Compositions & methods for lowering intraocular pressure

Abstract

Disclosed herein are compositions for lowering intraocular pressure (IOP) of an eye comprising a combination IOP-lowering agents bimatoprost, brimonidine, and timolol. Further disclosed are methods for reducing IOP in the eye of a subject.

What is claimed is: 
     
         1 ) A pharmaceutical composition for lowering intraocular pressure in a patient suffering from elevated intraocular pressure comprising bimatoprost, brimonidine, and timolol. 
     
     
         2 ) The pharmaceutical composition of  claim 1  wherein the pharmaceutical composition is effective in lowering intraocular pressure in patients who do not have adequate IOP control with mono or dual combination therapy. 
     
     
         3 ) The pharmaceutical composition of  claim 1  wherein the brimonidine is brimonidine tartrate and the timolol is timolol maleate. 
     
     
         4 ) The pharmaceutical composition of  claim 2  wherein the composition is applied topically and further comprising sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, and sodium hydroxide in an aqueous carrier. 
     
     
         5 ) The pharmaceutical composition of  claim 3  further comprising benzalkonium chloride. 
     
     
         6 ) The pharmaceutical composition of  claim 1  comprising about 0.01% w/v bimatoprost, about 0.15% w/v brimonidine tartrate and about 0.68% w/v timolol maleate. 
     
     
         7 ) The pharmaceutical composition of  claim 5  further comprising about 0.005% w/v benzalkonium chloride. 
     
     
         8 ) A pharmaceutical composition for lowering IOP in patients suffering from elevated IOP who do not have adequate IOP control with mono or dual combination therapy consisting essentially of bimatoprost, brimonidine tartrate, timolol maleate, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, and sodium hydroxide in an aqueous carrier. 
     
     
         9 ) The pharmaceutical composition of  claim 8  further consisting essentially of benzalkonium chloride. 
     
     
         10 ) The pharmaceutical composition of  claim 8  consisting essentially of about 0.01% w/v bimatoprost, about 0.15% w/v brimonidine tartrate, about 0.68% w/v timolol maleate, about 1.5% w/v sodium phosphate dibasic heptahydrate, about 0.025% w/v citric acid monohydrate and about 0.35% w/v sodium chloride. 
     
     
         11 ) The pharmaceutical composition of  claim 10  consisting essentially of about 0.005% w/v benzalkonium chloride. 
     
     
         12 ) The pharmaceutical composition of  claim 8  wherein said composition consists of bimatoprost, brimonidine tartrate, timolol maleate, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, and sodium hydroxide in an aqueous carrier. 
     
     
         13 ) The pharmaceutical composition of  claim 12  further consisting of benzalkonium chloride. 
     
     
         14 ) A method of reducing intraocular pressure (IOP) in a patient suffering from elevated IOP in patients who do not have adequate IOP control with mono or dual combination therapy comprising administering a topical pharmaceutical composition comprising bimatoprost, brimonidine, and timolol to the eye of a subject in need thereof. 
     
     
         15 ) The method of  claim 14  wherein the pharmaceutical composition further comprises sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, and sodium hydroxide in an aqueous carrier. 
     
     
         16 ) The method of  claim 15  wherein the pharmaceutical composition further comprises benzalkonium chloride and is applied to the eye at least once a day. 
     
     
         17 ) The method of  claim 15  wherein said composition consists essentially of bimatoprost, brimonidine tartrate, timolol maleate, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, and sodium hydroxide in an aqueous carrier. 
     
     
         18 ) The method of  claim 16  wherein said composition is applied twice a day. 
     
     
         19 ) The method of  claim 17  wherein said composition consists essentially of 0.01% w/v bimatoprost, 0.15% w/v brimonidine tartrate, 0.68% w/v timolol maleate, 1.5% w/v sodium phosphate dibasic heptahydrate, 0.025% w/v citric acid monohydrate and 0.35% w/v sodium chloride. 
     
     
         20 ) The method of  claim 18  wherein said composition consists essentially of 0.005% w/v benzalkonium chloride.