Regeneron Pharmaceuticals, Inc. announced promising results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for treating macular edema in patients with retinal vein occlusion (RVO). The results were presented during the Angiogenesis 2025 annual meeting, marking a significant advancement in addressing the treatment challenges faced by RVO patients.
Retinal vein occlusion, the second most common retinal vascular disease, often requires frequent monthly injections, making adherence to the treatment schedule difficult for many patients. EYLEA HD offers the potential to reduce the number of injections needed, allowing for an 8-week dosing interval compared to the standard 4-week interval with EYLEA® (aflibercept) 2 mg.
“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Based on these new data, aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies.”
The trial met its primary endpoint at 36 weeks, demonstrating that EYLEA HD dosed every 8 weeks achieved non-inferior visual acuity improvements compared to EYLEA 2 mg dosed every 4 weeks. Additionally, 88% of patients sustained an 8-week dosing regimen after three initial monthly doses, while 93% maintained the schedule after five monthly doses.
The safety profile of EYLEA HD was consistent with previous trials, with ocular treatment-emergent adverse events occurring in 5% or more of patients, including increased ocular pressure. No major safety concerns were identified.
About the QUASAR Trial and Retinal Vein Occlusion (RVO)
The QUASAR trial is a global, double-masked, active-controlled Phase 3 study evaluating the safety and efficacy of EYLEA HD in patients with macular edema secondary to retinal vein occlusion, including central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), and hemiretinal vein occlusion.
Patients were divided into three groups, receiving either EYLEA HD every 8 weeks (after 3 or 5 initial monthly doses) or EYLEA every 4 weeks. The trial’s primary endpoint was the mean change in Best-Corrected Visual Acuity (BCVA) through 36 weeks.
Retinal vein occlusion affects over 28 million people globally. It causes a blockage in the veins of the retina, leading to vision loss and complications such as macular edema. Anti-VEGF therapies, such as EYLEA, remain a cornerstone of treatment, helping to prevent vision deterioration.
EYLEA HD is a collaborative development between Regeneron and Bayer AG. Regeneron holds exclusive rights in the U.S., while Bayer markets the product outside the U.S.
The promising results from the QUASAR trial will support Regeneron’s submission of a supplemental Biologics License Application to the U.S. FDA in the first quarter of 2025. This advancement may significantly improve the quality of life for patients with macular edema secondary to RVO.
