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FDA declines to approve Iluvien for diabetic macular edema
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ATLANTA — The U.S. Food and Drug Administration has issued a complete response letter to Alimera Sciences for its investigational sustained drug delivery system Iluvien, effectively denying approval at this time, according to a press release.
The letter notes that Alimera's application did not offer sufficient data supporting the safety and efficacy of Iluvien (sustained-release fluocinolone acetonide) for treatment of diabetic macular edema, the press release said. The FAME study demonstrated that risks of adverse reactions from Iluvien were significant and were not offset by Iluvien's benefits, according to the letter.
The FDA's Center for Drug Evaluation and Research issues a complete response letter when it finishes its review of a new drug application but has further questions that must be answered before it can approve the drug.
The FDA is calling for two more clinical trials to answer its concerns, the press release said.
"We are surprised and disappointed with the FDA's decision on our application to market Iluvien in the U.S. to patients with this devastating disease," Dan Myers, president and CEO of Alimera, said in the release. "Based on extensive research with U.S. retinal physicians, we have learned that Iluvien's long-term sustained delivery treatment benefit is desired and that Iluvien has a manageable risk-to-benefit ratio. We continue to believe in Iluvien as a long-term effective treatment option for DME. We are committed to, and have the funds for, pursuing approval in Europe and for evaluating our options in the U.S."
Alimera expects notification in 2012 on whether Iluvien will be approved in Europe, the release said.