Industry News — Clinical Updates

Iluvien Receives Marketing Authorization in Norway for Chronic DME

The Norwegian Medicines Evaluation Board 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.

Norway is the first country to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application.

In addition to Norway, Iluvien is approved for marketing in Austria, France, Germany, Italy, Portugal, Spain, and the United Kingdom, and it is commercially available in the United Kingdom and Germany. Iluvien is pending approval in an additional 9 countries included in the Repeat-Use Procedure: Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Poland, and Sweden.

Iluvien has also been approved for reimbursement in Portugal by INFARMED, the marketing authorization body of the Portuguese Ministry of Health. Alimera plans to move forward with commercialization in Portugal in late 2014.

Iluvien is under review by the US Food and Drug Administration (FDA).

Updated July 29, 2014