Alimera Sciences, Inc., a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that the US Food and Drug Administration (FDA) has approved Iluvien for the treatment of diabetic macular edema (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). Alimera currently intends to begin selling Iluvien in the U.S. in the first quarter of 2015.
"We are very excited by the broader label Iluvien has been granted by the FDA," said Dan Myers, president and chief executive officer of Alimera. "We plan to issue a more detailed announcement on Monday morning."
Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the US to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each Iluvien implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
Corticosteroids have a history of effective use in treating ocular disease inflammation. 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 FAME study, a phase 3 clinical study of Iluvien, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.