FDAnews Device Daily Bulletin

BOARD RECOMMENDS CONTINUATION OF MEDIDUR TRIAL

March 21, 2006
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Following a planned interim review, an independent data safety monitoring board (DSMB) has recommended the continuation of the Phase III clinical trial of Medidur, Alimera Sciences, an ophthalmic pharmaceutical company, and pSivida, a bionanotech company, have announced. Medidur, a tiny injectable device, 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 (DME).

After reviewing the preliminary safety data from the initial U. S. patients enrolled in the trial, the DSMB agreed that enrollment should accelerate in the Phase III trial under the current protocol.

DME, a common complication of diabetic retinopathy, is the leading cause of vision loss in people under the age of 65 in the U.S., where it affects an estimated 500,000 people. It is caused by a fluid buildup in the central vision portion of the retina. At present, the only approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots.