19 March 2018 - pSivida today announced that its new drug application for Durasert three-year treatment for posterior segment uveitis has been accepted by the U.S. 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 six months with a p value < 0.001. In addition, the safety profile in patients treated with Durasert three-year for posterior segment uveitis was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.

Read pSivida press release