FDA declines to approve Iluvien

ATLANTA — The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

In its complete response letter, the FDA requested additional safety and efficacy data for the drug, Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema, a problem that commonly affects people with diabetes.

The agency also reported that it had found problems with current good manufacturing practices during inspections in August and September 2010 of plants operated by two of Alimera’s third-party manufacturers. According to Alimera, the manufacturers are in the process of resolving the problems.

A complete response letter means that the FDA has finished reviewing an approval application for a drug but issues remain that preclude final approval.

“We appreciate the FDA’s efforts to complete a priority review of our NDA and look forward to working closely with the FDA toward approval of Iluvien for the treatment of DME,” said Dan Myers, Alimera president and CEO. “To expedite the process, we have requested a meeting with the FDA to clarify the path to regulatory approval.”

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