Iluvien receives national marketing authorization in 10th country

September 9, 2014

The Swedish Medical Products Agency has granted marketing authorization of Alimera Sciences’ Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Atlanta-The Swedish Medical Products Agency has granted marketing authorization of Alimera SciencesIluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

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Sweden is now the tenth country to grant national marketing authorization to the treatment.

In addition to Sweden, the treatment is now approved for marketing in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain, and the United Kingdom, and is commercially available in the United Kingdom and Germany.

The treatment is pending approval in an additional seven countries included in Alimera's Repeat-Use Procedure application. These countries are Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, and Poland. A new drug application for the treatment is currently under review by the FDA.

"Sweden is now the third country to grant marketing authorization for (the treatment) from our Repeat-Use Procedure application,” said Dan Myers, Alimera's president and chief executive officer. “As DME is often a disease that persists, we are excited by the prospect of enabling retinal physicians in additional countries to provide their patients with the only 3-year treatment for DME.

 

"We look forward to continuing to expand our geographic presence in Europe through additional national marketing authorizations,” he continued.

 

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