FDA Accepts Aflibercept 8 mg for Priority Review to Treat Retinal Vein Occlusion

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept 8 mg (EYLEA HD) for the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in approved indications.1

Announced on April 17, 2025, by Regeneron, the FDA target action date is August 19, 2025, following the use of a Priority Review voucher. An FDA approval would establish aflibercept 8 mg as the first and only RVO treatment eligible for up to every 8-week dosing after an initial monthly period. This would halve the number of injections necessitated by all other anti-vascular endothelial growth factor (anti-VEGF) treatments.1

“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” said Seenu Hariprasad, MD, Chair of the Department of Ophthalmology and Visual Science, University of Chicago, in a previous statement. “Based on [data from the QUASAR trial], aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies.”2

The sBLA is supported by data from across the aflibercept clinical program, including the Phase 3 QUASAR trial, which investigated aflibercept 8 mg in treating RVO. QUASAR was a global double-masked, active-controlled Phase 3 trial, including patients with retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion. Participants were randomized into 3 groups, receiving one of the following dosage patterns:

• Aflibercept 8 mg every 8 weeks following 3 initial monthly doses
• Aflibercept 8 mg every 8 weeks following 5 initial monthly doses
• Aflibercept 2 mg every 4 weeks2

Patients could have dosing intervals shortened to a minimum of every 4 weeks during the trial if certain criteria were met. Intervals could also be extended based on the same criteria starting at week 32 for those who received aflibercept 2 mg or aflibercept 8 mg after 3 monthly doses, or at week 40 for those who received aflibercept 8 mg after 5 monthly doses. Follow-up was planned through week 64.2

As reported in February 2025, QUASAR met its primary endpoint after 36 weeks: both patient groups dosed every 8 weeks achieved non-inferior visual acuity gains compared to those receiving aflibercept 2 mg dosed every 4 weeks. These results were consistent across patients with branch RVO and central retinal or hemiretinal vein occlusions.1

The safety profile for aflibercept 8 mg (n = 591) was similar to aflibercept 2 mg (n = 301) and remained consistent with the higher dosage’s known safety profile from prior trials. Ocular treatment-emergent adverse effects occurred in ≥5% of all patients receiving aflibercept 8 mg; these included increased ocular pressure (5%) and one case each of retinal vasculitis and endophthalmitis. Intraocular inflammation occurred at a rate of 0.5% for aflibercept 8 mg and 1.3% for the 2 mg dosage.2

Regeneron is also seeking regulatory approval to broaden the dosing schedule to include every 4-week (monthly) dosing for all approved indications, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The company noted this would offer greater dosing flexibility for physicians and patients.1

References

1. Regeneron. EYLEA HD (aflibercept) injection 8 mg sBLA accepted for FDA priority review for both the treatment of macular edema following retinal vein occlusion (ROV) and for monthly dosing in approved indications. Regeneron. April 17, 2025. Accessed April 17, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-sbla-accepted-fda-priority

2. Regeneron. EYLEA HD (aflibercept) injection 8 mg positive phase 3 results in patients with macular edema following retinal vein occlusion presented at angiogenesis meeting. Regeneron. February 8, 2025. Accessed April 17, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-positive-phase-3-results