DRUG ELUTING OCULAR IMPLANT

• US 20120078362A1
• Filed: 05/18/2010
• Published: 03/29/2012
• Est. Priority Date: 05/18/2009
• Status: Abandoned Application

• Current Assignee: DOSE Medical Corporation (Glaukos Corporation)
• Original Assignee: DOSE Medical Corporation (Glaukos Corporation)
• Inventors: Haffner, David, Heitzmann, Harold, Curry, Ken, Applegate, David
• Application Number:
  US13/321,144
• Publication Number:
  US 20120078362A1
• Time in Patent Office: Days
• US Class Current: 623/6.13
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The devices are capable of controlled release of one or more drugs and may also include structures which allows for treatment of increased intraocular pressure by permitting aqueous humor to flow out of the anterior chamber of the eye through the device.

Claims

1. A drug delivery ocular implant comprising:

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

at least a first drug positioned within said interior lumen;

wherein said outer shell comprises a substantially uniform first thickness;

wherein said outer shell is permeable or semi-permeable to said drug, thereby allowing at least about 5% of total the elution of the drug to occur through the portions of the shell having said first thickness; and

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

2. The implant of claim 1, wherein said one or more regions of drug release are configured to allow a different rate of drug elution as compared to said elution through the outer shell.

3. The implant of claim 1, wherein the overall rate of elution of drug out of the implant is greater in the distal region of the implant.

4. The implant of claim 1, wherein there is a greater amount of the first drug in the distal half of the device as compared to the proximal half of the device.

5. The implant of claim 1, wherein the one or more regions of drug release are configured to allow a greater rate of drug elution as compared to said elution through the outer shell.

6. The implant of claim 1;

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

7. The implant of claim 6, wherein one or more regions of drug release comprise one or more orifices passing through the outer shell, and wherein said orifices are positioned along the long axis of the implant shell.

8. The implant of claim 1, wherein the drug is a steroid and the outer shell comprises silicone or siliconized polyurethane.

9. The implant of claim 8, wherein said outer shell comprises siliconized urethane and wherein said outer shell does not have any orifices passing through the outer shell.

10. The implant of claim 8, wherein the outer shell comprises silicone and the implant has one or more orifices passing through the outer shell.

11. The implant of claim 1, additionally comprising one or more coatings that alter the rate of drug elution from the implant.

12. The implant of claim 1, wherein at least the distal-most about 5 mm to about 10 mm of said interior lumen houses said drug.

13. The implant of claim 1, wherein said outer shell has a length between about 10 mm and about 20 mm, an outer diameter between about 150 microns to about 500 microns, and an interior lumen diameter of about 75 microns to about 475 microns.

14. The implant of claim 1, wherein the elution of said drug from said implant continues for at least a period of at least one year.

15. The implant of claim 1, further comprising a lumen configured to transport ocular fluid from a first location in an eye to one or more other locations, thereby reducing intraocular pressure.

16. A method of treating an ocular condition or disorder in an intraocular target tissue comprising:

making an incision in the temporal portion of the eye,

advancing a delivery device associated with a drug delivery implant through the cornea of the eye and across the anterior chamber of the eye,

inserting the drug delivery implant into the suprachoroidal space of the eye,

wherein the drug delivery implant comprises,

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

at least a first drug positioned within said interior lumen;

wherein said outer shell comprises a substantially uniform first thickness;

wherein said outer shell is permeable or semi-permeable to said drug, thereby allowing at least about 5% of total the elution of the drug to occur through the portions of the shell having said first thickness; and

.

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

positioning said implant such that at least one of said one or more regions of drug release are located proximate an intraocular target; and

withdrawing the delivery device from the eye, wherein drug elutes from the implant in sufficient quantity to treat an ocular condition or disorder.

17. The method of claim 16, wherein the intraocular target is in the posterior chamber of the eye.

18. The method of claim 16, wherein the intraocular target is selected from the group consisting of the macula, the retina, the optic nerve, the ciliary body, and the intraocular vasculature.

19. The method of claim 16, wherein the drug elutes from the implant so as to achieve a therapeutic effect for a period of at least one year.

20. The method of claim 16, wherein the implant further comprises a shunt configured to transport ocular fluid from the anterior chamber to one or more physiological outflow pathways, thereby reducing intraocular pressure.

21. The method of claim 16, wherein the drug is a steroid and wherein said implant contains a total load of steroid ranging from about 10 to about 1000 micrograms.

23. The method of claim 21, wherein said steroid is released from said implant at a rate ranging from about 0.05 to about 10 micrograms per day thereby achieving a concentration at said target tissue ranging from about 1 to about 100 nanomolar.

22. (canceled)

24. (canceled)