30.06.2014 14:01:35

PSivida Says Iluvien Gets Marketing Authorizations In 10 More EU Countries

(RTTNews) - pSivida Corp. (PSDV), Monday said ILUVIEN has been granted marketing authorizations in Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Poland and Sweden. This was following the successful completion of the Mutual Recognition Procedure for subsequent authorizations. In the national phase, each of these countries will grant a marketing authorization for Iluvien, which is an injectable, sustained release micro-insert used for the treatment of chronic DME considered insufficiently responsive to available therapies, and is licensed to Alimera Sciences, Inc. (ALIM). Currently, Iluvien is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Italy, Portugal and Spain. Alimera has filed for ten additional EU country approvals through the Mutual Recognition Procedure. After a medicine is first authorized in one EU member state as per the national procedures, the same authorization can be subsequently used to obtain marketing authorization in other member states. Alimera also resubmitted the New Drug Application for Iluvien for chronic DME in March 2014, and the U.S. Food and Drug Administration has set a PDUFA goal date of September 26, 2014. If Iluvien is approved by the FDA, Psivida is entitled to a $25 million milestone payment from our licensee Alimera Sciences.

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