Alimera Sciences, today reported that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase 3 clinical trials for the use of Iluvien(TM) in the treatment of diabetic macular edema (DME).
Alimera's Iluvien is an intravitreal insert being developed for the treatment of DME. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose.
Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
The Board completed its final review of the currently available safety and efficacy data prior to the readout in October 2009.
These clinical trials, known collectively as the FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multi-center trials in the U.S., Canada, Europe and India in support of a planned global registration filing. Safety and efficacy will be assessed after 24 months of follow-up, which will occur in October of this year.