FDA Accepts Durasert NDA for 3-Year Treatment of Posterior Segment Uveitis
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Durasert 3-year treatment (pSivida Corp.) for posterior segment uveitis.
Durasert is a micro-insert implant administered as a single intravitreal injection which can be given in an office-based setting. The implant is 3.5mm in length and 0.37mm in diameter. The small molecules that make up the treatment can last for up to 3 years.
The NDA includes data from two Phase 3 studies that met the primary efficacy endpoint of prevention of recurrence of uveitis at 6 months of follow-up (P<0.001). In 1 study (n=153), 21.8% of Durasert-treated patients had a recurrence vs. 53.8% in the sham group. In addition, 12-month follow-up data in another study showed a significant reduction in recurrence with Durasert vs. sham (27.6% vs 85.7%).
The safety profile was consistent with the safety profile of steroid treatments that are currently considered standard of care for posterior segment uveitis.
Posterior segment uveitis is a chronic, non-infectious inflammatory disease and can lead to severe vision loss and blindness. "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," said Nancy Lurker, President and CEO of pSivida.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018 for Durasert.
For more information visit pSivida.com.