Alimera Sciences announced that it has entered into labeling discussions with the U.S. FDA for Iluvien and, as a result, reached an agreement with the FDA that Alimera's participation in the January Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary. Alimera will focus instead on drafting its response to the Complete Response Letter received from the FDA in October with a goal of submitting the response in Q1. The FDA has indicated that Alimera will not be required to conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval. In addition to the U.K., Iluvien is being sold in Germany and is expected to launch in France in 2014. In addition, Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the U.K. as the Reference Member State for 10 additional European Union country approvals through the Mutual Recognition Procedure.
- Pharmaceuticals & Drug Trials