Treatment of ocular inflammatory diseases using laquinimod

Abstract

Disclosed is a method for treating an ocular inflammatory disease (OID), e.g., uveitis or conjunctivitis, comprising periodic administration of a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt thereof. Also provided is a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof for use in treating a subject suffering from an OID, uveitis, bacterial conjunctivitis, viral conjunctivitis, an inflammation of the orbital tissue, the lacrimal apparatus, the eyelid, the cornea, the retina or the optic pathway. This application also provides a method for treating a subject suffering from an autoimmune disease-associated ocular inflammation comprising periodic ocular administration to the subject a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt, and an ocular pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof for use in treating an autoimmune disease-associated ocular inflammation.

1 . A method of treating a subject suffering from an ocular inflammatory disease, the method comprising periodic administration to the subject of a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt thereof effective to treat the subject. 
     
     
         2 . The method of  claim 1 , wherein the therapeutically effective amount of laquinimod is effective to reduce a symptom of the ocular inflammatory disease in the subject, induce clinical response, induce or maintain clinical remission, inhibit disease progression, inhibit a disease complication, reduce intraocular inflammation or reduce retina tissue destruction in the subject. 
     
     
         3 . The method of  claim 1 , wherein the ocular inflammatory disease is uveitis, bacterial conjunctivitis, viral conjunctivitis, or an inflammation of the orbital tissue, the lacrimal apparatus, the eyelid, the cornea, the retina or the optic pathway. 
     
     
         4 . The method of  claim 3 , wherein the ocular inflammatory disease is conjunctivitis and the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to reduce a symptom of conjunctivitis in the subject or wherein the ocular inflammatory disease is uveitis and the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to reduce a symptom of uveitis in the subject. 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 4 , wherein the uveitis is anterior uveitis, intermediate uveitis, posterior uveitis, or diffuse uveitis. 
     
     
         7 . The method of  claim 3 , wherein the ocular inflammatory disease is an inflammation of the orbital tissue, the lacrimal apparatus, the eyelid, the cornea, the retina or the optic pathway and the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to reduce a symptom of the inflammation in the subject. 
     
     
         8 . The method of  claim 1 , wherein the laquinimod or pharmaceutically acceptable salt thereof is administered in the form of a liquid or a gel. 
     
     
         9 . The method of  claim 8 , wherein the concentration of laquinimod or pharmaceutically acceptable salt thereof in the liquid or gel 5-100 mg/ml solution or 10-15 mg/ml solution. 
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is 0.05-4.0 mg per administration, 0.05-2.0 mg per administration, about 0.1 mg per administration or about 0.5 mg per administration. 
     
     
         12 - 14 . (canceled) 
     
     
         15 . The method of  claim 1 , wherein the ocular inflammatory disease is allergic conjunctivitis or uveitis and wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is at least 0.2 mg/day. 
     
     
         16 . The method of  claim 15 , wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to reduce a symptom of the allergic conjunctivitis or uveitis in the subject. 
     
     
         17 . The method of  claim 15 , wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to inhibit late ocular anaphylaxis in the subject 
     
     
         18 . The method of  claim 15 , wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is effective to reduce eosinophil infiltration into the conjunctiva of the subject. 
     
     
         19 - 21 . (canceled) 
     
     
         22 . The method of  claim 15 , wherein the laquinimod or pharmaceutically acceptable salt thereof is administered in the form of a liquid or a gel. 
     
     
         23 . The method of  claim 22 , wherein the concentration of laquinimod or pharmaceutically acceptable salt thereof in the liquid or gel is 20-100 mg/ml solution or 20-50 mg/ml solution. 
     
     
         24 . (canceled) 
     
     
         25 . The method of  claim 15 , wherein the therapeutically effective amount of laquinimod or pharmaceutically acceptable salt thereof is 0.2-4.0 mg per administration, 0.2-2.0 mg per administration or about 0.5 mg per administration. 
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 1 , wherein the periodic administration is once per day. 
     
     
         29 . The method of  claim 1 , wherein the periodic administration is oral administration and/or ocular administration. 
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of laquinimod is laquinimod sodium or wherein the subject is a human. 
     
     
         32 - 35 . (canceled) 
     
     
         36 . A method of treating a subject suffering from an autoimmune disease-associated ocular inflammation, the method comprising periodic ocular administration to the subject of a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt thereof effective to treat the subject. 
     
     
         37 . (canceled)