Intrascleral drug delivery device and associated methods

Abstract

The present invention provides methods and devices for delivering an active agent into the eye of a subject. In one aspect, for example, the present invention provides an ocular drug delivery device including a housing configured to couple to the eye of the subject and a corneal seal coupled to the housing and positioned in the housing to encircle the cornea during use to form a corneal region, where the housing extends outward from the corneal seal to form a scleral region, and where the scleral region being positioned over the eye's sclera during use. The device further includes an active agent reservoir coupled to the housing and positioned to release active agent into the scleral region and a pressure regulator coupled to the housing that is operable to introduce negative pressure between the housing and the eye. Thus the corneal seal is operable to fluidically isolate the corneal region from the scleral region in response to the negative pressure.

What is claimed is: 
     
         1 . An ocular active agent delivery device, comprising:
 a housing including a corneal region and a scleral region configured to couple to an eye of a subject;   the corneal region comprising a corneal seal coupled to the housing and positioned in the housing to encircle a cornea of the eye during use, and to form the corneal region lacking a reservoir containing either an active agent or secondary compound therein;   the scleral region comprising at least one active agent reservoir positioned to release active agent into the scleral region, wherein the scleral region is configured to be positioned over a sclera of the eye during use; and   a pressure regulator coupled to the housing and operable to introduce negative pressure between the housing and the eye within the corneal region, wherein the corneal seal is operable to fluidically isolate the corneal region from the scleral region in response to the negative pressure.   
     
     
         2 . The device of  claim 1 , wherein the pressure regulator is operable to introduce positive pressure between the housing and the corneal region of eye to facilitate release of the housing from the eye. 
     
     
         3 . The device of  claim 1 , wherein the pressure regulator is a vacuum bulb. 
     
     
         4 . The device of  claim 1 , wherein the pressure regulator is removably coupled to the housing. 
     
     
         5 . The device of  claim 1 , further comprising a scleral seal coupled to the housing and positioned in the housing to encircle the corneal seal, the scleral region being between the corneal seal and the scleral seal. 
     
     
         6 . The device of  claim 5 , wherein the scleral seal has a structure that is operable to preclude lachrymal fluid from entering the scleral region. 
     
     
         7 . The device of  claim 5 , wherein the scleral seal is an outer edge of the housing. 
     
     
         8 . The device of  claim 5 , wherein the pressure regulator is positioned in the housing to introduce the negative pressure into the scleral region. 
     
     
         9 . The device of  claim 1 , further comprising a corneal cover coupled to the housing and extending inward from the corneal seal to completely cover the cornea during use. 
     
     
         10 . The device of  claim 1 , wherein the pressure regulator is positioned in the housing to introduce the negative pressure into the corneal region. 
     
     
         11 . The device of  claim 1 , further comprising an anode and a cathode both positioned to be facing the eye and at least one of the anode and cathode being in fluid communication with the active agent reservoir during use. 
     
     
         12 . The device of  claim 11 , wherein the anode and cathode are positioned so as to have an inter-electrode distance of from about 1 mm to about 10 mm. 
     
     
         13 . The device of  claim 1 , wherein the pressure regulator is oriented off-center from a center of the housing and in fluid communication with the corneal region. 
     
     
         14 . The device of  claim 13 , wherein negative pressure is applied between the housing and the eye in the scleral region. 
     
     
         15 . The device of  claim 1 , wherein the active agent reservoir has a surface area that is equal to 75% of the scleral region. 
     
     
         16 . The device of  claim 1 , wherein the active agent reservoir has a surface area that is equal to 10% of the scleral region. 
     
     
         17 . The device of  claim 1 , wherein the reservoir comprises an access port to allow the reservoir to be filled. 
     
     
         18 . The device of  claim 1 , wherein the pressure regulator is coupled to a pressure delivering channel that is operatively coupled to the corneal region. 
     
     
         19 . The device of  claim 1 , further comprising a power supply. 
     
     
         20 . A method of delivering an active agent to an eye of a subject while limiting the active agent from contacting an outer surface of a cornea during delivery, comprising:
 positioning the device of  claim 1  on the eye of the subject;   applying negative pressure between the housing and the eye to fluidically isolate the corneal region from the scleral region; and   delivering an active agent to the scleral region, such that the active agent is substantially precluded from entering the corneal region by the corneal seal.