Alimera's Iluvien approved in Portugal

Portugal’s National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saude, Infarmed) has granted marketing authorization for US drugmaker Alimera Sciences’ (Nasdaq: ALIM) Iluvien (fluocinolone acetonide intravitreal insert) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The drug is licensed from pSivda Corp, a leader in developing sustained-release, drug delivery products for treatment of back-of-the-eye diseases.

This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) 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 Portuguese authorization is the third national approval in the EU, preceded by Austria and the UK. The US Food and Drug Administration has so far rejected approval of the product (The Pharma Letter November 14, 2011).