Iluvien regulatory update

Alimera said in its 2Q12 earnings that it plans to resubmit an NDA to FDA for diabetic macular edema (DME) drug Iluvien fluocinolone acetonide intravitreal implant using available data from the Phase III FAME trials instead of conducting 2 additional clinical trials requested by the agency in a November complete response letter (see BioCentury, Nov. 14, 2011). The decision is based on a June meeting with FDA discussing the letter. Alimera said the resubmission will focus on the population of patients with chronic DME considered insufficiently responsive to available therapies, for which the product is approved in Austria, Portugal, the U.K., France and Germany. Decisions in Spain and Italy are pending. Alimera plans to launch Iluvien in Germany in 1Q13, with launches in the U.K. and France later that year. ...