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 US, 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.
The Fame Data Safety Monitoring Board (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.
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. 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.
Dan Myers, CEO of Alimera, said: “As of this latest DSMB review, we continue to be on track for regulatory submissions in early 2010.”