Perspective from Charles C. Wykoff, MD, PhD
May 13, 2019
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FDA approves Regeneron’s Eylea for diabetic retinopathy

Perspective from Charles C. Wykoff, MD, PhD
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The FDA has approved Regeneron Pharmaceuticals’ aflibercept injection, Eylea, for the treatment of all stages of diabetic retinopathy.

The approval was based on results of the phase 3 PANORAMA trial, which enrolled 402 patients to investigate Eylea’s effect on the improvement of moderately severe to severe non-proliferative diabetic retinopathy compared with sham injection.

The study included an observational sham injection group and two Eylea treatment groups. After initial monthly dosing protocols, Eylea was dosed every 8 weeks or every 16 weeks, according to a Regeneron press release.

Patients treated more frequently exhibited a greater improvement in diabetic retinopathy severity scale (DRSS) scores from baseline. Eighty percent of patients treated every 8 weeks experienced a two-step or more improvement on DRSS scores from baseline compared with 65% of patients treated very 16 weeks. Only 15% of sham control patients experienced a two-step improvement.

Additionally, 4% of patients treated every 16 weeks and 2% of patients treated every 8 weeks progressed to proliferative diabetic retinopathy or anterior segment neovascularization, compared with 20% in the sham control. The event rate for proliferative diabetic retinopathy alone was 2% in the every-16-week group, 0% in the every-8-week group and 12% in the sham control group.

Eylea is the only VEGF inhibitor approved with two dosing options for diabetic retinopathy, according to the press release.