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Alimera applies for 10 additional European Union country approvals for Iluvien

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Alimera Sciences anticipates a commercial launch of Iluvien in France in 2014 and has applied to the Medicines and Healthcare Products Regulatory Agency for 10 additional European Union country approvals, according to a press release.

“Europe offers the possibility of significant growth, and we believe the market opportunity in Europe is at least as large as that in the United States,” Dan Myers, Alimera president and CEO, said in a subsequent conference call.

Iluvien (sustained-release fluocinolone acetonide), for the treatment of diabetic macular edema, is currently sold in the United Kingdom and Germany. It is expected to be launched in France next year, has been approved in Austria, Portugal and Spain, and is pending approval in Italy.

In an effort to expand the sales of Iluvien, Alimera has applied to the Medicines and Healthcare Products Regulatory Agency for 10 additional European Union country approvals through the mutual recognition procedure.

In the United States, the U.S. Food and Drug Administration recently said it could not approve the new drug application for Iluvien due to clinical and statistical deficiencies, suggesting that the risks outweighed the benefits.

“I want to be very clear that the FDA’s current decision does not affect our efforts in Europe,” Myers said.
An FDA advisory committee meeting next year will address the situation.

“We look forward to the advisory meeting in January 2014, where we, together with retinal physicians, can discuss the benefits and risks of Iluvien in a public forum,” Myers said.