Posted by Michael Wonder on 23 Jun 2017
pSivida submits marketing authorisation application for approval of Durasert three year treatment for posterior segment uveitis in the European Union
22 June 2017 - pSivida has submitted a Marketing Authorization Application to the EMA, seeking approval to market the Company's Durasert three-year treatment for posterior segment uveitis in the European Union.
In each of pSivida's two Phase 3 trials for its Durasert three-year uveitis treatment, the primary efficacy endpoint was successfully achieved at six months with a p value < 0.001. In addition, the safety profile of patients treated with Durasert three-year uveitis treatment was comparable to the safety profile of existing steroid uveitis treatments, which are considered standard of care for this disease.
