Posted by Michael Wonder on 09 Jan 2018
pSivida submits new drug application for Durasert three year treatment for posterior segment uveitis to the U.S. FDA
8 January 2018 - Proven Durasert technology has to date received FDA approval for three of the four sustained release drug products approved for back-of-the-eye diseases.
pSivida today announced it has submitted its new drug application to the U.S. Food and Drug Administration for Durasert three-year treatment for posterior segment uveitis.
The application 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 of patients treated with Durasert three-year posterior segment uveitis treatment was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.
