pSivida resubmits New Drug Application for ILUVIEN

Mar 27 2014

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration (FDA). In the resubmission, pSivida's licensee, Alimera Sciences, responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe.

Alimera is awaiting the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. pSivida will report that information when it becomes available.

"We are pleased with the resubmission of the NDA for ILUVIEN, which brings us one step closer to potential approval in the United States," said Paul Ashton, pSivida's president and chief executive officer.