Alimera Sciences Announces Sept 26th PDUFA Date for ILUVIEN

Alimera Sciences, Inc. ALIM (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its recent resubmission of the New Drug Application (NDA) for ILUVIEN® has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's October 2013 letter and that a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 has been established. In the resubmission, Alimera 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 achieved our goal of resubmitting our NDA in the first quarter and to have a PDUFA goal date set for a decision from the FDA," said Dan Myers, Alimera's president and chief executive officer. "We look forward to the FDA's response to our NDA and hope that we will be able to make ILUVIEN available to patients in the United States who are suffering from chronic DME."