Regeneron Pharmaceuticals has announced that the phase 3 QUASAR trial for Eylea HD (aflibercept 8 mg) met its primary endpoint, showing noninferior vision improvements in patients with macular edema secondary to retinal vein occlusion (RVO), compared to the standard monthly dosing of Eylea (aflibercept 2 mg).

The trial results indicate that Eylea HD, administered every eight weeks after initial monthly doses, achieves comparable best-corrected visual acuity (BCVA) gains while reducing injection frequency. Patients treated with Eylea HD gained 17 to 19 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, similar to the 18-letter improvement in the standard dosing group. Nearly 90% of patients maintained 8-week dosing intervals through 36 weeks. Safety outcomes for Eylea HD were consistent with previous studies, with low rates of ocular inflammation and thromboembolic events.

“All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient,” said Seenu M. Hariprasad, MD, chair of the department of ophthalmology and visual science at the University of Chicago, in a press release. “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.”

The QUASAR study was conducted by Bayer under a collaboration agreement with Regeneron; Bayer has licensed the marketing rights for Elyea and Eylea HD outside of the United States.

Regeneron said in a press release that it intends to submit a supplemental biologics license application to the FDA in early 2025, with global regulatory submissions to follow.