Claims for Patent: 6,548,078

Summary for Patent: 6,548,078

Title:	Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Abstract:	The present invention relates to a method for administering a corticosteroid to a posterior segment of an eye. In the method, a sustained release device is implanted to deliver the corticosteroid to the eye. The aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during release of the corticosteroid from the device.
Inventor(s):	Guo; Hong (Belmont, MA), Ashton; Paul (Boston, MA)
Assignee:	Control Delivery Systems (Watertown, MA)
Application Number:	09/735,636
Patent Claims:	1. A method for administering a steroid to a posterior segment of eye, the method comprising the step of: implanting a sustained release device to deliver the steroid to the vitreous of the eye and wherein aqueous steroid concentration is less than vitreous steroid concentration during release. 2. A method according to claim 1, wherein aqueous steroid concentration is about 0.002 .mu.g/ml to about 0.01 .mu.g/ml. 3. A method according to claim 2, wherein aqueous steroid concentration is about 0.01 .mu.g/ml to about 0.02 .mu.g/ml. 4. A method according to claim 1, wherein aqueous steroid concentration is less than 0.02 .mu.g/ml. 5. A method according to claim 1, wherein the device releases steroid for about 1 month to about 20 years. 6. A method according to claim 5, wherein the device releases steroid for about 6 months to about 5 years. 7. A method according to claim 1, wherein the vitreous steroid concentration is therapeutic. 8. A method according to claim 1, wherein the vitreous steroid concentration is less than about 10 .mu.g/ml. 9. A method according to claim 1, comprising intravitreally implanting the sustained release device. 10. A method according to claim 1, wherein a disease state to be treated is selected from the group consisting of ocular neovascularization, ocular inflammation and retinal degeneration. 11. A method according to claim 1, wherein the sustained release device releases the steroid with pseudo zero order kinetics. 12. A method according to claim 1, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of steroid. 13. A method according to claim 12, wherein sustained release device has a mean release rate of about 1 .mu.g/day to about 10 .mu.g/day of steroid. 14. A method according to claim 1, wherein the sustained release device releases only one drug. 15. An implantable, sustained release device for administering a steroid to a posterior segment of an eye, the device comprising: a steroid, wherein the device is configured to provide sustained release of the steroid to the vitreous of the eye such that aqueous steroid concentration remains less than vitreous steroid concentration during the release. 16. A device according to claim 15, wherein the device is configured to provide sustained release of the steroid to the vitreous of the eye such that aqueous steroid concentration remains less than vitreous steroid concentration during the release. 17. A device according to claim 15, wherein the sustained release device releases the steroid with pseudo zero order kinetics. 18. A device according to claim 15, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of steroid. 19. A device according to claim 15, wherein the sustained release device releases only one drug. 20. A method for administering a corticosteroid to a posterior segment of an eye, the method comprising the step of: implanting a sustained release device to deliver the corticosteroid to the posterior of the eye and wherein aqueous corticosteroid concentration is less than vitreous corticosteroid concentration during release. 21. A method according to claim 20, wherein aqueous corticosteroid concentration is about 0.002 .mu.g/ml to about 0.01 .mu.g/ml. 22. A method according to claim 21, wherein aqueous corticosteroid concentration is about 0.01 .mu.g/ml to about 0.02 .mu.g/ml. 23. A method according to claim 20, wherein aqueous corticosteroid concentration is less than 0.02 .mu.g/ml. 24. A method according to claim 20, wherein the device releases corticosteroid for about 1 month to about 20 years. 25. A method according to claim 24, wherein the device releases corticosteroid for about 6 months to about 5 years. 26. A method according to claim 20, wherein the vitreous corticosteroid concentration is therapeutic. 27. A method according to claim 20, wherein the vitreous corticosteroid concentration is less than about 10 .mu.g/ml. 28. A method according to claim 20, wherein the steroid is a corticosteroid and is selected from the group consisting of triamcinolone, dexamethasone, fluocinolone, cortisone, prednisolone, flumetholone, and derivatives thereof. 29. A method according to claim 20, comprising intravitreally implanting the sustained release device. 30. A method according to claim 20, wherein a disease state to be treated is selected from the group consisting of ocular neovascularization, ocular inflammation and retinal degeneration. 