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DME treatment receives marketing authorization in Austria

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ATLANTA — The Austrian Agency for Health and Food Safety has given marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema that is insufficiently responsive to available therapies, Alimera Sciences announced in a press release.

The approval in Austria is the first national authorization of Iluvien (sustained-release fluocinolone acetonide) in the European Union, according to the release.

It follows the successful completion of the Decentralized Regulatory Procedure, which included positive outcomes from the United Kingdom, the reference member state, and Austria, France, Germany, Italy, Spain and Portugal, the six concerned member states.

In November, the U.S. Food and Drug Administration called for two more clinical trials to answer questions about Iluvien. It said Alimera’s application did not offer sufficient data supporting the safety and efficacy of Iluvien.