Press Release

Vision Submits NDA For AzaSite In The Treatment Of Bacterial Conjunctivitis With U.S. FDA - Update
Thursday, June 29, 2006; Posted: 12:40 PM

RTTNews) - Thursday, InSite Vision, Inc. (ISV | charts | news | PowerRating), an ophthalmic products company, revealed the submission of a New Drug Application or NDA with the U.S. Food and Drug Administration for AzaSite indicated in the treatment of bacterial conjunctivitis. The submission includes positive results from the completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing, and controls.


The Alameda, California-based company had previously confirmed the completion of two Phase 3 studies inclusive of the vehicle controlled study with AzaSite and the comparison of 0.3% tobramycin and AzaSite. The studies had indicated AzaSite to be safe, well tolerated, and efficacious in the treatment of conjunctivitis. AzaSite is a combination of topical 1% azithromycin formulation with InSite's patented DuraSite ophthalmic drug-delivery system that increases ocular retention of the drug.

Dr. Kumar Chandrasekaran, Chief Executive Officer, InSite Vision, said, "The submission of the AzaSite NDA is a major milestone for InSite Vision and brings our lead product one very significant step further in the FDA approval process. We anticipate the launch of AzaSite in early 2007 as we pursue development of additional products that make up the AzaSite franchise."

ISV is gaining $0.07 or 4.58% and currently trades at $1.60, on a volume of 337,500 shares on the AMEX. Copyright(c) 2006