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DSMB Again Supports Continuation of Alimera Sciences' Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
Date:9/24/2008

ATLANTA, Sept. 24 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has again recommended that the two pivotal Phase 3 clinical trials for the use of Iluvien(TM) in the treatment of diabetic macular edema (DME) continue under the current protocol, without change. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.

These clinical trials, known collectively as the FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two double masked, randomized, multi-center trials that are following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after 24 months of follow-up. Enrollment for the FAME study was completed in October 2007.

"Alimera is excited about the potential of Iluvien to help the growing number of people suffering from DME," said Alimera CEO Dan Myers. "The DSMB's recommendation to continue the FAME Study without change keeps the development for Iluvien on track for regulatory submissions in early 2010."

Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. 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 injec
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SOURCE Alimera Sciences
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