FDA approves Iluvien for DMO - Alimera Sciences

The FDA has approved Iluvien (fluocinolone acetonide), from Alimera Sciences, for the treatment of Diabetic Macular Oedema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Alimera currently intends to begin selling ILUVIEN in the U.S. in the first quarter of 2015.

The application was based on data from the completed 36-month FAME Study which reported that for this subgroup at 36 months in Trial A, 31.8% of patients treated with Iluvien experienced an improvement in best corrected visual acuity (BCVA) of 15 or more letters from baseline compared with 13.6% of those in the control group, for a net benefit of Iluvien versus control of 18.2%. In Trial B, 36.4% of Iluvien patients in this subgroup experienced improvement of 15 or more letters compared to 13.2% of control patients, for a net benefit of Iluvien versus control of 23.2%.

On a combined basis for both Trials A and B, at three years the net benefit of Iluvien compared to control reported for patients in the subgroup was 20.6%, more than double that seen for the full patient population (9.8%).