US biopharma company Alimera Sciences (Nasdaq: ALIM) says that the Spanish Agency of Drugs and Medical Devices has granted marketing authorization to Iluvien (fluocinolone acetonide intravitreal insert) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure in the European Union, in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, serving as the Reference Member State, delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The Spanish authorization is the sixth national approval in the EU, preceded by Austria, the UK, Portugal, France and Germany.
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