pSivida (PSDV) Completes Enrollment of Second Medidur Phase 3
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pSivida Corp. (Nasdaq: PSDV) announced that its second Phase 3 trial of Medidur in chronic, non-infectious posterior segment uveitis met its target enrollment of 150 patients. The trial is being conducted in clinical sites in India, with the same study design and endpoints as the first Phase 3 trial conducted in the US, EU and India. The results of both Phase 3 trials will support US product registration, with NDA submission planned for the second half of 2017. Filing for EU registration remains on track for the first calendar quarter of 2017.
“We are very pleased that the second Phase 3 trial of Medidur in posterior segment uveitis has met its patient enrollment goal on target and as expected,” said Nancy Lurker, President and CEO of pSivida Corp. “Both Phase 3 trials are generating efficacy and safety data critical to regulatory filings in support of product registration. Reaching today’s milestone brings us a step closer to making Medidur available to thousands of patients battling with recurrent episodes of ocular inflammation and the prospect of losing vision irreversibly.”
This first Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior segment uveitis at six months in December 2015. Primary efficacy endpoint readout in the second study is expected in the second half of 2017.
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