pSivida Corp. (NASDAQ:PSDV - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The Spanish authorization is the sixth national approval for ILUVIEN in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany. pSivida's licensee Alimera Sciences, Inc. reported that it continues to work closely with the Italian regulatory authorities to secure marketing authorization in Italy. These marketing authorizations follow the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Member States (CMS).
Dr. Paul Ashton, President and CEO, said, "We are pleased that ILUVIEN has now been granted marketing authorizations in six of the seven EU countries in which approval has been sought and look forward to its commercial launch in the EU."
Alimera reported that it continues to expect the initial commercial launch of ILUVIEN in Germany during the first quarter of 2013 with its European management team now on board.
The International Diabetes Federation estimates that more than three million people are currently living with diabetes in Spain, approximately 160,000 of whom Alimera estimates suffer from vision loss associated with DME.