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news.Alimera Sciences has received approval from the US Food and Drug Administration (FDA) for ILUVIEN (fluocinolone acetonide intravitreal implant) to treat diabetic macular edema (DME).
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ILUVIEN 0.19mg is a sustained release intravitreal implant approved in the US for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).
Currently, the company intends to start selling ILUVIEN in the US in the first quarter of 2015.
The company said that each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
ILUVIEN is injected in the back of the patient’s eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound.
In the Phase III clinical trial of ILUVIEN (FAME Study) the most frequently reported adverse drug reactions were cataract development and increased ocular pressure.