Industry News — Clinical Updates
Iluvien Receives Marketing Authorization in Sweden for Chronic DME
The Swedish Medical Products Agency has granted marketing authorization to Iluvien (sustained-release fluocinolone acetonide implant; Alimera Sciences, Inc, Atlanta, GA) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Sweden is the tenth country in Europe to grant national marketing authorization for Iluvien. It is also approved for marketing in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain, and the United Kingdom, and it is commercially available in the United Kingdom and Germany. Iluvien is pending approval in an additional seven European countries, and a new drug application is under review by the US Food and Drug Administration (FDA).
Updated September 3, 2014