First long-term treatment for DME approved by FDA

September 30, 2014

FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

“Iluvien is an interesting drug for the treatment of diabetic macular edema,” said FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, University of Missouri-Kansas City School of Medicine. “Diabetes-induced ocular disease is quite common. It remains to be seen how effective this drug will be at preventing vision issues in patients. The best treatment is still tight management of diabetes which will prevent the problem from ever occurring.”

The drug maker had previously resubmitted a New Drug Application for the treatment to FDA in April, which provided a safety update-including commercial experience with the product in Europe-and responded to questions raised in an October 2013 complete response letter from the governmental agency. 

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

Each Iluvien implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.

The drug’s approval was based on clinical trial data that showed that at month 24 after receiving the Iluvien implant, 28.7% of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. Patients treated with Iluvien 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.