Methods and devices for the treatment of ocular conditions

• US 8,454,582 B2
• Filed: 12/29/2010
• Issued: 06/04/2013
• Est. Priority Date: 07/02/2004
• Status: Expired due to Fees

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: deJuan, Eugene, Varner, Signe E., Lawin, Laurie R.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): SAMALA, JAGADISHWAR RAO
• Application Number:
  US12/981,038
• Publication Number:
  US 20110159073A1
• Time in Patent Office: 888 Days
• Field of Search: 424/427, 424/428, 424/487, 604/290, 604/521, 604/890.1, 604/891.1, 604/892.1
• US Class Current: 604/891.1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Featured is a method for instilling one or more bioactive agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising concurrently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a sustained release delivery device comprising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more bioactive agents subretinally; and (C) instilling (e.g., injecting or delivering by ocular iontophoresis) one or more bioactive agents into the vitreous humor of the eye.

Claims

1. A method for instilling one or more bioactive agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising concurrently using at least two of the bioactive agent delivery methods (A)-(C):

(A) implanting a sustained release delivery device comprising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more bioactive agents into a vitreous humor;

(B) instilling one or more bioactive agents subretinally by direct injection or by implantation of a delivery device comprising one or more bioactive agents; and

(C) instilling one or more bioactive agents into the vitreous humor by direct injection or by iontophoresis.

2. The method of claim 1, wherein method (A) is used concurrently with method (B).

3. The method of claim 1, wherein method (A) is used concurrently with method (C).

4. The method of claim 1, wherein method (B) is used concurrently with method (C).

5. The method of claim 1, wherein method (A) is used concurrently with method (B) and with method (C).

6. The method of claim 1, wherein method (B) comprises:

(a) forming a localized retinal detachment to define a subretinal space; and

(b) instilling one or more bioactive agents in the subretinal space formed by localized retinal detachment.

7. The method of claim 1 wherein the one or more bioactive agents are provided in a sustained release delivery device that is configured for implantation in the subretinal space.

8. The method of claim 7, wherein the sustained release delivery device of (B) is tapered at a proximal end, a distal end, or both the proximal and distal ends.

9. The method of claim 7, wherein the sustained release delivery device of (B) is a solid in the form of a capsule, pellet, rod, sheet, or film.

10. The method of claim 7, wherein the sustained release delivery device of (B) comprises a core having an outer surface;

and a coating layer of a polymer matrix and at least one bioactive agent applied over at least a portion of the outer surface of the core.

11. The method of claim 10, wherein the coating layer is provided on a portion of the outer surface of the core.

12. The method of claim 10, wherein the coating layer is provided on an intermediate portion of the core.

13. The method of claim 10, wherein the core is selected from titanium alloys, nickel-cobalt base alloys, stainless steel, cobalt-chromium alloys, and biodegradable magnesium alloys.

14. The method of claim 10, wherein the polymer matrix comprises a first polymer and a second polymer wherein the first polymer is a poly(alkyl(meth)acrylate) or a poly(aromatic(meth)acrylate) and wherein the second polymer is poly(ethylene-co-vinyl acetate).

15. The method of claim 1, wherein the sustained release delivery device of (A) comprises:

a nonlinear body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end,

wherein at least a portion of the body member deviates from the direction of extension,

and wherein the body member includes the one or more bioactive agents, and a polymer matrix.

16. The method of claim 15, wherein the body member is coil-shaped.

17. The method of claim 15, wherein the body member includes a lumen.

18. The method of claim 15, wherein the polymer matrix comprises a first polymer and a second polymer, wherein the first polymer is a poly(alkyl(meth)acrylate) or a

poly(aromatic(meth)acrylate), and wherein the second polymer is poly(ethylene-co-vinyl acetate).

19. The method of claim 1, wherein method (C) comprises injecting one or more bioactive agents into the vitreous humor or comprises delivering one or more bioactive agents into the vitreous humor using iontophoresis.

20. The method of claim 1, wherein the one or more bioactive agents are selected from antiproliferative agents, anti-inflammatory agents, inhibitors of angiogenesis, antibiotics, hormonal agents, neurotropic factors, or combinations thereof.