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news.Alimera has reported that an independent Data Safety Monitoring Board has once again recommended that the two pivotal Phase III clinical trials, known collectively as the Fame study can continue under the current protocol, without change.
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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.”