Chronic diabetic macula oedema (DME) treatment Iluvien, developed by Alimera Sciences, has obtained marketing authorization in Germany.
The decision, made by the Federal Ministry of Health of Germany, follows the successful completion of the Decentralized Regulatory Procedure (DCP). Iluvien was given a positive outcome from six Concerned Member States including Austria, France, Germany, Italy, Spain and Portugal.
The sustained release intravitreal implant delivers sub-microgram levels of fluocinolone acetonide for as long as 36 months. Latest clinical trials demonstrate that 38% of DME patients experienced an improvement in best-corrected visual acuity of 15 letters or more on the ETDRS chart.
Professor Albert Augustin, professor and chairman of the Department of Ophthalmology, Klinikum Karlsruhe, Germany, said, "Iluvien will be a timely and much needed addition to the German market. As the largest country in Europe with a growing incidence of diabetic macular oedema, it has more DME patients than any of the other six countries. The approval of ILUVIEN in Germany will have a significant impact for the many patients with this chronic, debilitating disease."
Dan Myers, president and CEO of Alimera Sciences, commented, "We are very pleased to receive German marketing authorization for Iluvien, our fifth of seven expected approvals in the European Union. Assuming the closing of our recently announced financing, we anticipate that we will launch Iluvien in Germany during the first quarter of 2013."