Iluvien regulatory update

Alimera said the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) approved Iluvien to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The MAA for Iluvien was submitted under the EU's decentralized procedure, with the U.K. acting as the reference member state, and Austria, France, Germany, Italy, Portugal and Spain acting as the concerned member states. The approval is the second in the EU for the product following approval in Austria last month. Alimera, which said it expects additional marketing approvals "in the coming months," said it plans to launch Iluvien by year end (see BioCentury, April 30). ...