Ophthalmic system for sustained release of drug to eye

Abstract

Disclosed is an ocular device including a first structure formed of a first material providing a first shape to the ocular device prior to positioning the ocular device on the surface of the eye, a second structure formed of a second, different material having a tubular structure and a lumen through which the first structure extends, and at least one therapeutic agent is dispersed within the second material of the second structure. The first shape of the ocular device conforms to a second, different shape after positioning the ocular device on the surface of the eye. Upon being removed from the eye, the ocular device retains the second shape or changes to a third shape different from both the first shape and the second shape. Related apparatus, systems and method are described.

1 .- 52 . (canceled) 
     
     
         53 . An ocular device configured to be positioned on an anterior surface of the eye at least partially underneath at least one of the upper and lower eyelids and outside a cornea of the eye, the ocular device comprising:
 a support structure having a ring shape; and   first and second cylindrical tubes of molded silicone matrix, each of the first and second cylindrical tubes defining a lumen extending from a first end to a second end of the cylindrical tube, the lumen sized to receive the support structure, wherein the first and second ends of the first cylindrical tube abuts the first and second ends of the second cylindrical tube such that the support structure is fully encapsulated by the first and second cylindrical tubes,   wherein the first and second cylindrical tubes of molded silicone matrix comprise at least one therapeutic agent configured to be delivered to the eye.   
     
     
         54 . The ocular device of  claim 53 , wherein the ocular device comprises a pre-insertion shape prior to positioning the ocular device on the surface of the eye, wherein the pre-insertion shape of the ocular device conforms to a second, different shape after positioning the ocular device on the surface of the eye, and wherein upon being removed from the eye, the ocular device retains the second shape or changes to a third shape, wherein the third shape is different from both the pre-insertion shape and the second shape. 
     
     
         55 . The ocular device of  claim 54 , wherein the ocular device resists deflection away from the second shape upon being removed from the eye. 
     
     
         56 . The ocular device of  claim 54 , wherein the pre-insertion shape is an annular shape positioned substantially within a first plane and the second and third shapes are positioned at least partially outside of the first plane. 
     
     
         57 . The ocular device of  claim 53 , wherein the first cylindrical tube of silicone matrix is formulated to release the at least one therapeutic agent and wherein the second cylindrical tube of silicone matrix is formulated to release the at least one therapeutic agent or a second, different therapeutic agent. 
     
     
         58 . The ocular device of  claim 57 , wherein the first and second cylindrical tubes of silicone matrix are formulated to release the at least one therapeutic agents at different doses. 
     
     
         59 . The ocular device of  claim 58 , wherein the first cylindrical tube of silicone matrix is formulated to release the at least one therapeutic agent at a first higher drug dose for a first period of time and wherein the second cylindrical tube of silicone matrix is formulated to release the at least one therapeutic agent at a second lower drug dose for a second longer period of time. 
     
     
         60 . The ocular device of  claim 53 , wherein the support structure comprises a suture material, the suture material comprising nylon, polymethyl methacrylate (PMMA), polycarbonate, polyethylene terephthalate, or polypropylene suture material. 
     
     
         61 . The ocular device of  claim 60 , wherein the suture material has a USP suture size from USP #0, #2-0, #3-0, #4-0, #5-0, or #6-0. 
     
     
         62 . The ocular device of  claim 53 , wherein the ocular device has a diameter across an opening of the ring shape that is between about 24 mm to about 29 mm, and wherein each of the first and second cylindrical tubes of molded silicone matrix has a cross-sectional diameter that is between about 0.5 mm to about 1.5 mm. 
     
     
         63 . The ocular device of  claim 62 , wherein each of the first and second cylindrical tubes has a cross-sectional shape that is circular prior to insertion in the eye. 
     
     
         64 . The ocular device of  claim 53 , wherein the support structure has a self-loading resistance to deflection that is within a range from about 0.01 N/mm to about 1 N/mm. 
     
     
         65 . The ocular device of  claim 53 , wherein the support structure has a self-loading resistance to deflection having a deflection angle between a first portion of the device and a second portion of the device when the first portion is supported and held in place and a weight of the second portion deflects the device. 
     
     
         66 . The ocular device of  claim 65 , wherein at least one of the first and second cylindrical tubes has a self-loading resistance to deflection that is less than the self-loading resistance to deflection of the support structure. 
     
     
         67 . The ocular device of  claim 66 , wherein the deflection angle is between about 1 degree and about 60 degrees. 
     
     
         68 . The ocular device of  claim 53 , wherein the at least one therapeutic agent is for lowering the intraocular pressure of the eye. 
     
     
         69 . The ocular device of  claim 53 , wherein the at least one therapeutic agent is for treating dry eye. 
     
     
         70 . The ocular device of  claim 69 , wherein the at least one therapeutic agent is cyclosporine. 
     
     
         71 . The ocular device of  claim 53 , wherein the at least one therapeutic agent comprises a prostaglandin analogue. 
     
     
         72 . The ocular device of  claim 71 , wherein the prostaglandin analogue comprises at least one of bimatoprost, latanoprost, travoprost, and tafluprost.