Regeneron Pharmaceuticals announced that Eylea HD (aflibercept) Injection 8 mg met its primary endpoint in the Phase 3 QUASAR trial for the treatment of macular edema following retinal vein occlusion (RVO), including central, branch and hemiretinal vein occlusions.

Patients treated with Eylea HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of Eylea (aflibercept) Injection 2 mg (the current standard of care), according to a company press release.

The safety profile of Eylea HD (n=591) was similar to Eylea (n=301) and remained generally consistent with the known safety profile of Eylea HD in its pivotal trials. Ocular treatment emergent adverse events occurring in ≥5% of all Eylea HD patients included increased ocular pressure (5%), and one case each of endophthalmitis and retinal vasculitis.

QUASAR is a global, double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of Eylea HD, compared to Eylea, in patients with RVO. Eylea HD patients were treated with an 8-week dosing regimen (after 3 or 5 initial monthly doses), and EYLEA patients were treated every 4 weeks. The primary endpoint was met at 36 weeks, with both groups of Eylea HD patients achieving non-inferior visual acuity gains compared to those receiving Eylea. Eylea HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. The company plans to submit the data in a supplementary biologics license application to the FDA in the first quarter of 2025.

“All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient. These impressive data from QUASAR demonstrated that Eylea HD patients with retinal vein occlusion experienced improved vision with fewer injections than Eylea — which could offer a significant advancement in this treatment setting,” said Seenu M. Hariprasad, MD, Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Furthermore, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks.”

Regeneron is developing Eylea HD (known as Eylea 8 mg in the European Union and Japan) jointly developed with Bayer AG. In the United States, Regeneron maintains exclusive rights to Eylea and Eylea HD. 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.