer. The device may be configured to release the anti-fibrosis agent from one or both sides of the ocular conformer. An elution control layer may be included to facilitate controlled release of the anti-fibrosis agent. In addition, an adhesion promoting layer may be included in the device to promote adhesion of polymeric layers to the base material or to ocular tissues during delivery. The coated, drug eluting ocular conformer may be used to reduce scarring in the eye, typically by applying the device to the eye following eye surgery, an eye injury caused by chemical, thermal or mechanical trauma, or an eye disease or condition associated with scarring.

Claims

1. A coated, drug eluting ocular conformer device comprising:

an ocular conformer formed from a base material and having inner and outer sides including apical and basal portions configured to contact one or more conjunctival tissues in an eye of a patient; and

at least one substantially purified anti-fibrosis agent, wherein the anti-fibrosis agent is formulated into at least one ophthalmic medicament layer over at least one surface of the ocular conformer or impregnated within the base material of the ocular conformer.

2. The device of claim 1, wherein the anti-fibrosis agent is impregnated within the base material of the ocular conformer.

3. The device of claim 1, wherein the medicament layer is configured to release the anti-fibrosis agent from the inner side of the ocular conformer to the upper bulbar conjunctiva and the lower bulbar conjunctiva.

4. The device of claim 3, wherein the at least one medicament layer is configured not to release the anti-fibrosis agent from the outer side of the ocular conformer to the cornea.

5. The device of claim 1, wherein the at least one medicament layer is configured to release the anti-fibrosis agent to the cornea, but not to the inner side of the ocular conformer to the upper bulbar conjunctiva and the lower bulbar conjunctiva.

6. The device of claim 1, wherein the at least one medicament layer is configured to release the anti-fibrosis agent from the outer side of the ocular conformer to the upper palpebral conjunctiva and the lower palpebral conjunctiva.

7. The device of claim 4, comprising medicament layers configured to release the anti-fibrosis agent from both sides of the ocular conformer to each of the upper bulbar conjunctiva, lower bulbar conjunctiva, upper palpebral conjunctiva, and lower palpebral conjunctiva.

8. The device of claim 1, wherein the at least one medicament layer is formed by spraying the anti-fibrosis agent onto at least one surface of the ocular conformer.

9. The device of claim 1, further comprising an elution control layer posited over the at least one medicament layer or over the base material impregnated with the anti-fibrosis agent.

10. The device of claim 9, wherein the elution control layer is comprised of a porous polymer.

11. The device of claim 10, wherein the porous polymer comprises a parylene or a parylene derivative.

12. The device of claim 9, wherein the elution control layer is comprised of a biodegradable elastomeric polymer.

13. The device of claim 12, wherein the biodegradable elastomer comprises a polylactic acid, a polyglycolic acid, or a copolymer therefrom.

14. The device of claim 1, further comprising an adhesion promoting layer.

15. The device of claim 14, wherein the adhesion promoting layer is between the medicament layer and a surface of the ocular conformer.

16. The device of claim 14, wherein the adhesion promoting layer comprises a multilayer coating on an outer surface on the inner side of the ocular conformer.

17. The device of claim 16, wherein the multilayer coating comprises a bioadhesive layer and a water-soluble non-adhesive backing layer, wherein the bioadhesive layer comprises at least one bioadhesive polymer and at least one water-soluble film-forming polymer.

18. The device of claim 17, wherein the bioadhesive polymer is selected form the group consisting of polyacrylic acid, sodium carboxymethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropylmethyl cellulose, polyvinylpyrrolidone (PVP), and combinations thereof.

19. A method for making a coated, drug eluting ocular conformer device according to claim 1 comprising:

providing an ocular conformer formed from a base material, the conformer having an inner side and an outer side, the inner side being configured to contact an eye; and

impregnating within the base material of the ocular conformer at least one substantially purified anti-fibrosis agent or positing on at least one side of the ocular conformer an ophthalmic medicament layer comprising a substantially purified anti-fibrosis agent.

20. A method for protecting against scarring in the eye comprising applying to an eye of a patient, the coated, drug eluting ocular conformer device according to claim 1.