Claims for Patent: 9,636,332

Summary for Patent: 9,636,332

Title:	Methods and devices for the treatment of ocular diseases in human subjects
Abstract:	Methods and devices are provided for targeted non-surgical administration of a drug formulation to the suprachoroidal space (SCS) of the eye of a human subject for the treatment of a posterior ocular disorder or a choroidal malady. In one embodiment, the method comprises inserting a hollow microneedle into the eye at an insertion site and infusing a drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. In one embodiment, the fluid drug formulation comprises drug nanoparticles or microparticles.
Inventor(s):	Zarnitsyn; Vladimir (Atlanta, GA), Patel; Samirkumar (Atlanta, GA), White; Daniel (Suwanee, GA), Noronha; Glenn (Atlanta, GA), Burke; Brian (Cary, NC)
Assignee:	CLEARSIDE BIOMEDICAL, INC. (Alpharetta, GA)
Application Number:	15/001,610
Patent Claims:	1. A method of treating uveitis in a human subject in need thereof, the method comprising, non-surgically administering an effective amount of a drug formulation comprising triamcinolone to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment of the uveitis, wherein upon administration, the drug formulation flows away from the insertion site and is substantially localized to the posterior segment of the eye. 2. The method of claim 1, wherein the uveitis is acute posterior uveitis. 3. The method of claim 1, wherein the effective amount of the drug formulation sufficient to elicit a therapeutic response when administered to the SCS is less than the effective amount of the drug formulation sufficient to elicit a therapeutic response when administered intravitreally, intracamerally, topically, parenterally or orally. 4. The method of claim 1, wherein the retention of the anti-inflammatory drug formulation in the posterior segment of the eye is greater than the retention of the drug formulation in the posterior segment of the eye when the drug formulation is administered intravitreally, intracamerally, topically, parenterally or orally. 5. The method of claim 1, wherein an intraocular C.sub.max of the drug formulation is greater than an intraocular C.sub.max of the drug formulation, when the drug formulation is administered intravitreally, intracamerally, topically, parenterally or orally. 6. The method of claim 1, wherein the systemic exposure of the drug formulation is less than the systemic exposure of the drug formulation when the drug formulation is administered intravitreally, intracamerally, topically, parenterally or orally. 7. The method of claim 1, wherein the non-surgically administering includes conveying the effective amount of the drug formulation to the SCS via a microneedle having a length of from about 500 .mu.m to about 1500 .mu.m. 8. The method of claim 1, wherein the drug formulation comprises a suspension of microparticles or nanoparticles. 9. The method of claim 1, wherein the drug formulation is triamcinolone acetonide. 10. The method of claim 1, wherein the intraocular pressure of the eye of the subject varies by no more than about 10% during the administration of the drug formulation. 11. The method of claim 3, wherein a dosage of the drug sufficient to elicit a therapeutic response when administered to the SCS is 50% or less of a dosage of the drug sufficient to elicit a therapeutic response when administered intravitreally, intracamerally, topically, parenterally or orally. 12. The method of claim 8, wherein the microparticles have a D.sub.50 of 2 .mu.m or less. 13. A method of treating uveitis in a human subject in need thereof, the method comprising, non-surgically administering an effective amount of a drug formulation comprising triamcinolone to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment of the uveitis. 14. The method of claim 13, wherein the uveitis is acute posterior uveitis. 15. The method of claim 13, wherein the drug formulation comprises a suspension of microparticles or nanoparticles. 16. The method of claim 13, wherein the drug formulation is triamcinolone acetonide. 17. The method of claim 13, wherein the effective amount of the drug formulation sufficient to elicit a therapeutic response when administered to the SCS is less than the effective amount of the drug formulation sufficient to elicit a therapeutic response when administered intravitreally, intracamerally, topically, parenterally or orally.