AzaSiteTreatment for Bacterial Conjunctivitis
Update: AzaSite Now FDA Approved - April 27, 2007
InSite Vision Announces Submission of AzaSite NDA
ALAMEDA, Calif., June 29, 2006 - InSite Vision Incorporated -- an ophthalmic products company currently developing therapies that treat ocular infection, glaucoma, and retinal diseases, today announced it has submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for AzaSite for the treatment of bacterial conjunctivitis. AzaSite combines a topical 1% azithromycin formulation with InSite's patented DuraSite(R) ophthalmic drug-delivery system that increases ocular retention of the drug.
InSite Vision has completed the compilation and assembly of a hybrid electronic NDA filing in a modified Common Technical Document (CTD) format. This submission incorporates the positive results from the recently completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing and controls. InSite previously announced the completion of these two Phase 3 studies including a vehicle controlled study versus AzaSite and a study comparing 0.3% tobramycin versus AzaSite. The results of these trials showed that AzaSite was safe, well tolerated and efficacious in the treatment of bacterial conjunctivitis.
Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "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."
Dr. Chandrasekaran added: "The fundamental characteristics of the AzaSite franchise remain strong and are enhanced by our significant progression announced today in our pursuit to reach commercialization for the product. Furthermore, our corporate partnership discussions are continuing as previously indicated. Our efforts in this matter are designed to ensure that we provide our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value. Details of the finalized corporate relationships will be provided when available."
Source: InSite Vision Incorporated
Posted: June 2006
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- InSite Vision Meets With the FDA on Pre-NDA Discussions - April 27, 2006