Devices for drug delivery to ocular tissue using microneedle

Abstract

Methods and devices are provided for targeted administration of a drug to a patient's eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.

We claim: 
     
         1 . A device for administration of a therapeutic agent to the eye of a patient, comprising:
 a hollow microneedle having a tip end and a bore through which the therapeutic agent can be communicated through the microneedle; and   a device body for holding the microneedle, the device body having an end serving as a base from which the microneedle extends, wherein the base has a convex shape,   wherein the device is configured for insertion of the tip end of the microneedle into an insertion site in the eye and the device is operable to infuse the therapeutic agent into the retina or the subretinal space.   
     
     
         2 . The device of  claim 1 , further comprising an actuator for controlled infusion of the therapeutic agent through the microneedle. 
     
     
         3 . The device of  claim 1 , wherein the microneedle has an effective length between 500 microns and 2000 microns. 
     
     
         4 . The device of  claim 1 , wherein the device is operable to provide controlled infusion of from 10 μL to 200 μL of a fluid formulation comprising the therapeutic agent. 
     
     
         5 . The device of  claim 4 , wherein the device is operable to infuse the fluid formulation at a pressure of at least 150 kPa. 
     
     
         6 . The device of  claim 1 , further comprising a fluid reservoir for containing a fluid formulation comprising the therapeutic agent, wherein the fluid reservoir is in operable communication with the bore of the microneedle at the base. 
     
     
         7 . The device of  claim 1 , wherein the therapeutic agent comprises an anti-inflammatory agent. 
     
     
         8 . The device of  claim 1 , wherein the therapeutic agent comprises a steroidal compound. 
     
     
         9 . The device of  claim 8 , wherein the steroidal compound is betamethasone, clobetasone, dexamethasone, fluorometholone, hydrocortisone or prednisolone. 
     
     
         10 . The device of  claim 1 , wherein the therapeutic agent comprises pegagtanib sodium, ranibizumab or bevacizumab. 
     
     
         11 . The device of  claim 1 , wherein the therapeutic agent comprises an integrin antagonist, a selectin antagonist, an adhesion molecule antagonist, or a growth factor antagonist. 
     
     
         12 . The device of  claim 11 , wherein the growth factor antagonist is a vascular endothelial growth factor (VEGF) antagonist. 
     
     
         13 . The device of  claim 1 , wherein the therapeutic agent comprises a gene-based therapy. 
     
     
         14 . The device of  claim 13 , wherein the gene-based therapy comprises DNA, RNA, or oligonucleotides. 
     
     
         15 . The device of  claim 14 , wherein the gene-based therapy comprises dsRNA, siRNA, RNAi, an antisense oligonucleotide agent, or ribozymes. 
     
     
         16 . The device of  claim 13 , wherein the gene-based therapy is delivered to the eye in a vector.