Method for treating and/or preventing retinal diseases with sustained release corticosteroids

• US 8,252,307 B2
• Filed: 01/08/2010
• Issued: 08/28/2012
• Est. Priority Date: 03/22/1999
• Status: Expired due to Fees

• Current Assignee: EyePoint Pharmaceuticals, Inc.
• Original Assignee: pSivida US, Inc
• Inventors: Ashton, Paul
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/684,341
• Publication Number:
  US 20100168073A1
• Time in Patent Office: 963 Days
• Field of Search: None
• US Class Current: 424/427
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

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.

Claims

1. A sustained release device including fluocinolone acetonide (FA) disposed therein as the sole active agent, which device is dimensioned for implantation in the vitreal cavity of a patient'"'"'s eye and configured to have a release rate over a time course of at least 4 weeks after implantation, which release rate results in an aqueous humor FA concentration less than one tenth the vitreous FA concentration.

4. The device of any of claims 1-3, wherein the aqueous humor FA concentration is less than about 0.05 μ

g/ml.

5. The device of any of claims 1-3, wherein the FA is released with pseudo zero order kinetics.

6. The device of any of claims 1-3, configured to have a release rate for said FA over said time course.

7. The device of any of claims 1-3, wherein said time course is at least 100 days.

8. The device of claim 1 or 3, which release rate results in an aqueous humor FA concentration which does not cause an increase in intraocular pressure over said time course that could result in damage to a patient'"'"'s ocular tissue.

9. The device of claim 8, wherein the release rate for said FA over said time course is effective for reducing one or more of senile macular degeneration, chronic posterior or and pan uveitis, or diabetic macular edema.

10. The device of any of claims 1-3, which release rate does not produce ocular steroid-induced toxicity.

2. A sustained release device including FA disposed therein as the sole active agent, which device is dimensioned for implantation in the vitreal cavity of a patient'"'"'s eye and configured to have a release rate for said FA to produce a sustained and therapeutic concentration of said FA over a time course of at least 4 weeks effective for reducing neovascularization, edema, diabetic retinopathy, retinal detachment, sickle cell retinopathy, senile macular degeneration, retinal neovascularization, subretinal neovascularization, chronic posterior and pan uveitis, neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, or neovascularization due to penetration of the eye or ocular injury, which release rate results in an aqueous humor FA concentration which does not cause an increase in intraocular pressure over said time course that could result in damage to a patient'"'"'s ocular tissue.

11. The device of claim 2 or 3, which device is effective for reducing senile macular degeneration, chronic posterior or pan uveitis, or diabetic macular edema.

3. A sustained release device including FA disposed therein as the sole active agent, which device is dimensioned for implantation in the vitreal cavity of a patient'"'"'s eye and configured to have a release rate for said FA to produce a sustained and therapeutic concentration of said FA over a time course of at least 4 weeks effective for reducing neovascularization, edema, or diabetic retinopathy, retinal detachment, sickle cell retinopathy, senile macular degeneration, retinal neovascularization, subretinal neovascularization, chronic posterior and pan uveitis, neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, or neovascularization due to penetration of the eye or ocular injury, which release rate results in an aqueous humor FA concentration less than one tenth the vitreous FA concentration.

12. A sustained release device including a steroid disposed therein as the sole active agent, which device is dimensioned for implantation in the vitreal cavity of a patient'"'"'s eye and configured to release a therapeutically effective amount of steroid, which amount does not produce ocular or systemic steroid-induced toxicity.

14. The device of claim 12 or 13, wherein the steroid is released with pseudo zero order kinetics.

13. A sustained release device including a steroid disposed therein as the sole active agent, which device is dimensioned for implantation in the posterior segment of a patient'"'"'s eye and configured to release a therapeutically effective amount of steroid, which amount does not produce ocular or systemic steroid-induced toxicity.

15. A sustained release device including FA disposed therein as the sole active agent, which device is dimensioned for implantation in the posterior segment of a patient'"'"'s eye and configured to have a release rate over a time course of at least 4 weeks after implantation, which release rate results in an aqueous humor FA concentration less than one tenth the vitreous FA concentration.

18. The device of any of claims 15-17, wherein the aqueous humor FA concentration is less than about 0.05 μ

g/ml.

19. The device of any of claims 15-17, wherein the FA is released with pseudo zero order kinetics.

20. The device of any of claims 15-17, configured to have a release rate for said FA over said time course.

21. The device of any of claims 15-17, wherein said time course is at least 100 days.

22. The device of claim 15 or 17, which release rate results in an aqueous humor FA concentration which does not cause an increase in intraocular pressure over said time course that could result in damage to a patient'"'"'s ocular tissue.

23. The device of claim 22, wherein the release rate for said FA over said time course is effective for reducing one or more of senile macular degeneration, chronic posterior or and pan uveitis, or diabetic macular edema.

24. The device of any of claims 15-17, which release rate does not produce ocular steroid-induced toxicity.

16. A sustained release device including FA disposed therein as the sole active agent, which device is dimensioned for implantation in the posterior segment of a patient'"'"'s eye and configured to have a release rate for said FA to produce a sustained and therapeutic concentration of said FA over a time course of at least 4 weeks effective for reducing neovascularization, edema, diabetic retinopathy, retinal detachment, sickle cell retinopathy, senile macular degeneration, retinal neovascularization, subretinal neovascularization, chronic posterior and pan uveitis, neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, or neovascularization due to penetration of the eye or ocular injury, which release rate results in an aqueous humor FA concentration which does not cause an increase in intraocular pressure over said time course that could result in damage to a patient'"'"'s ocular tissue.

25. The device of claim 16 or 17, which device is effective for reducing senile macular degeneration, chronic posterior or pan uveitis, or diabetic macular edema.

17. A sustained release device including FA disposed therein as the sole active agent, which device is dimensioned for implantation in the posterior segment of a patient'"'"'s eye and configured to have a release rate for said FA to produce a sustained and therapeutic concentration of said FA over a time course of at least 4 weeks effective for reducing neovascularization, edema, diabetic retinopathy, retinal detachment, sickle cell retinopathy, senile macular degeneration, retinal neovascularization, subretinal neovascularization, chronic posterior and pan uveitis, neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, or neovascularization due to penetration of the eye or ocular injury, which release rate results in an aqueous humor FA concentration less than one tenth the vitreous FA concentration.