ATLANTA The Food and Drug Administration has granted priority review for a diabetic macular edema treatment.
Alimera Sciences said Monday that the priority review of Iluvien (fluocinolone acetonide intravitreal insert) will speed up the review time from 10 months to six months. Alimera currently is conducting two phase-3 pivotal clinical trials -- collectively known as the FAME Study -- for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien with two doses, a high and low dose, for the treatment of diabetic macular edema, the primary cause of vision loss associated with diabetic retinopathy.
"Receiving priority-review status from the FDA marks another important milestone in our efforts to provide an approved therapeutic option to diabetic macular edema patients," said Dan Myers, president and CEO of Alimera Sciences. "If approved, we believe that Iluvien will be the first pharmaceutical in the United States indicated to treat this disease, and the first long-term treatment with the potential to be therapeutically effective for up to 36 months."