Pune, India | November 20, 2025
Regeneron announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg for multiple serious retinal conditions. This higher-dose formulation now treats macular edema caused by retinal vein occlusion (RVO) and allows monthly dosing for other approved retinal disease indications. Consequently, physicians gain greater flexibility when designing patient-specific treatment plans.
EYLEA HD becomes the first therapy for RVO offering up to eight-week dosing after an initial monthly loading phase. Simultaneously, the FDA approved a four-week dosing option for patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO. Therefore, clinicians can tailor treatment schedules based on disease severity, patient tolerance, and lifestyle considerations.
Regeneron’s Chief Scientific Officer, Dr. George D. Yancopoulos, applauded the approval and emphasized the company’s dedication to retinal disease patients. He noted that the approval provides physicians with more tools to personalize therapy effectively, ultimately improving visual outcomes. Moreover, Dr. Yancopoulos stressed that enhanced flexibility in dosing could reduce treatment burden for patients requiring frequent injections.
The FDA granted approval based primarily on Phase 3 QUASAR trial data. This study compared EYLEA HD (8 mg) administered every eight weeks, following either three or five monthly doses, with standard EYLEA (2 mg) given every four weeks. The trial successfully met its primary endpoint at 36 weeks. Patients receiving EYLEA HD achieved visual acuity improvements equivalent to those receiving the standard 2 mg dose.
Safety outcomes from the QUASAR trial revealed that adverse events with EYLEA HD closely matched those seen with standard EYLEA. Elevated intraocular pressure occurred in approximately 5% of EYLEA HD patients, whereas only 1.7% of standard EYLEA patients experienced this side effect. One case each of endophthalmitis and retinal vasculitis appeared in the EYLEA HD group, compared to two endophthalmitis cases and no retinal vasculitis cases in the standard group. Importantly, no cases of occlusive retinal vasculitis occurred in the high-dose cohort.
This regulatory milestone follows prior successes in other pivotal trials. Specifically, the PULSAR (wAMD) and PHOTON (DME) studies demonstrated that EYLEA HD, when administered every 12 or 16 weeks after three initial monthly injections, delivered vision gains comparable to standard EYLEA therapy at 48 weeks. Therefore, clinicians can consider longer dosing intervals without sacrificing efficacy.
Regeneron develops EYLEA HD in collaboration with Bayer AG. While Regeneron holds exclusive marketing rights in the U.S., Bayer manages distribution outside the country, and the companies share profits equally. This partnership enables broader access to patients worldwide while maintaining consistent product quality.
However, not all regulatory objectives were achieved. Earlier this year, the FDA issued a complete response letter (CRL), rejecting Regeneron’s request to extend dosing intervals beyond 16 weeks. The agency cited manufacturing and regulatory concerns rather than safety or efficacy issues. Regeneron is currently reviewing strategies to address the feedback and pursue potential label expansion in the future.
Regeneron manufactures EYLEA HD in the U.S. using a vial format. Approved dosing intervals range from eight to 16 weeks, depending on the patient’s disease type and treatment response. Consequently, patients with RVO, including central, branch, and hemiretinal vein occlusions, may benefit from fewer injections while maintaining visual improvement.
RVO remains a leading cause of vision loss, affecting more than 28 million people globally. The newly approved eight-week dosing regimen may significantly reduce the injection burden, improve adherence, and enhance quality of life for patients. In addition, patients receiving EYLEA HD can potentially experience fewer clinic visits, lowering overall treatment-related stress.
Regeneron also promotes patient access through its EYLEA 4U program, which provides insurance navigation and financial support for eligible individuals. This initiative ensures that cost barriers do not prevent patients from receiving timely and effective treatment. Therefore, both clinicians and patients benefit from improved accessibility and affordability.
With FDA approval finalized, EYLEA HD’s expanded label strengthens its role in managing retinal diseases. The therapy now allows more patients to maintain vision while reducing injection frequency. As a result, physicians can better tailor treatments, and patients may enjoy improved comfort and convenience. Clinicians and patients alike are expected to welcome this regulatory milestone, which reflects ongoing progress in retinal disease management.
