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news.InSite Vision has announced positive top-line results from a pivotal phase III clinical trial of its ophthalmic anti-infective solution AzaSite, in the treatment of patients with bacterial conjunctivitis.
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In an international, controlled clinical trial, subjects with bacterial conjunctivitis (pink-eye) were treated with either AzaSite dosed twice a day for the first two days, followed by once a day for the next three days, or 0.3% tobramycin (a rival ophthalmic antibiotic) dosed four times a day for five days.
AzaSite demonstrated a clinical resolution rate of 80% as compared to 78% for tobramycin. This result shows that the clinical resolution rate of AzaSite is equivalent to tobramycin, the primary efficacy endpoint of the study. The bacterial eradication rate was also equivalent for both groups.
“The results of this phase III clinical trial demonstrate that AzaSite is effective against bacterial conjunctivitis using a significantly reduced dosing frequency,” Dr Kumar Chandrasekaran, InSite Vision’s CEO. “The reduced dosing frequency can lead to improved compliance, greater patient convenience and better therapeutic outcomes.”