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Alimera Sciences, Inc.(Alimera), a biopharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, has resubmitted its New Drug Application for Iluvien to the US Food and Drug Administration (US FDA). At this time, Alimera awaits the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. Alimera intends to provide that information when it becomes available.
In the resubmission, Alimera responded to questions raised in the FDA's October 2013 complete response letter and provided a safety update, which included commercial experience with Iluvien in Europe.
"We are pleased to resubmit Iluvien for approval in the United States," said Dan Myers, Alimera's president and chief executive officer. "We look forward to an acknowledgment from the FDA that the response is complete and that a PDUFA date has been confirmed."
Iluvien (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant that provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In Alimera's FAME Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
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