pSivida Offers Added Favorable Six-Month Safety Results for Medidur for PU

pSivida Corp.

a leader in the development of sustained release drug delivery products for treating eye diseases, today reported favorable results from additional analysis of the six-month safety data from pSivida's first Phase 3 pivotal clinical trial for Medidur for posterior uveitis. There was a small average increase in intraocular pressure (IOP) in Medidur-treated eyes through six months relative to control. Medidur eyes increased on average only 1.1mmHg more than control eyes (1.8mmHg increase compared to 0.7mmHg). The percentage of eyes requiring treatment with eye drops for IOP was comparable between Medidur and control eyes. Only 1% more Medidur-treated eyes than control eyes received treatment with eye drops for elevated IOP (19% compared to 18%) through six months. "We are very pleased with this new safety data through six months showing a small average increase in IOP for Medidur treatment relative to control and comparable incidence of treatment with eye drops for IOP in both groups. The average increase in IOP for Medidur-treated eyes was lower than that observed in the same period in the clinical trials for Ozurdex® and Retisert®, the two FDA-approved sustained release treatments for posterior uveitis," said Dr. Paul Ashton, president and CEO of pSivida. "Our first trial also showed Medidur to be highly effective. We earlier reported that this trial achieved its primary end point – prevention of recurrence of disease at six months -- with high statistical significance (p less than 0.0000001, intent to treat analysis)." pSivida plans to meet with the FDA next quarter to discuss the first Phase 3 trial results and to confirm that data from two trials will continue to be required for a U.S. New Drug Application (NDA) currently planned for the first half of calendar 2017. As a result of the high statistical significance achieved in the first Phase 3 trial, pSivida plans to file for European Union (EU) marketing approval based on data from the single trial in late 2016.