Punctal implants with controlled drug delivery features and methods of using same

Abstract

Disclosed herein are drug delivery punctal implants and methods of using the implants for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The physical arrangement of drugs within the punctal plugs disclosed herein results, in several embodiments, in advantageous controlled delivery of one or more drugs to the eye of a patient.

1 . (canceled) 
     
     
         2 . A punctal implant for insertion into a punctum of the eye of a subject, the implant comprising:
 an outer shell comprising:
 a first end comprising a plurality of holes or fenestrations, 
 a closed second end; 
 an interior lumen extending from the first end to the closed second end; and 
   a first drug and a second drug within the interior lumen, wherein the first and second drugs are individually shaped into tablets, wherein the tablets are sized and physically arranged within the interior lumen to allow the first drug to be closer to the region of drug release and initially elute prior to an initial elution of the second drug, and   wherein the first drug and the second drug elute from the lumen by passing through the plurality of holes or fenestrations.   
     
     
         3 . The implant of  claim 2 , further comprising at least one retention feature configured to anchor the implant in the punctum. 
     
     
         4 . The implant of  claim 3 , wherein the at least one retention feature is non-occlusive. 
     
     
         5 . The implant of  claim 2 , further comprising an asymmetrical flange having a length extending in a first direction that exceeds a width extending in a second direction. 
     
     
         6 . The implant of  claim 5 , wherein the asymmetrical flange is configured to rest on the surface of the eyelid when the implant is inserted into the punctum. 
     
     
         7 . The implant of  claim 2 , wherein the first drug is shaped into a first tablet and the second drug is shaped into a second tablet, the first tablet positioned atop the second tablet. 
     
     
         8 . The implant of  claim 2 , wherein each of the plurality of holes or fenestrations have a diameter that is less than a diameter of the lumen. 
     
     
         9 . The implant of  claim 2 , wherein the outer shell comprises a radial bulge in a distal region in order to anchor the implant in the punctum. 
     
     
         10 . The implant of  claim 9 , wherein a width of the radial bulge gradually increases to a maximum width and gradually decreases from the maximum width. 
     
     
         11 . The implant of  claim 2 , wherein the outer shell has an outer diameter that gradually increases to a maximum outer diameter in a distal region and wherein the outer diameter gradually decreases between the maximum outer diameter and the closed second end. 
     
     
         12 . A punctal implant for insertion into a punctum of the eye of a subject, the implant comprising:
 an outer shell comprising:
 a first end comprising a plurality of holes or fenestrations; and 
 an interior lumen extending from the first end to a second end; and 
   a first tablet comprising a first drug and a second tablet comprising a second drug positioned within the interior lumen, the first tablet positioned atop the second tablet, and   wherein the first and second drug elute from the lumen by passing through the plurality of holes or fenestrations.   
     
     
         13 . The implant of  claim 12 , further comprising at least one retention feature configured to anchor the implant in the punctum. 
     
     
         14 . The implant of  claim 13 , wherein the at least one retention feature is non-occlusive. 
     
     
         15 . The implant of  claim 12 , further comprising an asymmetrical flange having a length extending in a first direction that exceeds a width extending in a second direction. 
     
     
         16 . The implant of  claim 15 , wherein the asymmetrical flange is configured to rest on the surface of the eyelid when the implant is inserted into the punctum. 
     
     
         17 . The implant of  claim 12 , wherein each of the plurality of holes or fenestrations have a diameter that is less than a diameter of the lumen. 
     
     
         18 . The implant of  claim 12 , wherein the second end is a closed second end. 
     
     
         19 . The implant of  claim 12 , wherein the outer shell comprises a radial bulge in a distal region in order to anchor the implant in the punctum. 
     
     
         20 . The implant of  claim 19 , wherein a width of the radial bulge gradually increases to a maximum width and gradually decreases from the maximum width. 
     
     
         21 . The implant of  claim 20 , wherein the outer shell has an outer diameter that gradually increases to a maximum outer diameter in a distal region and wherein the outer diameter gradually decreases between the maximum outer diameter and the closed second end.