Iluvien receives marketing approval in Denmark for chronic DME
The Danish Health and Medicines Authority has granted marketing approval of Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema, according to an Alimera press release.
Denmark is the second country to grant national marketing authorization for Iluvien (190 mcg intravitreal implant in applicator, Alimera). The U.S. Food and Drug Administration is currently reviewing the company’s new drug application.
The intravitreal implant is also 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 under the Repeat-Use Procedure application in an additional eight countries, according to the release.