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    • 09 FEB 18
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    Durasert offers lasting protection against uveitis flares

    Durasert offers lasting protection against uveitis flares

    FEB 09, 2018

    By Keng Jin Lee

    Nasdaq

    Uveitis

    pSivida’s injectable fluocinolone acetonide implant was effective at preventing recurrence of posterior uveitis for at least 1 year, according to interim findings from a second phase 3 trial.

    “The continued positive efficacy and safety data for Durasert, now confirmed in two separate phase 3 studies at both 6 and 12 months, is encouraging for patients that are suffering from posterior segment uveitis,” said primary clinical investigator Glenn J. Jaffe, MD, of Duke University.

    Durasert is a preventative measure, while most standard-of-care treatments are effective only during flareups. The implant can be inserted during an office-based procedure and is designed to remain in place for 3 years, Dr. Jaffe noted in this interview from AAO 2017.

    The randomized trial enrolled 153 patients with posterior segment uveitis. Durasert met its primary efficacy endpoint by 6 months, showing a significantly lower rate of uveitis recurrence compared with sham.

    By 12 months, the treatment group showed significantly less recurrence than the sham group (36.6% vs. 71.2%, P<0.001).  Mean IOP increased by 2 mm Hg and 0 mm Hg in the Durasert and sham groups, respectively. Only 1 Durasert patient required IOP surgery during the 12 months of follow-up.

    The trial is ongoing and will follow patients for 3 years. In the meantime, pSivida submitted a New Drug Application to the FDA for Durasert in January 2018.

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