EU and US Calendar 2017 Registration Filing Milestones for Durasert™ for Posterior Segment Uveitis Remain on Schedule

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WATERTOWN, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today reported financial results for its fiscal 2017 third quarter and nine months ended March 31, 2017.  The Company's progress during the third quarter has set the stage for the achievement of several near-term goals during the remainder of calendar 2017 including:

Durasert™ Three-Year for Posterior Segment Uveitis:
  • Report top line results from the second pivotal Phase 3 clinical trial in June 2017.
  • Submit the European Market Authorization Application (MAA) in June 2017.
  • File an NDA in the U.S. during the fourth quarter of calendar 2017.
  • Pre-clinical safety and PK studies of its next generation shorter acting Durasert for posterior segment uveitis remain on track to commence in the second quarter of calendar 2017.
  • Present clinical study data at leading medical conferences, including the Association for Research in Vision and Ophthalmology (ARVO) annual meeting on May 8, 2017 and American Society of Retina Specialists (ASRS) annual meeting in August 2017.

Other Durasert Related Developments:
  • Full enrollment for the Phase I knee osteoarthritis (OA) investigator-sponsored clinical trial was achieved with Hospital for Special Surgery (HSS).  The Company expects HSS to report the initial 24-week data by the fourth quarter of calendar 2017.
  • The Company entered into a funded feasibility study agreement with a leading biopharmaceutical company in March 2017.  The Company expects to consummate one or more additional collaboration agreements in calendar 2017.

"We continue to make substantial regulatory, clinical and collaborative progress with our Durasert technology," commented Nancy Lurker, President and Chief Executive Officer.  "Our near-term goals remain: 1) unmask our second pivotal Phase 3 clinical trial for Durasert three-year uveitis and file regulatory approval applications in both the EU and US in calendar 2017, 2) establish additional collaboration partnerships for our proven Durasert technology, and 3) finalize an EU out-license partner for our three-year uveitis product candidate.  Our efforts to date are yielding promising results and the successful achievement of these upcoming milestones will demonstrate the potential of our moderate risk/nearer term product development programs."

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