EYLEA HD® 8 mg Trial Achieves Vision Improvement with Extended Dosing in Macular Edema Patients

Regeneron Pharmaceuticals, Inc. has announced that their Phase 3 QUASAR trial has successfully met its primary goal, demonstrating that EYLEA HD® (aflibercept) Injection 8 mg offers non-inferior vision improvements with an every 8-week dosage compared to the typical monthly administration of EYLEA® (aflibercept) Injection 2 mg for patients dealing with macular edema following retinal vein occlusion (RVO). This potentially reduces the frequency of necessary injections, easing the treatment burden for patients. A submission to the U.S. Food and Drug Administration (FDA) is anticipated in the first quarter of 2025.

The trial included individuals with central, branch, and hemiretinal vein occlusions. Those receiving EYLEA HD every 8 weeks, after initial monthly doses, showed similar improvements in vision to those receiving the approved monthly dosage of EYLEA. The findings showed that about 90% of patients on EYLEA HD sustained their vision gains throughout 36 weeks, maintaining an 8-week dosing interval.

The QUASAR trial, a global, double-masked study, compared the efficacy and safety of EYLEA HD and EYLEA. Patients were divided into groups; one received EYLEA HD every 8 weeks after 3 or 5 initial monthly doses, while the other received EYLEA every 4 weeks. Both groups achieved comparable improvements in vision, measured by best corrected visual acuity (BCVA), at the 36-week mark.

Results indicated that patients on the EYLEA HD 8-week regimen, following 5 initial doses, saw an improvement of 19.1 letters in BCVA, compared to 17.8 letters in those on the EYLEA 4-week regimen. The safety profile for EYLEA HD was consistent with previous findings, with ocular treatment emergent adverse events like increased eye pressure occurring in 5% of patients. Other events included endophthalmitis and retinal vasculitis with very low incidence rates. The rate of intraocular inflammation was 0.5% for EYLEA HD and 1.3% for EYLEA. Hypertension was present in a significant portion of patients, but the incidence of thromboembolic events was relatively low.

Regeneron's Chief Scientific Officer, George D. Yancopoulos, M.D., Ph.D., highlighted the significance of these findings, noting that EYLEA HD has already transformed treatment for conditions like wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The latest data suggests it could similarly benefit patients with retinal vein occlusion by reducing treatment burden.

EYLEA HD is being developed in collaboration with Bayer AG, with Regeneron holding exclusive rights in the U.S. The safety and efficacy of EYLEA HD for RVO have yet to be assessed by any regulatory body.

In addition to the trial, the company provided insight into RVO, a common cause of vision loss in adults and the second most prevalent retinal vascular disease. This condition, resulting from vein blockages in the retina, can lead to vision impairment due to increased vascular endothelial growth factor (VEGF) levels. Anti-VEGF injections, such as EYLEA, are a standard treatment to manage this condition.

EYLEA HD, also known as Eylea™ 8 mg in the European Union and Japan, represents Regeneron's ongoing commitment to enhancing treatments for vision-threatening conditions. The company continues to innovate in ophthalmology, aiming to balance effectiveness with patient convenience by extending the intervals between necessary injections without compromising safety or therapeutic benefits.