31. A method according to claim 20, wherein the sustained release device releases the corticosteroid with pseudo zero order kinetics. 32. A method according to claim 20, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of corticosteroid. 33. A method according to claim 32, wherein sustained release device has a mean release rate of about 1 .mu.g/day to about 10 .mu.g/day of corticosteroid. 34. A method according to claim 20, wherein the sustained release device releases only one drug. 35. An implantable, sustained release device for administering a corticosteroid to a posterior segment of an eye, the device comprising: a corticosteroid, wherein the device is configured to provide sustained release of the corticosteroid to the posterior of the eye such that aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during the release. 36. A device according to claim 35, wherein the device is configured to provide sustained release of the corticosteroid to the posterior of the eye such that aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during the release. 37. A device according to claim 35, wherein the steroid is a corticosteroid and is selected from the group consisting of triamcinolone, dexamethasone, fluocinolone, cortisone, prednisolone, flumetholone, and derivatives thereof. 38. A device according to claim 35, wherein the sustained release device releases the corticosteroid with pseudo zero order kinetics. 39. A device according to claim 35, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of corticosteroid. 40. A device according to claim 53, wherein the sustained release device releases only one drug. 41. A method for administering a steroid to a posterior segment of an eye, the method comprising the step of: implanting a sustained release device to deliver the steroid to the posterior of the eye and wherein aqueous steroid concentration is less than vitreous steroid concentration during release. 42. A method according to claim 41, wherein aqueous steroid concentration is about 0.002 .mu.g/ml to about 0.01 .mu.g/ml. 43. A method according to claim 42, wherein aqueous steroid concentration is about 0.01 .mu.g/ml to about 0.02 .mu.g/ml. 44. A method according to claim 41, wherein aqueous steroid concentration is less than 0.02 .mu.g/ml. 45. A method according to claim 41, wherein the device releases steroid for about 1 month to about 20 years. 46. A method according to claim 45, wherein the device releases steroid for about 6 months to about 5 years. 47. A method according to claim 41, Wherein the vitreous steroid concentration is therapeutic. 48. A method according to claim 41, wherein the vitreous steroid concentration is less than about 10 .mu.g/ml. 49. A method according to claim 41, wherein the steroid is a corticosteroid and is selected from the group consisting of triamcinolone, dexamethasone, fluocinolone, cortisone, prednisolone, flumetholone, and derivatives thereof. 50. A method according to claim 41, comprising intravitreally implanting the sustained release device. 51. A method according to claim 41, wherein a disease state to be treated is selected from the group consisting of ocular neovascularization, ocular inflammation and retinal degeneration. 52. A method according to claim 41, wherein the sustained release device releases the steroid with pseudo zero order kinetics. 53. A method according to claim 41, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of steroid. 54. A method according to claim 53, wherein sustained release device has a mean release rate of about 1 .mu.g/day to about 10 .mu.g/day of steroid. 55. A method according to claim 41, wherein the sustained release device releases only one drug. 56. An implantable, sustained release device for administering a steroid to a posterior segment of an eye, the device comprising: a steroid, wherein the device is configured to provide sustained release of the steroid to the posterior of the eye such that aqueous steroid concentration remains less than vitreous steroid concentration during the release. 57. A device according to claim 56, wherein the device is configured to provide sustained release of the steroid to the posterior of the eye such that aqueous steroid concentration remains less than vitreous steroid concentration during the release. 58. A device according to claim 56, wherein the steroid is a corticosteroid and is selected from the group consisting of triamcinolone, dexamethasone, fluocinolone, cortisone, prednisolone, flumetholone, and derivatives thereof. 59. A device according to claim 56, wherein the sustained release device releases the steroid with pseudo zero order kinetics. 60. A device according to claim 56, wherein the sustained release device has a mean release rate of about 1 .mu.g/day to about 50 .mu.g/day of steroid. 61. A device according to claim 56, wherein the sustained release device releases only one drug.