ILUVIEN® for Diabetic Macular Edema (DME)
ILUVIEN® has received its marketing authorization approval in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom. Alimera has received a positive outcome of the Repeat-Use Procedure for ILUVIEN® for the treatment of chronic diabetic macular edema (DME) in an additional 8 European Union countries.
The regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Finland, Poland and the Czech Republic, will now enter the national phase in which each country grants marketing authorization. Alimera Sciences is still seeking approval in the United States. The proposed treatment consists of a tiny, cylindrical polymide tube that contains 190 µg of fluocinolone acetonide (FAc), a corticosteroid. Corticosteroids have a history of treating ocular diseases. Learn More
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.