pSivida Announces September 26, 2014 PDUFA Date for ILUVIEN

pSivida Corp.

, a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 for ILUVIEN® following the recent resubmission of the New Drug Application (NDA) by pSivida's licensee, Alimera Sciences. The FDA acknowledged the resubmission as received as a complete class 2 response to the FDA's October 2013 complete response letter. The resubmission responded to questions raised in the FDA's October 2013 letter and provided data from ILUVIEN patients and from physician experience with the applicator in the United Kingdom and Germany where ILUVIEN is currently commercially available. “We are pleased to have the PDUFA goal date set for ILUVIEN and look forward to the FDA's action on the resubmitted NDA,” said Paul Ashton, pSivida's president and chief executive officer.