Methods for treating ocular inflammatory diseases

Abstract

A method of treating non-infectious, inflammatory blepharitis includes administering to the affected eye of a subject an effective amount of an active ingredient in an ophthalmically acceptable vehicle for a sufficient period of time to treat the non-infectious, inflammatory blepharitis. The active ingredient consists essentially of a glucocorticoid in an ophthalmically acceptable vehicle that includes an aqueous polymer suspension that when mixed with tear fluid provides a sustained release of said active ingredient. The aqueous polymer suspension includes a carboxyl-containing polymer having less than about 5% by weight cross-linking agent and has a viscosity in a range from about 1,000 to about 30,000 centipoises. A kit includes: (a) a composition comprising about 0.1% by weight dexamethasone in this ophthalmically acceptable vehicle and (b) instructions for using the composition of (a) for the treatment of blepharitis.

What is claimed is: 
     
         1 . A kit comprising: (a) a topical pharmaceutical formulation for administering to an eye of a subject, the composition comprising an effective amount of a glucocorticoid in an ophthalmically acceptable vehicle comprising an aqueous polymer suspension, wherein said aqueous polymer suspension comprises a carboxyl-containing polymer having less than about 5% by weight cross-linking agent and has a viscosity in a range from about 1,000 to about 30,000 centipoises, and (b) instructions for using the composition of (a) for the treatment of non-infectious, inflammatory blepharitis. 
     
     
         2 . The kit of  claim 1 , wherein the glucocorticoid is selected from the group consisting of hydrocortisone, cortisone acetate, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, and beclometasone, fluorometholone. 
     
     
         3 . The kit of  claim 2 , wherein the glucocorticoid is dexamethasone. 
     
     
         4 . The kit of  claim 1 , wherein the glucocorticoid is present in a range from about 0.05% and to about 0.5% by weight. 
     
     
         5 . The kit of  claim 4 , wherein the glucocorticoid is present in a range from about 0.08% to about 0.12% by weight. 
     
     
         6 . The kit of  claim 3 , wherein the glucocorticoid is present in at about 0.1% by weight. 
     
     
         7 . The kit of  claim 1 , wherein said ophthalmically acceptable vehicle further comprises a preservative. 
     
     
         8 . The kit of  claim 1 , wherein said preservative comprises benzalkonium chloride. 
     
     
         9 . The kit of  claim 8 , wherein said preservative is present in a range from about 0.001 to about 0.005% by weight. 
     
     
         10 . The kit of  claim 1 , wherein the average particle size of the carboxyl-containing-polymer particles is in the range of 6 μm to 50 μm. 
     
     
         11 . The kit of  claim 1 , wherein the carboxyl-containing-polymer is present from about 0. 1% to about 6.5% by weight, based on the total weight of the suspension. 
     
     
         12 . The kit of  claim 1 , wherein the pharmaceutical formulation further comprises a second polymer as a viscosifier. 
     
     
         13 . The kit of  claim 12 , wherein the second polymer is chitosan or a chitosan salt in an amount from about 0.01% to 0.5% by weight. 
     
     
         14 . The kit of  claim 13 , wherein chitosan or chitosan salt has a molecular weight in a range from between about 50 kDa to about 100 kDa. 
     
     
         15 . The kit of  claim 13 , wherein chitosan or chitosan salt has a molecular weight in a range from between about 1000 kDa to about 3000 kDa. 
     
     
         16 . The kit according to  claim 1 , where the origin of blepharitis is not related to bacteria.