Atlanta-Alimera Sciences Inc. and pSivida Limited haveannounced that following a planned interim review, an independentData Safety Monitoring Board (DSMB) has recommended thecontinuation of their phase III clinical trial of Medidur.
Atlanta-Alimera Sciences Inc. and pSivida Limited have announced that following a planned interim review, an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of their phase III clinical trial of Medidur.
The DSMB met March 16 to review the Medidur phase III clinical trial data.
Medidur, a tiny, injectable device, is being studied as a way to deliver fluocinolone acetonide to the retina for up to 3 years to treat diabetic macular edema (DME).
"We are very pleased with the DSMB's conclusions and see this as a positive step toward the development of this novel treatment for DME," said Dan Myers, chief executive officer of Alimera Sciences. "We will now expand this phase of the masked, randomized, multicenter clinical trial in the United States, Canada, Europe, and India."
Gavin Rezos, chief executive officer of pSivida, anticipates Medidur will provide patients with DME a safe, effective, and long-lasting therapeutic treatment that can be provided non-surgically by eye-care professionals in their offices.