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The Food and Drug Administration (FDA) has approved Eylea (aflibercept; Regeneron) for the treatment of diabetic retinopathy.
The approval of Eylea, a vascular endothelial growth factor (VEGF) inhibitor, was based on data from the PANORAMA study which included 402 patients with nonproliferative diabetic retinopathy.
Patients in the study were randomized to 1 of 3 dosing regimens: 3 initial monthly Eylea 2mg injections followed by 1 injection after 8 weeks and then 1 injection every 16 weeks (Eylea 2Q16); 2) 5 monthly Eylea 2mg injections followed by 1 injection every 8 weeks (Eylea 2Q8); and 3) sham treatment. The primary efficacy endpoint was the proportion of patients who improved by ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline to week 24 in the combined Eylea groups and at week 52 in the 2Q16 and 2Q8 groups individually vs sham.
Results showed that at Week 24, 58% of patients treated with Eylea had a ≥2-step improvement on DRSS from baseline vs 6% of the sham group. In addition, at Week 52, efficacy in the 2Q16 and 2Q8 groups was found to be superior to the sham group (proportion of patients with a ≥2-step improvement on DRSS from baseline: 65% with 2Q16, 80% with 2Q8, 15% with sham).
“The Panorama trial showed that by 1 year 20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every 16-week or 8-week dosing regimen, respectively,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. “In fact, 80% of patients who received the Eylea 8-week dosing regimen had significant improvement in their diabetic retinopathy.” Safety data observed through week 52 in the Panorama trial were found to be consistent with previous studies of Eylea.
In addition to the diabetic retinopathy indication, Eylea is approved to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema.
Eylea is supplied as a 2mg/0.05mL solution for intravitreal injection in a single-dose vial.
For more information visit eylea.us.
