DME treatment gains marketing authorization in Italy

Atlanta-The Italian Medicines Agency has granted marketing authorization to Alimera Sciences’ sustained-release intravitreal implant (Iluvien) for the treatment of chronic diabetic macular edema (DME).

The Italian authorization is the seventh national approval in the European Union, preceded by Austria, the United Kingdom, Portugal, France, Germany, and Spain.

The treatment is commercially available in the United Kingdom and Germany.

Designed as a C class product in Italy, the treatment will be available initially to private paying patients. Alimera is currently pursuing H Class designation with the Italian regulatory authorities, which, if granted, would expand patient access to the product.

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