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InSite Posts Good Results in Phase III Trial
Posted on 2005-11-30 12:53:00
InSite Vision Incorporated today announced positive top-line results from a pivotal phase III clinical trial of AzaSite, a sterile, topical ophthalmic anti-infective solution containing 1.0% azithromycin formulated in DuraSite (the Company's patented drug delivery system). In an international, controlled clinical trial, subjects with bacterial conjunctivitis (pink-eye) were treated with either AzaSite dosed twice a day for the first 2 days, followed by once a day for the next 3 days or 0.3% tobramycin dosed four times a day for 5 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, according to statistical criteria which were previously agreed to by the FDA. The bacterial eradication rate was also equivalent for both groups.
Kumar Chandrasekaran, Ph.D., InSite Vision's CEO stated, "The results of this phase III clinical trial demonstrate that AzaSite is effective against bacterial conjunctivitis using a significantly reduced dosing frequency. The clinical resolution rate of less frequently dosed AzaSite is comparable to the best selling ophthalmic antibiotic products. The reduced dosing frequency can lead to improved compliance, greater patient convenience and better therapeutic outcomes. This result is a major milestone achievement in the preparation for the AzaSite NDA filing in 2006."
The phase III clinical trial was a double-blind, randomized, active-controlled study that enrolled patients ranging in age from 1 to 93 years with bacterial conjunctivitis. Patients with presumed bacterial conjunctivitis were enrolled on day 1 and a conjunctival culture was taken to demonstrate bacterial infection. All culture results were analyzed by a large central laboratory. The active control in the study was tobramycin, USP 0.3% ophthalmic solution, a broad-spectrum topical antibiotic. The treatment regimen lasted 5 days. The aim of the study was to show equivalent efficacy between patients dosed for 5 days with AzaSite versus tobramycin, AzaSite being less frequently dosed. There were a total of 47 clinical enrolling sites involved in the study; 41 in the United States and 6 in Latin America. A total of 746 subjects were enrolled in the study of which 316 had positive bacterial cultures. Among the culture positive subjects, 59% were pediatric and 41% were adult.
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