FDA News

InSite Vision Announces FDA Approval for AzaSite Approval Triggers $19 Million Milestone Payment

(April 30, 2007)-- InSite Vision  - an ophthalmic therapeutics, diagnostics and drug delivery company,  announced that the U.S. Food & Drug Administration (FDA) has approved InSite's New Drug Application (NDA) for AzaSite (azithromycin 1% ophthalmic solution) 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 eye.

AzaSite was shown to be safe and effective in two phase 3 clinical trials conducted in more than 1400 patients in the U.S. and Latin America. In these clinical studies which were designed and conducted in concert with Mark Abelson, M.D. and Ophthalmic Research Associates, AzaSite was administered twice daily on the first two days, then once daily on days 3-5. The results demonstrated that AzaSite 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 for 5 days. The principal investigators, Doctors Warren Heller and Eugene Protzko, respectively, formally presented these study results at the 2006 American Academy of Ophthalmology Annual Meeting and at the Association for Research in Vision and Ophthalmology Annual Meeting.

"We are truly delighted with the AzaSite product approval," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer. "This approval and our related commercialization agreement with Inspire Pharmaceuticals for the U.S. and Canada represent major accomplishments for our company and will now automatically trigger the milestone payment of $19 million. Our objective is to provide both the patient and the physician with a convenient and highly effective alternative for the treatment of bacterial conjunctivitis. We expect Inspire Pharmaceuticals to utilize an expanded sales force to launch AzaSite later this year."

Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, "We congratulate InSite Vision on the achievement of this important milestone in the development of AzaSite. We are dedicating significant resources to making AzaSite available to patients as soon as possible."

Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, at the Bascom Palmer Eye Institute of the University of Miami, commented, "AzaSite is a significant new ophthalmic product for the treatment of bacterial conjunctivitis. This unique formulation of the well-known, broad-spectrum antibiotic, azithromycin, results in a more convenient topical dosing regimen, requiring less than half the number of drops for effective treatment compared to currently available products. These attributes are particularly important when treating young children and busy adults."

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