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AzaSite

Generic name: azithromycin
Treatment for: Conjunctivitis, Bacterial

Update: AzaSite Now FDA Approved - April 27, 2007

InSite Vision Announces FDA Acceptance of New Drug Application for Review

ALAMEDA, Calif., August 28, 2006 - InSite Vision Incorporated -- an ophthalmic therapeutics, diagnostics and drug delivery company, today announced the U.S. Food and Drug Administration has accepted for filing and comprehensive review, InSite Vision's NDA for AzaSite (azithromycin 1% ophthalmic solution), indicated for the treatment of bacterial conjunctivitis. AzaSite is formulated with "DuraSite," InSite Vision's patented drug delivery vehicle which enhances the retention time of the antibiotic on the surface of the target tissue.

The NDA contains data from two phase 3 clinical trials in which 698 patients were treated with AzaSite. Data from these studies demonstrated that when AzaSite was administered twice daily on the first two days, then once daily on days 3-5, it provided clinically and statistically significant improvements in clinical resolution of symptoms, and bacterial eradication compared to placebo, and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day.

S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "Today's announcement of the FDA acceptance and review of InSite Vision's NDA is a significant milestone which brings us one step closer to achieving our ultimate goal of the commercialization of our lead AzaSite product in early 2007. We expect a timely review by the FDA and look forward to hearing from them regarding next steps."

Source: InSite Vision Incorporated

Posted: August 2006

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