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.


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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.