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Diabetic macular edema treatment closer to approval in Europe
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ATLANTA — Alimera Sciences is closer to marketing Iluvien as a treatment for diabetic macular edema in Europe following a positive response to the treatment's decentralized procedure application, according to a company press release.
The concerned member states named in the application — Austria, France, Germany, Italy, Portugal and Spain — have agreed that Iluvien (sustained-release fluocinolone acetonide) is approvable, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom agreed, the release said.
"Achieving a favorable conclusion for Iluvien in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," Dan Myers, president and CEO of Alimera Sciences, said in the release. "We will continue to work closely with the U.K. and the concerned member states to ensure that Iluvien is made available to patients as soon as possible."
The next step is for each nation to grant a license, the release said.
In November, the U.S. Food and Drug Administration did not grant approval for Iluvien for the treatment of diabetic macular edema due to insufficient data supporting the safety and efficacy of the drug.
The FDA asked for further clinical trials to demonstrate whether risks of adverse reactions from Iluvien were offset by its benefits.