BioCentury
ARTICLE | Clinical News

pSivida rises on Phase III uveitis data

December 23, 2015 1:51 AM UTC

pSivida Corp. (NASDAQ:PSDV; ASX:PVA) gained $0.79 (21%) to $4.49 on NASDAQ on Tuesday after its Medidur fluocinolone acetonide intravitreal implant met the primary endpoint in a Phase III study to treat chronic, non-infectious posterior uveitis. pSivida expects to submit an NDA to FDA for the therapy in 1H17, pending results of a second, ongoing Phase III trial.

In the 129-patient study's intent-to-treat population, pSivida said 18.4% of eyes treated with Medidur had a recurrence of posterior uveitis after six months compared with 78.6% of sham-injected eyes (p<0.00000001), meeting the primary endpoint. The company also said 23% of eyes treated with Medidur showed improvement in visual acuity, compared to 4.9% of those receiving control (p=0.011). ...