DexaSite dexamethasone: Phase III data
Top-line data from the double-blind, U.S. Phase III DOUBle trial in 907 patients with moderate to severe blepharitis showed that AzaSite Plus and DexaSite each missed the primary endpoint of complete resolution of all clinical signs and symptoms of blepharitis at day 15 vs. AzaSite and DuraSite vehicle, respectively. Specifically, the proportion of patients achieving a disease severity score of 0 points at day 15 was 8.4% for AzaSite Plus, 5.8% for DexaSite, 5.3% for AzaSite and 4.9% for DuraSite vehicle. InSite said that AzaSite Plus and DexaSite did significantly improve disease severity from baseline to day 15, but did not disclose details. Patients received AzaSite Plus, DexaSite, AzaSite or the DuraSite vehicle twice daily for 14 days. InSite, which has an SPA from FDA for the trial, plans to meet with the agency on Aug. 19 to discuss the full clinical and quality of life data from the trial and to determine next steps. The company also 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." ...