pSivida (PSDV) Gets MAA Approval for ILUVIEN in Austria
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pSivida Corp. (Nasdaq: PSDV) announced the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) has granted marketing authorization to ILUVIEN 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 (DCP), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State, delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), which include Austria, France, Germany, Italy, Spain and Portugal. The Austrian authorization is the first national approval in the EU. 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 completion of the Decentralized Regulatory Procedure (DCP), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State, delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), which include Austria, France, Germany, Italy, Spain and Portugal. The Austrian authorization is the first national approval in the EU. 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.
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