FEB 09, 2018
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.