Alimera Sciences Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced the positive outcome of the Repeat-Use Procedure for Iluvien for the treatment of chronic diabetic macular edema (DME) in an additional 10 European Union countries. Alimera submitted the application through the Mutual Recognition Procedure (MRP) with the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) serving as the Reference Member State.
The regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland and the Czech Republic, will now enter the national phase in which each country grants marketing authorization. Iluvien will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
“Achieving a favorable outcome for Iluvien in these additional EU countries is a significant milestone for Alimera and very encouraging for the many patients throughout Europe with this devastating disease,” said Dan Myers, president and chief executive officer, Alimera. “We will continue to work closely with these countries during the national phase to obtain Iluvien marketing authorization in each one.”
Date: June 30, 2014
Source: Alimera Sciences
Filed Under: Drug Discovery
