Alimera, pSivida jump on Iluvien update

Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) jumped in early after-hours trading after the partners said late Wednesday that FDA indicated Alimera will not need to conduct a new clinical trial prior to approval of Iluvien fluocinolone acetonide intravitreal implant for diabetic macular edema (DME). In October, FDA issued a third complete response letter in which Alimera said the agency cited concerns with Iluvien's benefit-risk and safety profile and requested an additional clinical trial, plus at least 12 months of follow-up. Next quarter, Alimera plans to submit a response that the company said will address the agency's concerns and will include additional safety data from the U.K. and Germany, where Iluvien is marketed. Alimera also said it entered labeling discussions with FDA for Iluvien and that the parties agreed a January meeting of FDA's Dermatologic and Ophthalmic Advisory Committee for advice on the agency's concerns is no longer necessary (see BioCentury Extra, Oct. 18). ...