The FDA today approved Iluvien (fluocinolone acetonide intravitreal implant) for treatment of diabetic macular edema, according to a press release from Alimera Sciences.
Specifically, the agency granted approval for treatment of diabetic macular edema in patients who previously received treatment with corticosteroids and did not experience a clinically significant rise in intraocular pressure.
Alimera stated in the release that they expect Iluvien to be available in the United States in the first quarter of 2015.
Iluvien 0.19 mg is a sustained-release intravitreal implant that is injected in the back of a patient’s eye with an applicator with a 25-gauge needle.
The most frequently reported adverse drug interactions were cataract development increased ocular pressure in the phase 3 FAME study.