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 fourth quarter and fiscal year ended June 30, 2013.
“In fiscal 2013, we made a major step forward in our transition to a Specialty Pharma company with the start of the first of two planned pivotal Phase III clinical trials for our own lead development product, the micro-insert Medidur™ for posterior uveitis,” said Dr. Paul Ashton, President and CEO of pSivida. “Uveitis is the third leading cause of blindness in the U.S. Because Medidur uses the same micro-insert as ILUVIEN® , our partnered product for diabetic macular edema (DME), the FDA has agreed that we can use much of the data, including clinical safety data, from the completed ILUVIEN Phase III trials to support an application for Medidur for posterior uveitis. This should shorten and simplify the regulatory process.
“We also received encouraging interim results from a Phase I/II investigator-sponsored study of Medidur for posterior uveitis. While early, they were consistent with our hypothesis that Medidur should treat posterior uveitis with an efficacy profile comparable to Retisert®, our FDA-approved implant for uveitis that delivers the same drug as Medidur, and a side effect profile superior to Retisert and comparable to ILUVIEN for DME.”
ILUVIEN for chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, is now being sold in Germany and the U.K., and Alimera has reported its plans for a commercial launch in France in early 2014. ILUVIEN for DME has also received marketing authorization in Austria, Portugal and Spain, and has been recommended for marketing authorization in Italy. In the U.S., the FDA is reviewing the New Drug Application for ILUVIEN for DME resubmitted earlier this year and has set a Prescription Drug User Fee Act (PDUFA) target date of October 17, 2013. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera. pSivida is also entitled to 20% of net profits, as defined, from sales of ILUVIEN by Alimera on a country-by-country basis.