Alimera, pSivida slide on Iluvien complete response

Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) both fell on Friday after FDA issued a complete response letter for an NDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema. Alimera said FDA cited concerns with the benefit-risk and safety profile of Iluvien and requested an additional clinical trial plus at least 12 months of follow-up. The company said it will meet with FDA's Dermatologic and Ophthalmic Drug Advisory Committee in January for advice on addressing the agency's concerns and on whether a patient population can be identified in which the benefits of Iluvien outweigh its risks.

The complete response letter is the third from FDA for Iluvien. In its previous November 2011 letter, FDA had asked for two additional clinical trials of Iluvien due to "significant" risks of adverse events in the Phase III FAME trials. Based on a meeting with FDA, Alimera did not conduct the trials and resubmitted the NDA with additional analysis of the FAME trials. The company also had narrowed the indication to the subgroup of patients with chronic DME, for which Iluvien is already approved in Austria, Portugal, the U.K., France and Germany. Previously, Alimera had been seeking approval of Iluvien for all DME patients. ...