InSite Vision (ISV) Announces Positive Meeting With Swedish Medical Products Agency Regarding Filing For Marketing Approval Of BromSite®
5/29/2014 9:10:45 AM
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today announced that the Swedish Medical Products Agency (MPA) concluded that the existing Phase 3 clinical data for BromSite™ for the prevention of pain and inflammation in ocular surgery was likely sufficient to support the filing of a Marketing Authorization Application (MAA) with the MPA. Prior to the meeting with the MPA on May 26, 2014, InSite Vision had submitted substantial preliminary BromSite information to the Agency including CMC (chemistry, manufacturing, and controls) data, preclinical and clinical data sets and analytical methods.
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