www.fdanews.com/articles/85254-insite-vision-announces-azasite-trial-data
INSITE VISION ANNOUNCES AZASITE TRIAL DATA
March 14, 2006
InSite Vision has announced top-line results from the second of two required Phase III clinical trials to evaluate the safety and efficacy of AzaSite (1.0 percent azithromycin solution in DuraSite) anti-infective eye drops in patients with bacterial conjunctivitis.
In a study to show superiority of AzaSite relative to vehicle, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point and a significantly higher bacterial eradication rate, a secondary end point, than those receiving placebo. Importantly, the study also showed that AzaSite was safe and well-tolerated.