Eylea injection sBLA for every 16-week dosing regimen in patients with diabetic retinopathy accepted for FDA review.- Regeneron.
Regeneron Pharmaceuticals, Inc. announced the FDA as accepted for review the Eylea (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.
DR is the leading cause of blindness among working-age American adults, affecting more than 8 million people in the U.S. alone.
In 2019, Eylea was approved for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after five initial monthly doses. If approved, the 16-week dosing regimen could offer certain patients a potentially longer treatment interval and doctors with greater flexibility to individualize treatment. The sBLA is supported by data from the Phase III PANORAMA trial investigating every 8- and 16-week Eylea dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The submission was further supported by data from the NIH-sponsored Protocol W trial investigating an Eylea every 16-week dosing regimen in patients with moderate to severe NPDR without center-involved DME versus sham.
At 1 year, PANORAMA met its primary endpoint of proportion of patients with greater than 2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score. At 2 years, in both the PANORAMA and Protocol W trials, a greater proportion of patients receiving Eylea every 16-weeks experienced a greater than 2-step improvement in DRSS score, along with greater reductions in the risk of developing vision-threatening complications, versus sham.
The rates of serious ocular adverse events and intraocular inflammation in patients treated with Eylea every 16 weeks were similar across both studies. In addition to DR with a 4- or 8-week dosing regimen, Eylea is approved for the treatment of neovascular (Wet) age-related macular degeneration, macular edema following retinal vein occlusion and DME. The potential use of the 16-week dosing regimen for Eylea in DR has not been fully evaluated by any regulatory authority.
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