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. About pSivida Corp. pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorization in Italy. ILUVIEN for DME has not been approved in the U.S. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's two FDA-approved products, Retisert® and Vitrasert®, are implants that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina.