ATLANTA, July 26, 2012 /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the Federal Ministry of Health of Germany (Bundesministerium fur Gesundheit, BfArM) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP), 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 Members States (CMS), which include Austria, France, Germany, Italy, Spain and Portugal. The German authorization is the fifth national approval in the EU, preceded by Austria, Portugal, the U.K. and France.
"We are very pleased to receive German marketing authorization for ILUVIEN, our fifth of seven expected approvals in the European Union," said Dan Myers, president and chief executive officer, Alimera Sciences. "Assuming the closing of our recently announced financing, we anticipate that we will launch ILUVIEN in Germany during the first quarter of 2013."
The International Diabetes Federation estimates that more than 5 million people are currently living with diabetes in Germany, and according to Alimera's estimates, more than 215,000 people suffer from vision loss associated with DME.ILUVIEN is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.