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Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.
The FDA has accepted for review the Eylea (aflibercept) injection supplemental biologics license application (sBLA) for an every 16-week 2 mg dosing regimen in patients with diabetic retinopathy. The target action date for the FDA decision is Feb. 28, 2023.
Eylea is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor. In 2019, the FDA approved Eylea for the treatment of all stages of diabetic retinopathy with a dosing regimen of every four or eight weeks after five initial monthly doses. Eylea is also approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
The supplemental application is supported by data from the phase 3 PANORAMA trial investigating every 8- and 16-week Eylea dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy without diabetic macular edema. The submission was further supported by data from the NIH-sponsored Protocol W trial investigating Eylea every 16-week dosing regimen in patients with moderate-to-severe non-proliferative diabetic retinopathy without center-involved DME versus sham.
At one year, the PANORAMA trial met its primary endpoint of proportion of patients with ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score. At two years, in both studies, a greater proportion of patients receiving Eylea every 16-weeks experienced a ≥2-step improvement in DRSS score, along with greater reductions in the risk of developing vision-threatening complications. The rates of serious ocular adverse events and intraocular inflammation in treated patients treated were similar across both studies.
Diabetic retinopathy is the leading cause of blindness among working-age American adults, affecting more than 8 million people in the United States alone.