Apparatus and formulations for suprachoroidal drug delivery

Abstract

Drug formulations, devices and methods are provided to deliver biologically active substances to the eye. The formulations are delivered into scleral tissues adjacent to or into the suprachoroidal space without damage to the underlying choroid. One class of formulations is provided wherein the formulation is localized in the suprachoroidal space near the region into which it is administered. Another class of formulations is provided wherein the formulation can migrate to another region of the suprachoroidal space, thus allowing an injection in the anterior region of the eye in order to treat the posterior region.

1 . A method of administering drugs in the suprachoroidal space of the eye comprising the steps of placing a needle in scleral tissues toward the suprachoroidal space at a depth of at least half of the scleral thickness, and injecting a drug formulation through said needle into the sclera in close proximity to the inner boundary of the sclera such that said formulation dissects the scleral tissues adjacent to said suprachoroidal space and enters said suprachoroidal space. 
     
     
         2 . The method of  claim 1 , wherein said formulation enters said suprachoroidal space and flows toward the posterior region of said suprachoroidal space. 
     
     
         3 . A method for administering drugs to an eye comprising injection of a drug formulation into the suprachoroidal space, said drug formulation comprising a biologically active substance and a polymer excipient, wherein the drug formulation forms a layer between the choroid and sclera in the area of administration. 
     
     
         4 . The method according to  claim 3 , wherein said injection comprises injection through a needle. 
     
     
         5 . The method according to  claim 3 , wherein said biologically active substance comprises a steroid or non-steroidal anti-inflammatory agent to treat inflammation and edema. 
     
     
         6 . The method according to  claim 3  wherein said polymer excipient comprises a water soluble polymer. 
     
     
         7 . The method according to  claim 1 , wherein the placing of the needle tip is guided by imaging surrounding tissues. 
     
     
         8 . The method according to  claim 1 , wherein said needle comprises a sensor to guide the placement of the needle tip. 
     
     
         9 . A method for administering drugs to an eye comprising:
 injection of a drug formulation into the suprachoroidal space, said drug formulation comprising microspheres or microparticles with an outer diameter in the range of about 1 to 33 microns, and a polymer excipient,-wherein said microspheres or microparticles comprising a biologically active substance, wherein said polymer excipient acts to uniformly distribute the microspheres or microparticles administered to the suprachoroidal space.   
     
     
         10 . A method for administering drugs to an eye comprising:
 injection of a drug formulation into the suprachoroidal space, said drug formulation comprising microspheres or microparticles with an outer diameter in the range of about 1 to 33 microns;   wherein said microspheres or microparticles comprise a biologically active substance,   wherein said microspheres or microparticles subsequently migrate posteriorly to treat a posterior region distant from the injection site.   
     
     
         11 . The method according to  10  wherein said drug formulation additionally comprises a polymer excipient.