Pune, India | November 20, 2025
The U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg, marking a significant advancement in retinal disease management. Accordingly, Regeneron reports that this high-dose therapy effectively treats macular edema caused by retinal vein occlusion (RVO). As well as wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Moreover, the approval allows monthly dosing for these conditions. It also introduces the first RVO treatment with up to eight-week intervals after an initial monthly loading period. As a result, therapy is simpler for patients.
Physicians now have greater flexibility in designing treatment schedules. Specifically, EYLEA HD offers a monthly dosing option for wAMD, DME, DR, and RVO. This flexibility allows doctors to adjust therapy based on disease progression and patient needs. Furthermore, Dr. George D. Yancopoulos, Regeneron’s Chief Scientific Officer, praised the FDA’s decision, noting that clinicians can now personalize therapy more effectively, which may improve adherence and outcomes.
The FDA’s approval relied on the Phase 3 QUASAR trial. The study compared EYLEA HD (8 mg) every eight weeks, after three or five monthly injections, to standard EYLEA (2 mg) given every four weeks. By 36 weeks, patients on EYLEA HD achieved visual acuity gains equivalent to those receiving the standard dose, demonstrating the effectiveness of extended intervals. Additionally, safety results showed similar adverse event rates for both groups. About 5% of EYLEA HD recipients experienced elevated intraocular pressure, compared to 1.7% for standard EYLEA. The high-dose group reported one case each of endophthalmitis and retinal vasculitis, while the standard group had two cases of endophthalmitis and no vasculitis. Importantly, no occlusive retinal vasculitis occurred in the high-dose group, supporting a strong safety profile.
This FDA approval builds on previous clinical studies. The PULSAR (wAMD) and PHOTON (DME) trials showed that EYLEA HD, administered every 12 or 16 weeks after monthly loading, maintained vision gains for 48 weeks, similar to standard EYLEA. Consequently, EYLEA HD reduces injection frequency while maintaining effectiveness, benefiting both patients and doctors.
Regeneron developed EYLEA HD in collaboration with Bayer AG. Regeneron holds exclusive U.S. marketing rights, while Bayer manages markets outside the U.S., with profits shared equally. However, not all regulatory goals were met. Earlier this year, the FDA issued a complete response letter (CRL), denying requests to extend dosing beyond 16 weeks due to manufacturing and regulatory concerns. Currently, Regeneron is reviewing how to address the FDA’s feedback to pursue further dosing flexibility.
EYLEA HD is available in vial format from Regeneron in the U.S. Approved dosing intervals are every 8 to 16 weeks, after patients complete the initial monthly loading injections. Individuals with RVO, including central, branch, and hemiretinal vein occlusion, may require fewer injections, therefore easing treatment burden. RVO remains a leading cause of vision loss, affecting over 28 million people worldwide.
In addition, Regeneron supports patients through the EYLEA 4U program, which helps with insurance coverage and provides financial resources for eligible patients. FDA approval of EYLEA HD expands its label and strengthens its role in retinal disease management. Overall, reduced injection frequency offers clinicians and patients a promising new standard of care, improving quality of life while protecting vision.
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