Regeneron Pharmaceuticals has announced positive results from its phase 3 QUASAR trial evaluating Eylea HD (aflibercept 8 mg) injection for macular edema following retinal vein occlusion (RVO). The data, presented at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2025 meeting, indicate that Eylea HD, when dosed every 8 weeks, achieved noninferior vision gains compared to the standard-of-care aflibercept 2 mg injection given every 4 weeks.

In the trial, 88% of the 591 patients treated with Eylea HD sustained an 8-week dosing regimen after 3 initial monthly doses, while 93% maintained the interval after 5 monthly doses. The treatment was generally well tolerated, with a safety profile similar to the original Eylea formulation.

“Current treatment requires monthly injections, which can be challenging for patients to maintain,” said Seenu Hariprasad, MD, chair of the department of ophthalmology and visual science at the University of Chicago, in a press release. “These results suggest Eylea HD may reduce the treatment burden while maintaining efficacy.”

Regeneron reported that it plans to submit a supplemental biologics license application (BLA) to the US Food and Drug Administration in early 2025. RP