pSivida (PSDV) Completes Enrollment of Second Medidur Phase 3
- Record-setting rally pushes on as S&P ends week up 3 percent
- Trump's Cohn Pick Most Bullish Sign Yet for Banks - Cowen
- Unusual 11 Mid-Day Movers: (IDXG) (INVN) (EBS) Higher; (SCON) (DTEA) (DLTH) Lower (more...)
- 21st Century Fox (FOXA) offers to acquire Sky for GBP10.75/share
- Coca Cola (KO) Announces James Quincey to Succeed Muhtar Kent as CEO; Kent to Continue as Chairman
Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.
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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Whirlpool (WHR) Announces U.S. Confirms Samsung and LG Dumped Washers
- Axis Capital (AXS) Approves $1B Buyback of Common Shares
- Coty (COTY) Raises Quarterly Dividend 81.8% to $0.125; 2.6% Yield
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Related EntitiesTwitter, Dividend
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!