Methods and devices for the treatment of ocular diseases in human subjects

Abstract

Methods and devices are provided for targeted non-surgical administration of a drug formulation to the suprachoroidal space (SCS) of the eye of a human subject for the treatment of a posterior ocular disorder or a choroidal malady. In one embodiment, the method comprises inserting a hollow microneedle into the eye at an insertion site and infusing a drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. In one embodiment, the fluid drug formulation comprises drug nanoparticles or microparticles.

What is claimed is: 
     
         1 . A composition comprising triamcinolone actinide (TA), wherein the composition is a suspension comprising TA in particles having a D 50  of about 2 μm or less, wherein the composition further comprises a surfactant, and wherein the composition is suitable for injection into the suprachoroidal space of an eye. 
     
     
         2 . The composition of  claim 1 , further comprising carboxymethylcellulose sodium. 
     
     
         3 . The composition of  claim 2 , wherein the carboxymethylcellulose sodium is at a w/v % of about 0.5%. 
     
     
         4 . The composition of  claim 1 , wherein the TA is present in the composition from about 1 mg/mL to about 400 mg/mL. 
     
     
         5 . The composition of  claim 4 , wherein the TA is present in the composition from about 10 mg/mL to about 100 mg/mL. 
     
     
         6 . The composition of  claim 1 , wherein the TA is present in the composition at about 40 mg/mL. 
     
     
         7 . The composition of  claim 1 , wherein the surfactant is polysorbate 80. 
     
     
         8 . The composition of  claim 7 , wherein the surfactant is polysorbate 80 at a w/v % of about 0.015% to about 0.02%. 
     
     
         9 . The composition of  claim 8 , wherein the polysorbate 80 is at a w/v % of about 0.02%. 
     
     
         10 . The composition of  claim 1 , further comprising sodium chloride. 
     
     
         11 . The composition of  claim 1 , further comprising sodium acetate. 
     
     
         12 . The composition of  claim 11 , wherein the sodium acetate is at a w/v % of about 0.39/%. 
     
     
         13 . The composition of  claim 1 , wherein the particles have a D 99  of 10 μm or less. 
     
     
         14 . The composition of  claim 1 , wherein the pH of the composition is between about 6.0 and about 7.5. 
     
     
         15 . The composition of  claim 1 , comprising about 40 mg/mL TA, about 0.02% polysorbate 80, and about 0.5% w/v carboxymethylcellulose. 
     
     
         16 . The composition of  claim 15 , further comprising NaCl, KCl, CaCl 2 ), MgCl 2 , sodium acetate, sodium citrate, and water.