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Eylea Outdoes Avastin and Lucentis in Diabetic Macular Edema Study

Top-line results released in NIH-funded comparison of effectiveness

Aflibercept injection (Eylea, Regeneron Pharmaceuticals, Inc.) aided vision in patients with diabetic macular edema more than bevacizumab (Avastin, Genentech) and ranibizumab injection (Lucentis, Genentech), according to top-line results of a comparative effectiveness study.

Aflibercept demonstrated a significantly greater improvement in mean change in best-corrected visual acuity from baseline at 52 weeks compared with bevacizumab and ranibizumab in the study, sponsored by the National Institutes of Health Diabetic Retinopathy Clinical Research Network (

The median number of injections using the protocol-specified retreatment regimen was one fewer in patients treated with aflibercept compared with the other two medications. Fewer patients in the aflibercept group received criteria-based macular laser treatments than those treated with bevacizumab and ranibizumab. has shared these top-line results with study investigators and is finalizing and verifiying the data prior to submission for publication.

The independent, government-sponsored study was designed to determine if one of the three vascular endothelial growth factor inhibitors is superior to the others for the treatment of diabetic macular edema. In the study, 660 patients were randomized to receive either aflibercept 2 mg, bevacizumab 1.25 mg, or ranibizumab 0.3 mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24-week visit under certain prespecified conditions.

The rates of most ocular and systemic adverse events (AEs) were similar across the three study groups. The rates of arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (nonfatal stroke, nonfatal myocardial infarction, and vascular death) in the trial were 2% in the aflibercept group, 4% in the bevacizumab group, and 5% in the ranibizumab group. There were more overall cardiovascular events in the ranibizumab group, compared to the aflibercept group and the bevacizumab group (nominal P, < 0.01); this included more cardiac events and cerebrovascular events in the ranibizumab group.

In addition to diabetic macular edema, aflibercept injection is approved for the treatment of patients with wet age-related macular degeneration and macular edema following retinal vein occlusion.

Source: Regeneron Pharmaceuticals, Inc.; October 17, 2014.

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