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June 30, 2014
07:31 EDTALIMAlimera Sciences receives positive outcome for Iluvien in procedure
Alimera Sciences announced the positive outcome of the Repeat-Use Procedure for ILUVIEN for the treatment of chronic diabetic macular edema in an additional 10 European Union countries. Alimera submitted the application through the Mutual Recognition Procedure with the Medicines and Healthcare products Regulatory Agency of the United Kingdom serving as the Reference Member State. The regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland and the Czech Republic, will now enter the national phase in which each country grants marketing authorization. ILUVIEN will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
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