ILUVIEN^® for Diabetic Macular Edema (DME)

ILUVIEN is a proposed treatment for Diabetic Macular Edema (DME) currently under review by the US Food and Drug Administration (FDA) as well as with 7 European health authorities. It consists of a tiny, cylindrical polyimide tube that contains 190 µg of fluocinolone acetonide (FAc), a corticosteroid with a history of treating ocular diseases. ILUVIEN is administered as an intravitreal insert, and it is being studied for its potential to provide a sustained release of a low, steady, daily dose of fluocinolone acetonide over an anticipated 24-to-36-month period. ILUVIEN is designed to be inserted into the patient’s eye in a retinal specialist’s office using an intravitreal injection, a procedure commonly employed by retina specialists.

As such, studying ILUVIEN’s safety and efficacy in Diabetic Macular Edema (DME) treatment has been a primary focus of Alimera Sciences. However, ILUVIEN is also being studied in several clinical trials with retinal specialists to determine its safety and efficacy for other retinal diseases, including Age-Related Macular Degeneration (AMD) (wet and dry) and Retinal Vein Occlusion.

Clinical Studies of ILUVIEN

A global clinical study, known as FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema), consisted of two masked, randomized, multi-center trials that were fully enrolled with 956 patients in the U.S., Canada, Europe and India. FAME is a three-year study. Safety and efficacy at 24 months was the basis for global registration submissions. The pending submissions are being updated with the 36-month safety and efficacy data.

The clinical trials studied two doses of ILUVIEN: a higher dose with an initial release rate of approximately 0.45 micrograms (µg) per day and a lower dose with an initial release rate of approximately 0.23 µg per day. With either dose, ILUVIEN releases the lowest daily amount of drug among products currently undergoing clinical trials for treating DME.