Regeneron announced that the FDA has approved Eylea (aflibercept) injection for the treatment of diabetic macular edema (DME).

The FDA approval was based on the 1-year data from the VISTA-DME and VIVID-DME Phase 3 studies (n=862). The studies compared Eylea 2mg once monthly, twice monthly (after 5 initial monthly injections), or macular laser photocoagulation (at baseline and as needed). Th mean changes in Best Corrected Visual Acuity were statistically significantly improved in the Eylea treatment groups compared to the control group. Both Eylea treatment groups gained the ability to read approximately 2 additional lines on an eye chart compared to almost no change in the control group.

RELATED: Eylea Efficacious in Diabetic Macular Edema Trial

In 2011, Eylea was approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), and for the treatment of macular edema following central retinal vein occlusion (CRVO) in 2012.

Eylea is available as a single, 2mg strength intravitreal injection.

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