Alimera Sciences Resubmits Iluvien New Drug Application To FDA - Quick Facts

(RTTNews) - Alimera Sciences Inc. (ALIM) announced Thursday that it has resubmitted its New Drug Application for Iluvien to the U.S. Food and Drug Administration or FDA.

At this time, the company said it awaits the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. The company 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.

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.

Iluvien has received marketing authorizations in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the United Kingdom and Germany.

Iluvien is indicated for the treatment of vision impairment associated with chronic diabetic macular edema or DME considered insufficiently responsive to available therapies. Iluvien has not been approved for sale in the United States.