Regeneron has won two US Food and Drug Administration (FDA) approvals for Eylea HD (aflibercept), adding another indication to its label and offering a more convenient dosing option, as the drugmaker looks to stave off Roche’s rival product and biosimilar pressures.
The FDA has authorised the vascular endothelial growth factor (VEGF) inhibitor for the treatment of patients with macular oedema following retinal vein occlusion (RVO), proving a dosing schedule of up to every eight-weeks following an initial monthly dosing period.
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This marks the fourth approval for the high-dose version of Eylea, with it already indicated for the treatment of wet age-related macular degeneration (wAMD), diabetic macular oedema (DME), and diabetic retinopathy (DR).
The latest approval was based on data from the Phase III QUASAR trial (NCT05850520). This demonstrated Eylea HD’s non-inferiority to Eylea in achieving visual acuity gains in patients with RVO, a condition where a blood clot blocks a retinal vein. The condition leads to blurred or lost vision.
In a further boost to Eylea HD’s outlook, the FDA also approved a monthly dosing option for some patients across the approved indications. While the injection has dosing intervals either every eight, 12, or 16 weeks, depending on the indication, patients who do not maintain a response at extended intervals could benefit from resuming every four-week dosing.
Regeneron’s chief scientific officer George Yancopoulos said: ” Eylea HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies.
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By GlobalData“And with the addition of a monthly dosing option for all four approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”
A “positive catalyst” for Eylea HD’s growth
Eylea HD, the high-dose version of Eylea, is a major growth driver for Regeneron. Sales for both versions of Eylea totalled $1.1bn in the US in Q3 2025, up 28% from Q3 2024. Regeneron has US rights to the drug while Bayer commercialises it elsewhere.
Regeneron has been trying to shift its patient base to Eylea HD, which allows longer intervals between injections. The Eylea franchise is Regeneron’s best-selling product after Dupixent (dupilumab).
Eylea HD sales are forecast to reach $2.74bn by 2031, according to GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
The move to increase Eylea HD uptake comes as Regeneron’s position in the eye disease market has been significantly eroded by Roche’s rival drug Vabysmo (faricimab). Multiple Eylea biosimilars have also flooded the US market amid patent exclusivity loss, which has exerted further pressure on the brand.
In a research note, Citi analysts said the latest approvals are a “positive catalyst for the Eylea franchise, enabling it to more effectively contend with Roche’s Vabysmo in the competitive anti-VEGF market”.
The FDA approvals mark the end of a difficult year for the franchise in the regulatory arena. Decisions by the agency were delayed by issues found at a Novo Nordisk-owned manufacturing site that Regeneron uses for filling vials of Eylea. Novo acquired the Indiana plant as part of its $16.5bn acquisition of CDMO Catalent in December 2024.
The plant’s shortcomings are still dashing approval hopes for a pre-filled syringe version of Eylea HD. The FDA rejected this formulation of the drug in October 2025. Pre-filled syringes would further bolster the franchise with more efficient administration.
Regeneron said it “continues to coordinate with Catalent Indiana (part of Novo Nordisk) as it works to resolve the outstanding issues identified from a July 2025 FDA general site inspection”.
Citi analysts added: “While pre-filled syringe approval is still pending, the immediate impact of the RVO and monthly dosing approvals could drive an inflection in Eylea-HD’s performance as early as Q1 2026, helping counteract prevailing headwinds.”
