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FDA denies bid by Alimera Sciences to market Iluvien implant for DME

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ATLANTA — Amid concerns about long-term safety, efficacy and manufacturing standards, the U.S. Food and Drug Administration has denied a new drug application from Alimera Sciences to market Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema.

In a Complete Response Letter (CRL) to Alimera Sciences, the FDA requested additional data from the fluocinolone acetonide in diabetic macular edema (FAME) study, which comprised two phase 3 pivotal clinical trials to gauge the safety and efficacy of Iluvien, according to a news release from the company.

"It is important to point out that no new clinical studies were requested in the CRL," Dan Myers, president and chief executive officer for Alimera Sciences, said in a conference call with media and investors.

Alimera's new drug application, submitted June 29, included analysis of safety and efficacy data compiled through 24 months of the FAME study. The FDA requested data analyses performed through 36 months. According to the news release, Alimera has completed month 36 of the study and is preparing the requested analyses.

"We believe we can address the agency's requests with a resubmission in the first quarter and that we have a clear path to approval," Mr. Myers said in the call.

"We have already submitted a request to the FDA for a Type A meeting in early February to obtain additional clarity as to its recommendations," he said.

In addition, the FDA requested information concerning controls and specifications related to the manufacturing, packaging and sterilization of Iluvien. The FDA also identified shortcomings in good manufacturing practices during inspections of two third-party manufacturing facilities conducted in August and September. The third-party manufacturers are working to correct the deficiencies, according to the release.

The FAME study, which included 956 patients and was conducted at centers in the United States, Canada, Europe and India, concluded in October.

The Iluvien implant is designed to deliver sustained therapeutic sub-microgram levels of fluocinolone acetonide for up to 36 months. Its 25-gauge insertion device is designed to create a self-sealing wound.