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pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced financial results for its second quarter ended December 31, 2012.
“We are pleased with the progress of our lead development product, an injectable micro-insert for posterior uveitis. We expect to begin Phase III trials early next quarter on schedule,” said Dr. Paul Ashton, President and CEO. “We intend these trials to form the basis for a future NDA submission and are excited about the role this product could play in treating this serious, underserved disease. The investigator-sponsored Phase II clinical study of this micro-insert in this disease has completed enrollment ahead of schedule and has been expanded to allow the treatment of more patients.”
“Because our posterior uveitis product uses the same micro-insert as ILUVIEN®, which has received marketing authorizations in various EU countries for chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies, and delivers the same drug as our surgically implanted Retisert® product already approved for posterior uveitis, we expect our Phase III trials will show efficacy similar to Retisert but with a side-effect profile in uveitis patients comparable to that seen in DME patients. We are optimistic therefore that our micro-insert will be efficacious for posterior uveitis, but with fewer side effects and a favorable risk/benefit profile compared to Retisert,” continued Dr. Ashton. “The U.S. Food and Drug Admnistration’s (FDA) decision to allow us to reference much of the ILUVIEN data for DME, including the clinical safety data, from Alimera Sciences’ already-completed pivotal Phase III clinical trials, has the potential to both simplify any future NDA submission and to shorten development time. We are planning to target enrollment of a total of 300 patients in our two trials, with a primary end point of recurrence of uveitis at 12 months.”