Alimera Sciences, Inc., ALIM today announced the positive outcome of the Decentralized Procedure for ILUVIEN® in Europe. The announcement follows the issuance of the Final Assessment Report from the Reference Member State, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the agreement of all the Concerned Member States that ILUVIEN is approvable.
The regulatory process will now enter the national phase of the DCP in which the RMS and each CMS grants its national license. The CMS include Austria, France, Germany, Italy, Portugal and Spain. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
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