Phase III trial continues for device injected into retina of DME patients

After a planned interim review, an independent Data Safety Monitoring Board (DSMB) recommended that Alimera Sciences Inc. and pSivida Ltd. accelerate enrollment in the phase III trial of a retinal device for patients with diabetic macular edema (DME). This tiny device (Medidur) may deliver fluocinolone acetonide to the retina for up to 3 years.

Even though the DSMB encouraged the study to continue under current protocol, the group identified potential safety issues that might warrant modification or early termination of ongoing studies.

Alimera Sciences’ CEO Dan Myers said this phase of the masked, randomized, multicenter clinical trial will include the United States, Canada, Europe, and India.