The US Food and Drug Administration (FDA) has approved Eylea HD (aflibercept 8 mg) for macular edema following retinal vein occlusion (RVO), allowing dosing every 8 weeks after an initial monthly series. The agency also authorized monthly (every 4 week) dosing for patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and diabetic retinopathy (DR), as well as RVO patients who need to return to shorter intervals.

“Retinal vein occlusion is the second most common retinal vascular disease, yet the need for monthly injections has long made it difficult for many patients to stay on their treatment schedule, increasing the risk of vision loss,” explained Seenu M. Hariprasad, MD, chair of the department of ophthalmology and visual science at the University of Chicago. “With the FDA’s approval of aflibercept 8 mg for RVO, we now have an option that, based on clinical data, may allow patients to receive injections far less frequently than with aflibercept 2 mg and other anti-VEGF therapies.”

The approval for RVO is based on data from the phase 3 QUASAR trial, which showed that patients treated with Eylea HD every 8 weeks, after 3 or 5 monthly doses, achieved noninferior visual acuity gains at week 36 compared with patients receiving 2 mg aflibercept every 4 weeks. Anatomic improvements tracked closely with visual outcomes, with the aflibercept 8 mg groups achieving robust central retinal thickness reductions compared to 2 mg at week 36, with fewer injections. Results were consistent across central, branch, and hemiretinal vein occlusions.

Eylea HD maintains previously approved extended dosing ranges from every 8 to 16 weeks for wAMD and DME, and every 8 to 12 weeks for DR. RP