Anterior chamber drug-eluting ocular implant

• US 10,245,178 B1
• Filed: 06/06/2012
• Issued: 04/02/2019
• Est. Priority Date: 06/07/2011
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Heitzmann, Harold, Tasso, Vanessa
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R
• Application Number:
  US13/490,346
• Time in Patent Office: 2,491 Days
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/00 Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Disclosed herein are drug delivery ocular implants comprising an elongate outer shell having a proximal end, and distal end and being shaped to define an interior lumen, at least one therepautic agent positioned within the lumen, wherein the outer shell has at least a first thickness, the outer shell comprises one or more regions of drug release, and the implant is dimensioned for implantation within the anterior chamber of the eye.

Claims

1. A drug delivery ocular implant comprising:

an elongate outer shell having a proximal end, and a distal end, and being shaped to define an interior space;

at least one drug positioned within said interior space;

wherein said outer shell has at least a first thickness and an outer diameter;

wherein said outer shell comprises one or more regions of drug release;

wherein said implant is shaped and sized so as to be suitable for implantation within an anterior chamber of an eye;

wherein said implant is shaped and sized to be positioned fully in an irido-corneal angle of the anterior chamber of the eye;

wherein said implant is configured without one or more anchoring protrusions, wherein the outer shell provides sufficient friction against tissue of the irido-corneal angle to hold the implant in position in the irido-corneal angle; and

wherein said implant is configured to be deformed from a straightened to an arcuate shape for retention within the irido-corneal angle.

2. The implant of claim 1, wherein said implant is biodegradable.

3. The implant of claim 1, wherein said outer shell comprises a non-rigid polymer selected from the group consisting of silicone elastomer, polyurethane, and silicone-polyurethane co-polymer.

4. The implant of claim 1, wherein said at least one drug acts on therapeutic targets in the anterior chamber of the eye, and wherein said at least one drug comprises one or more of prostaglandins, prostaglandin analogs, alpha-blockers, beta-blockers, and combinations thereof.

5. The implant of claim 4, wherein said therapeutic target is the ciliary body.

6. The implant of claim 4, wherein said at least one drug is selected from the group consisting of latanoprost, travoprost, timolol, and brimonidine.

7. The implant of claim 1, wherein said one or more regions of drug release are configured to modulate a release rate of the at least one drug from the interior space of said implant, and

wherein the one or more regions of drug release comprise one or more regions of reduced thickness outer shell material, one or more orifices passing through the outer shell, or combinations thereof.

8. The implant of claim 1, wherein said outer shell is semi-permeable to the at least one drug.

9. The implant of claim 1, wherein said at least one drug is configured to have a modulated release rate from the implant.

10. The implant of claim 1, wherein said at least one drug is compounded with an excipient that modulates elution of the drug into ocular fluid and/or blended or coated with a polymer that modulates elution of the drug into ocular fluid.

11. The implant of claim 1, wherein said at least one drug is formulated as one or more micro-tablets.

12. The implant of claim 11, wherein said at least one drug is present in an amount of at least 70% by weight of a total weight of the micro-tablet.

13. The implant of claim 11, wherein said micro-tablets have a surface area to volume ratio of about 13 to 17.

14. The implant of claim 11, wherein said micro-tablets are formed by utilizing one or more of processes selected from the group consisting of tabletting, lyophilization, granulation (wet or dry), flaking, direct compression, molding, and extrusion.

15. The implant of claim 11, wherein said micro-tablets are configured to balance osmotic pressure between said interior space and an ocular environment external to the implant after implantation.

16. A drug delivery ocular implant comprising:

an elongate polymeric body comprising an outer shell having a proximal end, and a distal end and being shaped to define an interior space;

at least one drug positioned within said interior space;

wherein said outer shell has at least a first thickness and an outer diameter;

wherein said outer shell comprises one or more regions of drug release;

wherein said implant is shaped and sized so as to be suitable for implantation within an anterior chamber of an eye;

wherein said implant is shaped and sized to be positioned fully in an irido-corneal angle of the anterior chamber of the eye and fully within the anterior chamber of the eye;

wherein said implant is configured with one or more anchoring protrusions, wherein the one or more anchoring protrusions hold the implant in position in the irido-corneal angle; and

wherein said implant is configured to be deformed from a straightened to an arcuate shape for retention within the irido-corneal angle.

17. The implant of claim 16, wherein the one or more anchoring protrusions includes a biodegradable retention protrusion.

18. The implant of claim 16, wherein the one or more anchoring protrusions includes one or more ridges formed along an outer surface of the outer shell.

19. The implant of claim 16, wherein the one or more anchoring protrusions includes an expandable material configured to expand radially outward from the outer shell.

20. The implant of claim 16, wherein said implant is biodegradable.

21. The implant of claim 16, wherein said outer shell comprises a non-rigid polymer selected from the group consisting of silicone elastomer, polyurethane, and silicone-polyurethane co-polymer.

22. The implant of claim 16, wherein said at least one drug acts on therapeutic targets in the anterior chamber of the eye, and wherein said at least one drug comprises one or more of prostaglandins, prostaglandin analogs, alpha-blockers, beta-blockers, and combinations thereof.

23. The implant of claim 22, wherein said at least one drug is selected from the group consisting of latanoprost, travoprost, timolol, and brimonidine.

24. The implant of claim 16, wherein said one or more regions of drug release are configured to modulate a release rate of the at least one drug from the interior space of said implant, and

wherein the one or more regions of drug release comprise one or more regions of reduced thickness outer shell material, one or more orifices passing through the outer shell, or combinations thereof.

25. The implant of claim 16, wherein said at least one drug is compounded with an excipient that modulates elution of the drug into ocular fluid and/or blended or coated with a polymer that modulates elution of the drug into ocular fluid.

26. A drug delivery ocular implant comprising:

an elongate polymeric body comprising a proximal end and a distal end, a polymer, and at least one drug blended with the polymer of the elongate polymeric body;

wherein said elongate polymeric body is biodegradable;

wherein the at least one drug comprises one or more of travoprost or dexamethasone;

wherein said implant is shaped and sized so as to be suitable for implantation within an anterior chamber of an eye;

wherein said implant is shaped and sized to be positioned fully in an irido-corneal angle and fully within the anterior chamber of the eye;

wherein said polymeric body provides sufficient friction against tissue of the irido-corneal angle to hold the implant in position in the irido-corneal angle; and

wherein said implant is configured to be deformed from a straightened to an arcuate shape for retention within the irido-corneal angle.

27. The implant of claim 26, wherein said polymer of the elongate polymeric body comprises a non-rigid polymer selected from the group consisting of silicone elastomer, polyurethane, and silicone-polyurethane co-polymer.

28. The implant of claim 26, wherein said at least one drug acts on therapeutic targets in the anterior chamber of the eye, and wherein said at least one drug further comprises one or more of prostaglandins, prostaglandin analogs, alpha-blockers, beta-blockers, and combinations thereof.

29. The implant of claim 28, wherein said therapeutic target is the ciliary body.

30. The implant of claim 26, further comprising an outer shell having one or more regions of drug release, said one or more regions of drug release configured to modulate a release rate of the at least one drug from said implant, and

wherein the one or more regions drug release comprise one or more of regions of reduced thickness outer shell material, one or more orifices passing through the outer shell, or combinations thereof.

31. The implant of claim 26, wherein said at least one drug is configured to have a modulated release rate from the implant.

32. The implant of claim 26, wherein said implant is configured with one or more anchoring protrusions.