Iluvien Implant Gains FDA Approval for DME

Alimera Sciences announced that the Food and Drug Administration (FDA) has approved Iluvien (fluocinolone acetonide intravitreal implant) 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).

Iluvien implant is designed to release fluocinolone acetonide at submicrogram levels for 36 months. The approval was based on clinical data that showed 28.7% of patients treated with Iluvien (P<0.002) experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart of ≥15 letters at Month 24. These patients experienced a statistically significant improvement in visual acuity vs. the control group by Week 3 of follow-up, and sustained a statistically significant advantage compared to the control group by Month 36.

RELATED: Iluvien’s NDA Resubmitted to FDA for Chronic Diabetic Macular Edema

Iluvien contains a corticosteroid that inhibits inflammatory responses to a variety of inciting agents. Corticosteroids act by inhibition of phospholipase A2 via induction of inhibitory proteins collectively called lipocortins. Lipocortins control biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting release of the common precursor, arachidonic acid.

Iluvien will be available as a 0.19mg sustained-release intravitreal implant in a single-use preloaded applicator. It is expected to be available in the 1st quarter of 2015.

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