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  • Patent issued for bromfenac formulations

    InSiteVision Incorporated
    Cataract/Anterior Segment, Comprehensive Ophthalmology, Cornea/External Disease, Retina/Vitreous
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    InSite Vision announced that it has received broad U.S. patent protection covering bromfenac non-steroidal ophthalmic compositions formulated in its DuraSite drug delivery systems designed to extend the duration of drug retention.

    The patent will provide protection to the following products until August 2029:

    • BromSite (bromfenac 0.075% ophthalmic solution formulated in DuraSite) for the treatment of inflammation and prevention of pain post cataract surgery;
    • ISV-101 (bromfenac 0.01%-0.04% ophthalmic solution formulated in DuraSite) for dry eye disease;
    • Back-of-the eye BromSite indications, such as the prevention of cystoid macular edema; and
    • Products containing a combination of bromfenac and dexamethasone, such as BromDex.

    The DuraSite platform is currently used in two commercial products for the treatment of bacterial eye infections: AzaSite (azithromycin ophthalmic solution) 1%, marketed in the United States by Akorn Inc.; and Besivance(besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb.

    InSite has successfully completed two phase 3 clinical trials of BromSite and plans to file a New Drug Application (NDA) with the U.S. FDA in the second half of 2014, after which it plans to pursue European regulatory approvals of BromSite.

    InSite is also advancing AzaSite Plus through phase 3 clinical studies for the treatment of eye infections, and is preparing an NDA for DexaSite for blepharitis.