Positive Results for Eylea in Diabetic Macular Edema

Regeneron and Bayer HealthCare announced results from the Phase 3 VIVID-DME and VISTA-DME trials of Eylea (aflibercept) Injection for the treatment of diabetic macular edema (DME). Eylea is a recombinant fusion protein, consisting of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1. 

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The VIVID-DME and VISTA-DME trials are randomized, double-masked, active control trials to evaluate the safety and efficacy of Eylea in patients with DME.  Patients in both trials were randomized to receive either Eylea 2mg monthly, Eylea 2mg every two months after 5 initial monthly injections, or the comparator treatment of laser photocoagulation.

Eylea 2mg monthly and Eylea 2mg every two months after 5 initial monthly injections achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.  Both Eylea treatment arms demonstrated similar improvements in BCVA.

After one year, patients receiving Eylea 2mg monthly had a mean change from baseline in BCVA of 10.5 letters (P<0.0001 compared to laser) in the VIVID-DME trial and 12.5 letters (P<0.0001 compared to laser) in the VISTA-DME trial. In the VIVID-DME trial, patients receiving Eylea 2mg every other month after 5 initial monthly injections had a mean change from baseline in BCVA of 10.7 letters (P<0.0001 compared to laser), compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of 1.2 letters. In the VISTA-DME trial, patients receiving Eylea 2mg every other month after 5 initial monthly injections had a mean change from baseline in BCVA of 10.7 letters (P<0.0001 compared to laser), compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of 0.2 letters.

Eylea is already approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and for macular edema following central retinal vein occlusion (CRVO).

For more information visit Regeneron.com or Bayer.com.