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Iluvien earns marketing authorization in Ireland

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Alimera Sciences announced that marketing authorization has been granted to Iluvien in Ireland.

Through the repeat use application procedure, the Irish Health Products Regulatory Authority granted marketing authorization to Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of vision impairment associated with chronic diabetic macular edema that is unresponsive to available therapies, according to a company press release.

The U.S. Food and Drug Administration approved Iluvien in September 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 IOP.

The implant is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany, according to the release.