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FDA approves Regeneron’s Eylea for diabetic retinopathy
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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.
Perspective
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Charles C. Wykoff, MD, PhD
The most exciting aspect of this approval is the associated PANORMA phase 3 data set. This is the first prospective trial in the anti-VEGF era to specifically study nonproliferative diabetic retinopathy (NPDR) eyes without diabetic macular edema (DME). The anatomic benefits achieved with aflibercept anti-VEGF dosing were rapid and impressive compared to sham treatment, with both significant improvement in diabetic retinopathy severity levels and significant reduction in the development of clinically relevant endpoints including PDR and DME. Clinicians now have excellent data to guide management decisions for this large population of patients. Overall, I think the decision to intervene must be individualized within the context of each patient and their clinical circumstances. I look forward to additional data from PANORAMA as ultimately this is a 2-year study.
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