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Alimera Sciences Inc. resubmitted its new drug application, or NDA, for an investigational intravitreal insert containing fluocinolone acetonide (Iluvien) to the FDA May 12.
Atlanta-Alimera Sciences Inc. resubmitted its new drug application, or NDA, for an investigational intravitreal insert containing fluocinolone acetonide (Iluvien) to the FDA May 12.
This resubmission attempts to address the FDA's request for analyses of the safety and efficacy data through month 36 of Alimera’s FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study and includes subgroup data that were presented recently at the annual meeting of the Association for Research in Vision and Ophthalmology, according to the company. In addition, the resubmission includes more information regarding controls and specifications about the manufacturing, packaging, and sterilization of the drug, which was requested by the FDA.
“We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of [the fluocinolone acetonide insert] and address the FDA's additional issues,” said Dan Myers, Alimera’s president and chief executive officer. “We look forward to working with the FDA for a prompt review and response.”
According to the FDA’s classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act, FDA review of a Class 2 resubmission is expected to be completed within a 6-month period beginning on the date that the resubmission is received.