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FDA approves EYLEA HD for up to 5-month dosing intervals in treating wAMD and DME

Market News
02 Apr 2026
GlobeNewsWire
View Source
Bullish
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The FDA has approved Regeneron's EYLEA HD (aflibercept) for extended dosing intervals up to 20 weeks (about 5 months) for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) after one year of successful treatment. This approval is based on 96-week data from pivotal PULSAR and PHOTON trials showing sustained visual and anatomical improvements with fewer injections. The extended dosing schedule reduces treatment frequency to 2-3 times a year for many patients, easing treatment burden while maintaining safety and efficacy. This marks the widest range of dosing intervals for any approved injectable anti-VEGF therapy, allowing personalized treatment plans.

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