pSivida (PSDV) Gets MHRA MAA Approval for ILUVIEN in Europe
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pSivida Corp. (Nasdaq: PSDV) announced the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has granted marketing authorization for ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Additional CMS marketing authorizations are expected in the coming months and Alimera has reported it continues to expect ILUVIEN to be available in the EU by the end of 2012.
This marketing authorization follows the recently announced approval in Austria. These approvals were preceded by completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the MHRA, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States, specifically Austria, France, Germany, Italy, Spain and Portugal.
This marketing authorization follows the recently announced approval in Austria. These approvals were preceded by completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the MHRA, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States, specifically Austria, France, Germany, Italy, Spain and Portugal.
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