pSivida reports that Alimera Sciences gets FDA Complete Response Letter for ILUVIEN NDA

Oct 18 2013

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that its licensee Alimera Sciences, Inc. has received a Complete Response Letter (CRL) for the New Drug Application (NDA) for ILUVIEN® from the U.S. Food and Drug Administration (FDA).

Identifying concerns regarding the benefit to risk and safety profiles of ILUVIEN, the FDA stated that the NDA could not be approved in its present form. To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients. The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee may be of assistance in addressing the deficiencies identified above and providing advice whether a patient population can be identified in which the benefits of the drug product might outweigh the risks. Alimera reported that in a separate written communication from the staff of the FDA, it was notified that an Advisory Committee meeting would be convened on January 27, 2014. In the CRL, the FDA also referenced deficiencies at the facility where ILUVIEN is manufactured.

"We are extremely disappointed by the FDA's decision not to approve ILUVIEN at this time," said Paul Ashton, PhD, president and chief executive officer of pSivida. "However, we are pleased that Alimera plans to continue to work with the FDA, through the advisory committee, to determine whether there is a path forward in the U.S. for ILUVIEN, and that Alimera believes it is well positioned for growth in Europe, irrespective of the U.S. outcome, based on current traction in the countries in which ILUVIEN has already been approved, coupled with the continued pursuit of further country approvals."

Alimera reported that its commercial focus is on Europe, where the ILUVIEN is approved and commercially available in the United Kingdom and Germany and slated to launch in France early next year. ILUVIEN is also approved in Austria, Portugal and Spain and pending approval in Italy. In addition, Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (U.K.) as the Reference Member State for 10 additional European Union country approvals through the Mutual Recognition Procedure.