pSivida Corp. Reports Positive Regulatory Outcome For ILUVIEN; Moves To National Phase For Marketing Authorizations In 10 More EU Countries

pSivida Corp.

, a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the regulatory process for marketing authorizations in Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Poland and Sweden has entered the national phase following the successful completion of the Mutual Recognition Procedure (MRP) for subsequent authorizations. In the national phase, each of these countries will grant a marketing authorization for ILUVIEN for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. ILUVIEN initially received marketing authorizations in Austria, France, Italy, Portugal, Spain as well as the United Kingdom and Germany where it is now commercially available. The application was submitted through the Mutual Recognition Procedure (MRP). After a medicine is first authorized in one EU member state in accordance with its national procedures, the same authorization can be subsequently used to obtain marketing authorization in other member states not involved in the original, authorization. These member states agree to recognize the validity of the original national marketing authorization. “Continuing to expand the countries where ILUVIEN can reach patients with this devastating disease is important, and we look forward to the addition of these ten countries,” said Dr. Paul Ashton, president and chief executive officer of pSivida. Alimera also resubmitted the New Drug Application for ILUVIEN for chronic DME in March 2014, and the U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of September 26, 2014. If ILUVIEN is approved by the FDA, we are entitled to a $25 million milestone payment from our licensee Alimera Sciences. We are also entitled to share in the net profits from Alimera's sales of ILUVIEN on a country-by-country basis.