Alimera Sciences, Inc. (ALIM), a biopharmaceutical company specializing in prescription ophthalmic pharmaceuticals, Monday said that FDA has acknowledged the resubmission of its new drug application for Iluvien and has established September 26 as the Prescription Drug User Fee Act, or PDUFA, date.
Iluvien is an intravitreal implant for the treatment of vision impairment linked with chronic diabetic macular edema (DME). The application is commercially available in the U.K. and Germany.
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