Industry News — Clinical Updates

FDA Approves Iluvien Implant for Diabetic Macular Edema

The US Food and Drug Administration (FDA) has approved Iluvien (sustained-release fluocinolone acetonide implant; Alimera Sciences, Inc, Alpharetta, GA) for the treatment of diabetic macular edema (DME) in patients previously treated with a course of corticosteroids and who did not have a clinically significant rise in intraocular pressure (IOP). The FDA approved Iluvien without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

Iluvien 0.19 mg is a sustained-release intravitreal implant designed to release submicrogram levels of fluocinolone acetonide for 36 months. The FDA based its approval of Iluvien on clinical trial data that showed that at month 24 after receiving the implant, 28.7% of patients (P = .002) experienced an improvement from baseline in best-corrected visual acuity (BCVA) on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart ≥ 15 letters. Iluvien patients experienced a statistically significant improvement in visual acuity compared to the control group by week 3 of follow-up and maintained a statistically significant advantage over the control through completion of the trial at month 36.

Alimera plans to begin selling Iluvien in the United States during the first quarter of 2015.

September 29, 2014