Eye drop formulation

Abstract

An ophthalmic composition for administration to an eye containing 0.001-1000 micrograms per ml by weight of thymosin beta 4 (Tβ4), or an N-terminal variant, a C-Terminal variant, a conservative variant or an isoform thereof, and one or more of a tonicity agent, a buffering agent, a pH adjusting agent, and a solvent, a method of treating an eye of a human for dry eye syndrome by administering an effective amount of the ophthalmic composition to the eye of the human to treat the dry eye syndrome, and a method of treating a cornea of an eye of a human for corneal epithelial thinning by administering an effective amount of the ophthalmic composition to the cornea to treat corneal epithelial thinning.

1 . An ophthalmic composition for administration to an eye, said ophthalmic composition comprising 0.001-1000 micrograms per ml by weight of thymosin beta 4 (Tβ4), or an N-terminal variant, a C-Terminal variant, a conservative variant or an isoform thereof, and one or more of a tonicity agent, a buffering agent, a pH adjusting agent, and a solvent. 
     
     
         2 . The ophthalmic composition of  claim 1 , wherein said ophthalmic composition does not contain a preservative. 
     
     
         3 . The ophthalmic composition of  claim 1 , wherein said ophthalmic composition is sterile. 
     
     
         4 . The ophthalmic composition of  claim 1 , wherein said ophthalmic composition has a pH of 6.8 to 8.1. 
     
     
         5 . The ophthalmic composition of  claim 1 , wherein said ophthalmic composition has a pH of 5.5 to 7.8. 
     
     
         6 . The ophthalmic composition of  claim 1 , wherein said ophthalmic composition has an osmolality of approximately 150 to 450 mOsmol. 
     
     
         7 . The ophthalmic composition of  claim 1 , wherein the ophthalmic composition contains a tonicity enhancing agent selected from a group of tonicity enhancing agents consisting of ionic and non-ionic tonicity enhancing agents. 
     
     
         8 . The ophthalmic composition of  claim 7 , wherein the ionic tonicity enhancing agent is selected from a group of ionic tonicity enhancing agents consisting of alkali metal and alkaline earth metal halides. 
     
     
         9 . The ophthalmic composition of  claim 8 , wherein the ionic tonicity enhancing agent is calcium chloride (CaCl 2 ), potassium bromide (KBr), potassium chloride (KCl), Lithium Chloride (LiCl), sodium bromide (NaBr), sodium chloride (NaCl) or boric acid. 
     
     
         10 . The ophthalmic composition of  claim 7 , wherein the non-ionic tonicity enhancing agent is urea, glycerol, sorbitol, mannitol, propylene glycol, or dextrose. 
     
     
         11 . The ophthalmic composition of  claim 1 , wherein the ophthalmic composition contains a buffering substance selected from the group consisting of sodium acetate, sodium ascorbate, sodium borate, sodium carbonate, sodium citrate, sodium gluconate, sodium lactate, sodium phosphate, sodium propionate, calcium carbonate, calcium propionate, potassium phosphate and TRIS (tromethamine). 
     
     
         12 . The ophthalmic composition of  claim 1 , wherein the ophthalmic composition contains a pH adjustment agent selected from the group consisting of sodium hydroxide, hydrochloric acid and mixtures thereof. 
     
     
         13 . A method of treating an eye of a human for dry eye syndrome, said method comprising administering the ophthalmic composition of  claim 1  in an amount effective to the eye of the human to treat the dry eye syndrome. 
     
     
         14 . A method of treating a cornea of an eye of a human for corneal epithelial thinning, said method comprising administering the ophthalmic composition of  claim 1  in an amount effective to the cornea to treat the corneal epithelial thinning. 
     
     
         15 . An ophthalmic composition of  claim 1 , wherein said thymosin beta 4 (Tβ4), or an N-terminal variant, a C-Terminal variant, a conservative variant or an isoform thereof is lyophilized.