Positive Data Presented at the Association for Research in Vision and Ophthalmology Annual Meeting

pSivida Anticipates Reporting Top Line Results from the Second Pivotal Phase 3 Clinical Trial in June 2017

WATERTOWN, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced positive 12-month follow-up data for the Company's Durasert three-year treatment for posterior segment uveitis, which was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting.  The data is from the Company's first Phase 3 trial.
  • Durasert three-year uveitis implant demonstrated a significant reduction in the recurrence of posterior segment uveitis through 12 months.
  • 27.6% of Durasert treated patients had a recurrence compared to 85.7% of patients in the sham group (p<0.001).
  • The Best Corrected Visual Acuity (BCVA) gain of 15 letters or more at six and 12 months was 23% and 22.4%, respectively, for Durasert and 7.3% and 10.3%, respectively, for sham, demonstrating sustained effect over 12 months.
  • Intraocular pressure (IOP) elevation, which can lead to glaucoma, at 12 months was 1.3mm mean for Durasert vs 0.2mm mean for sham. Patients requiring IOP-lowering therapy at 12 months were 26.4% for Durasert and 26.2% for sham.
  • In phakic patients at baseline, 33.3% in the Durasert group required a cataract surgery through 12 months compared to 4.8% in the sham group; Phakic refers to patients with a natural lens vs those who have had cataract lens replacement surgery.

The data was presented by Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC.   Dr. Jaffe is a leading authority on posterior segment uveitis, a devastating disease and the third leading cause of blindness. A total of 129 patients were enrolled in the first Phase 3 clinical trial and the primary endpoint was prevention of recurrence of posterior uveitis at six months, with patients continuing to be followed for 36 months. To view Dr. Jaffe's entire presentation, please visit the Company's website at www.psivida.com, under 'News and Events,' and click on 'Presentation and Publications.'

"The data presented today by Dr. Jaffe continues to reinforce pSivida's proven technology and depth of our innovation," commented Nancy Lurker, President and Chief Executive Officer.  "The results, both at six and 12 months, demonstrated a significant reduction in the prevention of recurrence of posterior segment uveitis - a devastating disease and the third leading cause of blindness.  Our market research indicates strong interest in using the product driven by the results of our first Phase 3 clinical trial demonstrating a significant, and durable, reduction in recurrence rates, improvements in BCVA and a favorable tolerability profile at 12 months. We continue to expect the first read-out of our second Phase 3 clinical trial of Durasert and submission of the European Market Authorization Application (MAA) by the end of June.  We remain on track to also file a New Drug Application (NDA) with the FDA in the calendar fourth quarter of 2017."

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