BioCentury
ARTICLE | Clinical News

InSite reports Phase III blepharitis data

July 24, 2013 12:52 AM UTC

InSite Vision Inc. (OTCBB:INSV) said twice-daily AzaSite Plus and DexaSite dexamethasone for 14 days each missed the primary endpoint of complete resolution of all clinical signs and symptoms of blepharitis at day 15 vs. AzaSite and vehicle, respectively, in the 907-patient Phase III DOUBle trial to treat blepharitis. InSite said AzaSite Plus ( ISV-502) and DexaSite ( ISV-305) did significantly improve disease severity from baseline to day 15, but did not disclose details. InSite, which has an SPA from FDA for the trial, is meeting with the agency in August to discuss the data and to determine next steps. The company said the data support the "emerging clinical viewpoint that blepharitis is a chronic and incurable disease which may require a different clinical approach versus a therapeutic approach for an acute disease."

DexaSite is dexamethasone in InSite's DuraSite ophthalmic drug delivery system. The product also has completed a Phase III trial to treat ocular inflammation. AzaSite Plus is a fixed-dose combination of azithromycin, an antibiotic, and dexamethasone formulated with DuraSite. The product has completed a Phase III trial to treat blepharoconjunctivitis. Merck & Co. Inc. (NYSE:MRK) markets AzaSite -- 1% azithromycin in DuraSite -- in the U.S. and Canada to treat bacterial conjunctivitis. ...