Ophthalmic compositions comprising latanoprost for use in the treatment of ocular diseases

Abstract

The invention provides a pharmaceutical composition for use in the prevention or therapy of glaucoma, increased intraocular pressure, ocular hypertension and/or a symptom associated therewith, wherein—the composition comprises latanoprost and a liquid vehicle comprising a semifluorinated alkane; and—the composition is administered to the eye of a subject; and—the amount of latanoprost administered in a single dose per eye is in the range of from about 0.5 to 1.4 μg.

1 . A pharmaceutical composition for use in the prevention or therapy of glaucoma, increased intraocular pressure, ocular hypertension and/or a symptom associated therewith, wherein
 the composition comprises latanoprost and a liquid vehicle comprising a semifluorinated alkane; and   the composition is administered to the eye of a subject; and   the amount of latanoprost administered in a single dose per eye is in the range of from about 0.5 to 1.4 μg.   
     
     
         2 . The composition for the use according to  claim 1 , wherein the semifluorinated alkane is selected from F6H8 and F4H5, preferably wherein the semifluorinated alkane is F6H8. 
     
     
         3 . The composition for use according to  claim 1  or  2 , wherein the composition is administered topically to the eye of a subject. 
     
     
         4 . The composition for use according to any one of the preceding claims, wherein the composition further comprises a solubilising agent. 
     
     
         5 . The composition for use according to  claim 4 , wherein solubilising agent is selected from ethanol, medium chain triglycerides (MCT) and diethylene glycol monoethyl ether (DEGEE). 
     
     
         6 . The composition for use according to  claim 4  or  5 , wherein the solubilising agent is comprised in an amount of up to 2.5% (w/w) with respect to the total weight of the liquid vehicle. 
     
     
         7 . The composition for use according to any one of  claims 4  to  6 , wherein the solubilising agent is ethanol. 
     
     
         8 . The composition for use according to any one of the preceding claims, wherein the composition is substantially free of water and of a preservative. 
     
     
         9 . The composition for use according to any one of the preceding claims, wherein the composition target dose volume per eye is from about 8 to 15 μl, preferably from about 10 to 12 μl. 
     
     
         10 . The composition for use according to any one of the preceding claims, wherein the composition comprises about 0.005 to 0.015% (w/v), preferably about 0.008 to 0.012% (w/v) latanoprost. 
     
     
         11 . The composition for use according to any one of the preceding claims, wherein the amount of latanoprost administered in a single dose per eye is in the range of from about 1.0 to 1.2 μg. 
     
     
         12 . The composition for use according to any one of the preceding claims, wherein the composition comprises about 0.01% (w/v) latanoprost, and wherein the latanoprost administered in a single dose per eye is about 1.1 μg and wherein the composition target dose volume per eye is about 11 μl. 
     
     
         13 . The pharmaceutical composition for use according to any one of the preceding claims, wherein the composition comprises latanoprost dissolved in a liquid vehicle essentially consisting of at least 99% (w/w) of 1-perfluorobutyl-pentane (CF 3 (CF 2 ) 3 —(CH 2 ) 4 CH 3  (F4H5)) or 1-perfluorohexyl-octane (CF 3 (CF 2 ) 5 —(CH 2 ) 7 CH 3  (F6H8)) and up to 1% (w/w) ethanol, with respect to the total weight of the liquid vehicle. 
     
     
         14 . The composition for use according to any one of the preceding claims, wherein the composition is administered once daily. 
     
     
         15 . A kit comprising a pharmaceutical composition for use according to any one of the preceding claims, wherein the kit comprises a container for holding the pharmaceutical composition and a drop dispenser for administering the composition.