US FDA approves Iluvien for diabetic macular edema
US ophthalmic drug specialist Alimera Sciences (Nasdaq: ALIM) says that the US Food and Drug Administration has approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME). The company’s shares shot up 23% 5o $6.06 in after-hours trading on Friday.
The approval is for use 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 Lin the USA in the first quarter of 2015. A single injection of the Iluvien micro-insert provides sustained treatment of DME for 36 months, according to the company.
Around 560,000 people in the USA are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries.
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