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Iluvien granted marketing authorization in Sweden

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The Swedish Medical Products Agency has granted marketing authorization to Iluvien for the treatment of chronic diabetic macular edema-associated vision impairment in patients unresponsive to other available therapies, according to an Alimera Sciences press release.

The approval in Sweden marks the third granting Iluvien (190 mcg intravitreal implant in applicator) marketing approval under the company’s Repeat-Use Procedure application.

Iluvien 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, according to the press release.

Iluvien has not been approved in the United States. The U.S. Food and Drug Administration is currently reviewing a new drug application for the chronic DME treatment.