Eylea HD meets primary endpoint of improved vision in phase 3 retinal vein occlusion trial

Eylea HD improved vision with extended dosing intervals in patients with macular edema following retinal vein occlusion in the phase 3 QUASAR trial, according to a press release from Regeneron.

Patients underwent treatment with Eylea HD (aflibercept 8 mg) every 8 weeks after three (293 patients) or five (298 patients) initial monthly doses, while a control group underwent treatment with Eylea 2 mg every 4 weeks (301 patients). The study met its primary endpoint at 36 weeks, with both Eylea HD groups achieving noninferior visual acuity gains compared with the Eylea 2 mg group, according to the release.

Eylea HD had a similar safety profile to Eylea 2 mg in the study and was consistent with the known safety profile in its pivotal trials.

Regeneron plans to submit a supplementary biologics license application to the FDA for this indication in the first quarter of 2025, according to the release.

“Eylea HD has already made a significant impact on the treatment of its three approved indications — wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy — and now has the potential to substantially reduce the treatment burden for patients with retinal vein occlusion,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, said in the release. “We look forward to sharing these results with regulatory authorities around the world as soon as possible.”

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