pSivida Corp Reports Alimera Sciences’s Intention to Resubmit Application to FDA for ILUVIEN® in DME Using Data From Completed Trials
Published: Aug 01, 2012
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today reported that its licensee Alimera Sciences, Inc. has indicated its intention to resubmit its application for ILUVIEN® for diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA). Based on a recent meeting with the FDA, Alimera intends to use data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME® Study). pSivida expects the resubmission to address the issues raised by the FDA in its November 2011 Complete Response Letter (CRL) and in its recent meeting with Alimera.