FDA to review Alimera's Iluvien

Alimera Sciences Inc. (NASDAQ:ALIM) and partner pSivida Corp. (NASDAQ:PSDV; ASX:PVA) said FDA accepted for review a resubmitted NDA from Alimera for Iluvien fluocinolone acetonide intravitreal implant to treat chronic diabetic macular edema (DME). FDA designated the NDA a Class 2 resubmission, with an Oct. 17 PDUFA date. Alimera has rights to the injectable insert delivering fluocinolone acetonide (FA) to the retina, which it markets in the U.K., from pSivida.

FDA has issued two complete response letters for Iluvien, the most recent of which came in November 2011 and asked for two additional clinical trials due to "significant" risks of adverse events in the Phase III FAME trials. However, 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 narrowed the indication of the NDA 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. ...