pSivida Receives CRL from FDA for ILUVIEN

pSivida Corp.

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