pSivida announced that its new drug application (NDA) for its Durasert 3-year treatment for posterior segment uveitis has been accepted by the FDA for filing. The acceptance of the NDA reflects the FDA’s determination that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
The NDA includes data from two phase 3 studies that each successfully achieved the primary efficacy endpoint at 6 months with a P value < 0.001. In addition, the safety profile in patients treated with Durasert 3-year for posterior segment uveitis was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.
"The FDA’s acceptance for review of our Durasert NDA submission is a major milestone for pSivida and we look forward to continuing to work with the FDA as they review our application," Nancy Lurker, President and CEO, said in a company news release. "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.”