March 24, 2008 – 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™ (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's Press Release -
[PDF] pSivida's Press Release -
