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After completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME(TM) (Fluocinolone Acetonide in Diabetic Macular Edema) Study can continue under the current protocol, without change. The trial is studying the use of Medidur FA for the treatment of diabetic macular edema (DME). FAME is two, duplicate, double-masked, randomized, multi-center studies 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 two years of follow-up. Enrollment for the FAME study was completed in October 2007. "Alimera is pleased with the response from the DSMB that they have once again recommended that our investigative efforts around this treatment continue without change to the current protocol," said Alimera CEO Dan Myers. As of this latest DSMB review, we continue to be on track for regulatory submissions in early 2010." Earlier this month, Alimera announced that it would be assuming a majority stake in the development of Medidur FA. Alimera is also working with Emory University on an exploratory treatment using the Medidur delivery system with an NADPH oxidase inhibitor for the treatment of dry age-related macular degeneration (AMD). Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting. Currently, 7.5 percent of the U.S. population has diabetes. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. In the United States, as many as 200,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved drug treatments for DME. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing studies. The FAME DSMB, a group comprised of four ophthalmologists and a biostatistician, met to review the Medidur FA Phase III clinical trial data. The DSMB's charter stipulates that a formal review occur every six months in addition to their ongoing review of the trial.
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