The FDA has accepted a new drug application for Durasert 3-year treatment for posterior segment uveitis, pSivida announced in a press release.
Two phase 3 studies of Durasert met their primary efficacy endpoints of reducing the recurrence of posterior segment uveitis in patients through 6 months of treatment.
“Given the high unmet medical need, we believe that Durasert, if approved, has the potential to become an important new treatment option for the thousands of patients suffering from posterior segment uveitis, the third leading cause of blindness,” Nancy Lurker, pSivida
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