Enrollment complete in phase III trial of insert for DME

Atlanta-Enrollment is complete for the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study of a proprietary intravitreal insert with fluocinolone acetonide (Medidur FA) to treat diabetic macular edema (DME), announced Alimera Sciences Inc. and pSivida Ltd. The two companies are jointly developing the vehicle under a collaborative research and development agreement.

“This brings us closer to taking . . . the next generation of retinal drug delivery to market and to our ultimate goal of delivering treatments that enrich patients’ quality of life,” said Dan Myers, chief executive officer of Alimera.

Paul Ashton, PhD, limited managing director of pSivida, said, “We are optimistic that [the insert] will offer a solution to the large market we see for this product.”

The double-masked, randomized, multicenter study will follow more than 900 patients in the United States, Canada, Europe, and India for 3 years. Safety and efficacy will be assessed at 2 years.