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.

1 . A method of treating a posterior ocular disorder in a human subject in need thereof, the method comprising,
 non-surgically administering an effective amount of a drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment of the posterior ocular disorder,   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 administering step comprises inserting a hollow microneedle into the sclera at an insertion site, the microneedle having a tip end with an opening and infusing the drug formulation into the SCS through the inserted microneedle. 
     
     
         3 . The method of  claim 2 , wherein the insertion site is at about the equator of the eye, or between the equator and the limbus of the eye. 
     
     
         4 . The method of  claim 2 , wherein the microneedle has a length of from about, 500 μm and about 1500 μm. 
     
     
         5 . The method of  claim 2 , wherein the microneedle has a diameter of from about 200 μm to about 600 μm. 
     
     
         6 . The method of  claim 2 , wherein the microneedle has a bevel angle of about 5 degrees to about 30 degrees. 
     
     
         7 . The method of  claim 2 , wherein the bevel height is from about 100 μm to about 500 μm. 
     
     
         8 . The method of  claim 2 , wherein the microneedle is inserted into the sclera without penetrating through the sclera. 
     
     
         9 . The method of  claim 2 , wherein the microneedle is inserted into the sclera without penetrating through the choroid. 
     
     
         10 .- 109 . (canceled) 
     
     
         110 . A method for treating a choroidal malady in a human patient, the method comprising: non-surgically administering a drug formulation comprising an effective amount of an anti-inflammatory drug, a vascular endothelial growth factor (VEGF) modulator, a platelet derived growth factor (PDGF) modulator, an angiogenesis inhibitor, an immunosuppressive agent, a vascular permeability inhibitor, or a combination thereof, to the suprachoroidal space (SCS) of the eye of the patient. 
     
     
         111 .- 229 . (canceled) 
     
     
         230 . A pharmaceutical composition comprising triamcinolone particles having a D 50  of less than 3 μm. 
     
     
         231 .- 241 . (canceled)