Alimera Sciences, Inc, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Danish Health and Medicines Authority has granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.
With Norway's approval earlier this month, Denmark is the second country to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application. In addition to Denmark, Iluvien is now approved for marketing in Austria, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom, and is commercially available in the United Kingdom and Germany. Iluvien is pending approval in an additional eight countries included in the Repeat-Use Procedure application. These countries are Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden. A new drug application for Iluvien is currently under review by the U.S. Food and Drug Administration.
"With Iluvien now approved for marketing in the second Scandinavian country, more patients can gain access across Europe to the only three-year treatment for DME, and the only treatment for the chronic form of the disease," said Dan Myers, Alimera's president and chief executive officer. "We look forward to continuing to expand our geographic footprint through additional national marketing authorizations."
For more details, go to: http://investor.alimerasciences.com/releasedetail.cfm?ReleaseID=863484