The FDA is set to review Insite Incorporated's bacterial conjunctivitis treatment Azasite having accepted an application from the California-based company.
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AzaSite is designed to treat bacterial conjunctivitis by enhancing the time the antibiotic spends on the surface of the eye.
The application included 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 significant improvements in the resolution of symptoms, and bacterial eradication.
InSite Vision said they hoped to commercially launch their AzaSite product in early 2007.
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