US2008207495A1PendingUtilityA1

Cyclosporin compositions for ocular rosacea treatment

59
Individually held — no corporate assignee on recordPriority: Jul 25, 2006Filed: Feb 22, 2008Published: Aug 28, 2008
Est. expiryJul 25, 2026(~0 yrs left)· nominal 20-yr term from priority
Inventors:Richard S. GrahamWalter L. TienMayssa AttarRhett M. SchiffmanMichael E. SternRobin SearsJohn G. WaltTamara Cassaro
A61P 27/02A61K 47/10A61K 47/44A61K 38/13A61P 27/04A61K 9/0048A61K 9/08A61K 47/32A61K 47/26A61K 47/02A61P 27/00
59
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Disclosed herein are methods of treating ocular rosacea with cyclosporin A. Compositions and medicaments related thereto are also disclosed.

Claims

exact text as granted — not AI-modified
1 . A method of treating ocular rosacea comprising topically administering to a mammal in need thereof a composition comprising cyclosporin A at a concentration of from about 0.0001% (w/v) to less than about 0.05% (w/v). 
     
     
         2 . The method of  claim 1  wherein the composition is an aqueous solution. 
     
     
         3 . The method of  claim 1  wherein the concentration of cyclosporin A is from about 0.005% (w/v) to about 0.04% (w/v). 
     
     
         4 . The method of  claim 2  wherein the concentration of cyclosporin A is from about 0.02% (w/v) to about 0.04% (w/v). 
     
     
         5 . The method of  claim 2  wherein the composition contains no ethanol. 
     
     
         6 . The method of  claim 2  wherein the composition contains no hyaluronic acid. 
     
     
         7 . The method of  claim 2  wherein the composition contains no cyclodextrin A. 
     
     
         8 . The method of  claim 6  wherein the composition contains no cyclodextrin. 
     
     
         9 . The method of  claim 8  wherein the composition contains no ethanol. 
     
     
         10 . The method of  claim 9  wherein the composition contains no hyaluronic acid. 
     
     
         11 . The method of  claim 2  wherein the composition is administered only once a day. 
     
     
         12 . The method of  claim 10  wherein the composition is administered only once a day. 
     
     
         13 . The method of  claim 1  wherein topical administration of one 35 μL drop of said composition to each eye of a female New Zealand white rabbit provides to the corneas of said rabbit at least about 500 ng of cyclosporin A per gram of cornea of said rabbit at 30 minutes after said topical administration. 
     
     
         14 . The method of  claim 12 , wherein the mammal is a human. 
     
     
         15 . The method of  claim 1  wherein topical administration of one 35 μL drop of said composition to each eye of a female New Zealand white rabbit provides to the corneas of said rabbit at least about 1000 ng of cyclosporin A per gram of cornea of said rabbit at 30 minutes after said topical administration. 
     
     
         16 . The method of  claim 1  wherein topical administration of one 35 μL drop of said composition to each eye of a female New Zealand white rabbit provides to the corneas of said rabbit at least about 1400 ng of cyclosporin A per gram of cornea of said rabbit at 30 minutes after said topical administration. 
     
     
         17 . The method of  claim 1  wherein topical administration of one 35 μL drop of said composition to each eye of a female New Zealand white rabbit provides to the corneas of said rabbit at least about 17000 ng·hr of cyclosporin A per gram of cornea of said rabbit over a period of 24 hours after said topical administration. 
     
     
         18 . The method of  claim 2  wherein topical administration of one 35 μL drop of said composition to each eye of a female New Zealand white rabbit provides to the conjunctivas of said rabbit at least about 3300 ng·hr of cyclosporin A per gram of conjunctiva of said rabbit over a period of 24 hours after said topical administration. 
     
     
         19 . The method of  claim 2  wherein said composition is an aqueous solution containing from 0.005% (w/v) to about 0.04% (w/v) cyclosporin A, wherein topical administration of one 35 μL drop of said composition to each eye of a New Zealand rabbit provides at least about 17000 ng·hr of cyclosporin A per gram of cornea to the corneas of said rabbit as determined by:
 topically administering said composition to each eye of each of 15 female New Zealand white rabbit test subjects; and   determining the amount of cyclosporin A in the corneas of three subjects at times of about 0.5 hours, about 2 hours, about 6 hours, about 12 hours, and about 24 after administration to said subject;   wherein the amount of cyclosporin A in the cornea is determined only once for each subject.   
     
     
         20 . The method of  claim 2  wherein said composition is an aqueous solution containing from 0.005% (w/v) to about 0.04% (w/v) cyclosporin A, wherein topical administration of one 35 μL drop of said composition to each eye of a New Zealand rabbit provides at least about 6000 ng of cyclosporin A per gram of conjunctiva to the conjunctivas of said rabbit as determined by:
 topically administering said composition to each eye of each of 15 female New Zealand white rabbit test subjects; and   determining the amount of cyclosporin A in the conjunctivas of three subjects at times of about 0.5 hours, about 2 hours, about 6 hours, about 12 hours, and about 24 after administration to said subject;   wherein the amount of cyclosporin A in the conjunctiva is determined only a single time for each subject.   
     
     
         21 . The method of  claim 1  wherein the mammal is a human patient, and wherein less than 10% of human patients suffer burning or stinging when said composition is administered only once a day for a period of three months. 
     
     
         22 . The method of  claim 1  wherein the composition contains a surfactant. 
     
     
         23 . A method of treating ocular rosacea comprising topically administering to a mammal a multi-use composition comprising cyclosporin A at a concentration of from about 0.0001% (w/v) to less than about 0.2% (w/v), and an effective amount of a preservative. 
     
     
         24 . The method of claim  61  wherein the preservative is an oxidizing preservative. 
     
     
         25 . The method of claim  61  wherein the preservative is a cationic preservative.

Join the waitlist — get patent alerts

Track US2008207495A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.