Regeneron Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved extended dosing intervals for Eylea HD (aflibercept 8 mg) in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). The new label allows treatment as infrequently as every 20 weeks for patients who have responded successfully for a year, based on visual and anatomic outcomes.

The approval incorporates 96-week data from 2 pivotal trials, PULSAR (nAMD) and PHOTON (DME). Among patients completing week 96, 71% of nAMD and 72% of DME patients reached last-assigned dosing intervals of ≥16 weeks, while 47% and 44%, respectively, reached intervals of ≥20 weeks. Visual and anatomic improvements were maintained, and safety profiles remained consistent with prior data. The most common adverse events reported were cataract, conjunctival hemorrhage, increased intraocular pressure, blurred vision, and vitreous floaters.

The 20-week interval with Eylea HD represents the longest FDA-approved dosing interval for any injectable anti-VEGF, potentially reducing treatment burden for patients.

Regeneron also reported that a prefilled Eylea HD syringe formulation is also under FDA review, with a target action date scheduled later this month. RP