Regeneron announced that the Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a new Eylea (aflibercept) dosing schedule in patients with wet age-related macular degeneration (wet AMD).
The approval was supported by year 2 data from the Phase 3 VIEW 1 and VIEW 2 trials that evaluated 2412 patients with wet AMD who followed a modified 12-week dosing schedule (doses at least every 12 weeks and additional doses as needed). Both studies were 96 weeks in duration but after week 52, patients did not follow a fixed dosing schedule. Between weeks 52 and 96, patients continued to receive the drug and dosage strength to which they were initially randomized on the modified 12-week dosing schedule.
The prescribing information has been updated to state, “Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.”
Eylea, a vascular endothelial growth factor (VEGF) inhibitor, is approved to treat macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) in patients with DME. It works by blocking the growth of new blood vessels and decreasing vascular permeability in the eye through VEGF-A and placental growth factor (PLGF) inhibition.
It is supplied as 40mg/mL solution in single-use vials for intravitreal injection.
For more information call (855) 395-3248 or visit Eylea.com.