Positive Phase 3 Results for EYLEA HD® in Macular Edema Post-Retinal Vein Occlusion Presented

Regeneron Pharmaceuticals, based in Tarrytown, New York, recently revealed promising findings from its Phase 3 QUASAR trial, which evaluated the efficacy of EYLEA HD® (aflibercept) Injection 8 mg for treating macular edema following retinal vein occlusion (RVO). This condition affects a significant number of individuals and is the second most common retinal vascular disease. The results were shared at the Angiogenesis 2025 annual meeting and are expected to lead to a supplemental Biologics License Application submission to the U.S. Food and Drug Administration in early 2025.

Dr. Seenu M. Hariprasad, a leading ophthalmology expert from The University of Chicago, emphasized the challenges patients face with the current treatment regimen of monthly eye injections. This schedule can hinder adherence, potentially causing vision impairment. The new data suggests that aflibercept 8 mg might reduce the frequency of injections needed, offering a significant advantage over the existing standard treatment of aflibercept 2 mg and other anti-VEGF therapies.

The QUASAR trial successfully reached its primary goal at 36 weeks. Patients receiving EYLEA HD every eight weeks showed comparable improvements in visual acuity to those receiving EYLEA 2 mg every four weeks. The outcomes were consistent among patients with various types of retinal vein occlusions, including branch, central, and hemiretinal. Notably, 88% of patients on EYLEA HD maintained an eight-week dosing schedule after three initial monthly doses, while 93% continued the regimen following five initial monthly doses.

Safety outcomes from the trial revealed that the safety profile of EYLEA HD (tested on 591 participants) was similar to that of EYLEA (tested on 301 participants). Common ocular treatment-emergent adverse events included increased ocular pressure in 5% of patients, with rare occurrences of endophthalmitis and retinal vasculitis. The incidence of intraocular inflammation was 0.5% for EYLEA HD compared to 1.3% for EYLEA.

EYLEA HD, also known as Eylea™ 8 mg in the European Union and Japan, is developed in collaboration with Bayer AG. Regeneron holds exclusive rights to EYLEA and EYLEA HD in the United States, while Bayer manages exclusive marketing rights outside the U.S., with both companies sharing profits from global sales equally.

The QUASAR trial is a double-masked, active-controlled Phase 3 study assessing the effectiveness and safety of EYLEA HD in treating macular edema due to RVO. Participants were divided into groups, receiving varied dosing schedules of EYLEA HD or EYLEA. The study's primary focus was the change in best-corrected visual acuity (BCVA) from the start through week 36. Dosing intervals could be adjusted based on disease progression and could extend beyond the designated weeks, with follow-up planned through week 64. Bayer oversees the trial operations under a partnership with Regeneron.

Retinal vein occlusion, a significant cause of vision loss, arises from a blockage in the retina's veins, leading to blood buildup, restricted flow, and increased pressure, potentially resulting in blurry vision or vision loss. Macular edema, a swelling in the eye, can develop due to elevated levels of vascular endothelial growth factor (VEGF), which prompts new blood vessel growth. Anti-VEGF injections, including aflibercept, are commonly used to combat this condition. Central and branch retinal vein occlusions are the primary types of RVO, affecting over 28 million people worldwide.

EYLEA HD and EYLEA are administered via injection into the eye and are approved for various conditions, including Wet Age-Related Macular Degeneration and Diabetic Macular Edema. Patients should avoid use if they have eye infections, pain, or allergies to the components. Potential side effects include eye infection, retinal detachment, and inflammation. Patients are advised to report any adverse effects to healthcare providers promptly.