PSivida: Durasert Second Phase 3 Trial Meets Primary Efficacy Goal

(RTTNews) - pSivida Corp. (PSDV, PVA.AX), a developer of sustained release drug products and technologies, announced Tuesday that its second Phase 3 trial of Durasert three-year treatment for posterior segment uveitis achieved the trial's primary endpoint.

In pre-market activity on Nasdaq, the shares were gaining around 12 percent to $2.33.

The company said the results of the second Phase 3 study confirm the efficacy and safety profile of the Durasert three-year insert demonstrated in the first Phase 3 study.

The company continues to expect the submission of the European Market Authorization Application or MAA by the end of June, and remains on track to also file a New Drug Application with the FDA in the calendar fourth quarter of 2017.

In its statement, the company noted that the study involved 153 patients and the primary endpoint was prevention of recurrence of posterior uveitis at six months with patients continuing to be followed for 36 months.

Durasert three-year insert demonstrated a significant reduction in the recurrence of posterior segment uveitis through six months, the company said.

Nancy Lurker, President and CEO of pSivida, said, "The data from this trial confirms previous clinical research demonstrating our three-year Durasert insert for posterior segment uveitis may significantly help patients suffering from this devastating disease -- the third leading cause of blindness. Our market research indicates strong interest in using the product driven by the results of our first Phase 3 clinical trial."