The U.S. Food and Drug Administration has approved extended dosing intervals for EYLEA HD (aflibercept), allowing treatment up to every 20 weeks in patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) who have demonstrated a successful response after 1 year, according to a press release.
The decision is based on 96-week data from the pivotal PULSAR and PHOTON trials, which showed that most patients maintained visual and anatomic improvements with longer dosing intervals.
The updated label includes 2-year results demonstrating sustained efficacy and safety with extended dosing. Among patients completing 96 weeks, 71% of those with wAMD and 72% with DME achieved dosing intervals of at least 16 weeks, while 47% and 44%, respectively, reached intervals of at least 20 weeks. Outcomes at 96 weeks remained consistent with those observed at 48 weeks.
The most commonly reported adverse reactions (≥3%) included cataract, conjunctival hemorrhage, corneal epithelium defect, increased intraocular pressure, ocular discomfort, retinal hemorrhage, blurred vision, vitreous detachment, and vitreous floaters.
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