FDA approves Eylea for diabetic retinopathy in patients with diabetic macular edema

25 March 2015

The US Food and Drug Administration today expanded the approved use for US biotech firm Regeneron’s (Nasdaq: REGN) Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema (DME).

In 2014, the FDA granted Eylea Breakthrough Therapy designation and Priority Review for the treatment of diabetic retinopathy in patients with DME. In February this year, the FDA approved Roche subsidiary Genentech’s Lucentis (ranibizumab injection) to treat DR in patients with DME.

Eylea is now approved for four vision-related conditions, including wet Age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy in patients with DME.

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