HyperOsmolar Composition of Hyaluronic Acid

Abstract

The invention relates to a novel hyperosmolar composition of hyaluronic acid for the use thereof in the treatment of corneal oedema.

1 . Hyperosmolar ophthalmic composition comprising hyaluronic acid or an acceptable salt thereof, wherein it comprises a hyperosmolarity agent and it has an osmolarity of 650 to 2000 mOsm/l. 
     
     
         2 . Composition according to  claim 1 , wherein the osmolarity agent is selected from the group consisting of sodium chloride, potassium chloride, glycerol and mixtures thereof. 
     
     
         3 . Composition according to  claim 2  wherein said osmolarity agent is sodium chloride and amounts to 4 to 6% by weight of the composition. 
     
     
         4 . Composition according to  claim 1  wherein the hyaluronic acid has an intrinsic viscosity of 1.4 to 1.9 m 3 /kg. 
     
     
         5 . Composition according to  claim 1  wherein the hyaluronic acid is present in the form of sodium hyaluronate. 
     
     
         6 . Composition according to  claim 5 , wherein it comprises 0.01 to 0.25% by weight of sodium hyaluronate. 
     
     
         7 . Composition according to  claim 1  wherein it has a viscosity of 15 to 100 centipoises. 
     
     
         8 . Composition according to  claim 1  wherein it comprises a viscosity agent selected from the group consisting of hydroxypropylmethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, carbomers, agar gels, polyvinylpyrrolidone and polyvinyl alcohol. 
     
     
         9 . Composition according to  claim 1  wherein it comprises 0.05 to 0.5% by weight of hydroxypropylmethyl cellulose. 
     
     
         10 .- 16 . (canceled) 
     
     
         17 . Method for treating corneal oedema in a subject in need thereof, said method comprising applying in the eye of said subject one or more drops of an ophtalmic composition comprising hyaluronic acid or an acceptable salt thereof, wherein said composition comprises a hyperosmolarity agent and has an osmolarity of 650 to 2000 mOsm/l. 
     
     
         18 . Method according to  claim 17 , wherein the corneal oedema is a chronic corneal oedema (CCE). 
     
     
         19 . Method according to  claim 17 , wherein the treatment comprises a first application in the eye of the subject of a suitable dose of the composition followed by a second application of a suitable dose 30 minutes to 90 minutes after the first application. 
     
     
         20 . Method according to  claim 19 , wherein it comprises a third application of a suitable dose 30 minutes to 90 minutes after the second application. 
     
     
         21 . Method according to  claim 17 , wherein the treatment comprises the application in the eye of the subject of a suitable dose of the composition repeated at least 3 times per day, with an interval between the applications of 30 minutes to 90 minutes. 
     
     
         22 . Method according to  claim 21 , wherein the first application is given when the patient awakens in the morning or shortly thereafter. 
     
     
         23 . Method according to  claim 17 , wherein the treatment is given for a period of at least 2 weeks, ranging up to at least 4 weeks. 
     
     
         24 . Method according to  claim 17 , wherein in said composition the osmolarity agent is selected from the group consisting of sodium chloride, potassium chloride, glycerol and mixtures thereof. 
     
     
         25 . Method according to  claim 17 , wherein said osmolarity agent is sodium chloride in an amount of from 4 to 6% by weight of the composition. 
     
     
         26 . Method according to  claim 17  wherein in said composition the hyaluronic acid has an intrinsic viscosity of 1.4 to 1.9 m 3 /kg. 
     
     
         27 . Method according to  claim 17  wherein in said composition the hyaluronic acid is present in the form of sodium hyaluronate. 
     
     
         28 . Method according to  claim 17 , wherein the composition comprises 0.01 to 0.25% by weight of sodium hyaluronate. 
     
     
         29 . Method according to  claim 17  wherein said composition has a viscosity of 15 to 100 centipoises. 
     
     
         30 . Method according to  claim 17  wherein said composition comprises a viscosity agent selected from the group consisting of hydroxypropylmethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, carbomers, agar gels, polyvinylpyrrolidone and polyvinyl alcohol. 
     
     
         31 . Method according to  claim 17  wherein said composition comprises 0.05 to 0.5% by weight of hydroxypropylmethyl cellulose.