InSite Vision (ISV) Plans To Submit New Drug Application To FDA For Dexasite™ For The Treatment Of Blepharitis In Adults
7/8/2014 6:36:24 AM
ALAMEDA, Calif.--(BUSINESS WIRE)--Following a June 16, 2014 meeting with the U.S. Food and Drug Administration (FDA), InSite Vision Incorporated (OTCBB:INSV) today announced that it intends to submit a New Drug Application (NDA) for DexaSite™ (dexamethasone 0.1% in DuraSite) as a treatment for blepharitis in adults during 2015, following completion of remaining chemistry and manufacturing work. In the June 16 meeting, the FDA agreed that in light of all of the historical clinical data for dexamethasone, the results of InSite’s Phase 3 study of DexaSite could support marketing approval for DexaSite in the indication of blepharitis. In its landmark Phase 3 DOUBle study, DexaSite achieved superiority versus vehicle (p-value = 0.0053) at day 15 (following 14 days of twice-daily dosing) in the clinical symptom of irritation, which was singularly judged and reported by the patient. Another independent instrument employed in this study, the Health Related Quality of Life Questionnaire, which is a patient reported outcome instrument, also supported the irritation results outcome. InSite believes this is the first time a significant improvement in a blepharitis clinical symptom has been achieved in a Phase 3 setting.
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