Fluocinolone Acetonide Intravitreal Implant 0.19 mg (ILUVIEN®): A Review in Diabetic Macular Edema

Abstract

Fluocinolone acetonide intravitreal implant 0.19 mg (ILUVIEN^®) is a nonbiodegradable, injectable, corticosteroid implant that is approved in several countries, including the USA, for the treatment of diabetic macular edema (DME). ILUVIEN^® releases fluocinolone acetonide at an initial rate of 0.25 µg/day (average rate 0.2 µg/day) and lasts 36 months. In the two pooled pivotal FAME trials in patients with DME previously treated with macular laser photocoagulation, fluocinolone acetonide intravitreal implant 0.2 µg/day was significantly more effective than sham injection with respect to the proportion of patients with an improvement from baseline in best-corrected visual acuity of ≥15 letters at 24 months (primary endpoint). This therapeutic effect was maintained at 36 months. The implant also significantly decreased foveal thickness at 24 months. FAME study results are broadly supported by real-world studies in patients with chronic DME considered insufficiently responsive to available therapies. Consistent with corticosteroid class-specific adverse events, cataract and elevated intraocular pressure (IOP) were the most common adverse events with the fluocinolone acetonide intravitreal implant. Raised IOP was treated with medications in most patients, with <5% requiring incisional IOP-lowering surgery. In the USA, fluocinolone acetonide intravitreal implant should be used only in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant increase in IOP. Available data indicate that fluocinolone acetonide intravitreal implant 0.19 mg is a useful option for the treatment of DME in these patients.