Regeneron Pharmaceuticals announced the first presentation of positive results from the Phase 3 QUASAR trial investigating Eylea HD (aflibercept) Injection 8 mg for the treatment of macular edema following retinal vein occlusion (RVO), including central, branch and hemiretinal vein occlusions. The data were presented at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual meeting and will support the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) in the first quarter of 2025, the company said in a press release.

The QUASAR trial met its primary endpoint at 36 weeks, with both groups of Eylea HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving Eylea (aflibercept) Injection 2 mg dosed every 4 weeks, Regeneron reported. The Eylea HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Furthermore, in patients treated with Eylea HD through 36 weeks, 88% of patients were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.

According to Regeneron, the safety profile of EYLEA HD (n=591) was similar to Eylea (n=301) in QUASAR and remained generally consistent with the known safety profile of Eylea HD in its pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in ≥5% of all EYLEA HD patients included increased ocular pressure (5%); there was one case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was 0.5% for Eylea HD and 1.3% for Eylea.

Eylea HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to Eylea and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside of the United States, where the companies share equally the profits from sales of Eylea and Eylea HD.