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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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November 17, 2014
11:46 EDTALIMAlimera Sciences' ILUVIEN receives marketing approval in Ireland
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10:02 EDTALIMOn The Fly: Analyst Initiation Summary
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08:55 EDTALIMAlimera Sciences initiated with a Buy at Summer Street
Target $12.
November 12, 2014
07:43 EDTALIMAlimera Sciences' Iluvien receives marketing authorization in Belgium
Alimera Sciences,announced that the Belgian Federal Agency for Medicines and Health Products has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Approval in Belgium marks the fourth European approval through the Repeat-Use application procedure and the 12th approval worldwide, including the recent U.S. approval for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. ILUVIEN is pending approval in an additional six European Union countries included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.

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