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Alimera Sciences resubmits new drug application
ATLANTA — Alimera Sciences has resubmitted a new drug application for fluocinolone acetonide implants to address a complete response letter from the U.S. Food and Drug Administration, the company announced in a press release.
The resubmission includes 36-month data from the FAME Study, which evaluated the safety and efficacy of Iluvien (sustained release fluocinolone acetonide). Alimera has included new data from a subgroup population, as well as more information about controls, the release said.
Because the FDA observed deficiencies in current good manufacturing practices while conducting facility inspections, further information on specifications about manufacturing, packaging and sterilization were also included in the resubmission.
The resubmission should be completed within 6 months after it is received by the FDA, the release said.