Aflibercept 8 mg for RVO Hits Primary Endpoint in Phase 3 QUASAR Trial

Aflibercept 8 mg injection (EYLEA HD) met its primary endpoint in the Phase 3 QUASAR trial, achieving improved vision with extended dosing among a population with macular edema following retinal vein occlusion (RVO).1

Announced by Regeneron, on December 17, 2024, aflibercept 8 mg demonstrated non-inferior vision gains with an every 8-week dosing regimen compared with every 4-week dosing of aflibercept injection 2 mg (EYLEA).

Intending to submit these data to global regulatory authorities, Regeneron announced plans to submit a supplementary biologics license application (sBLA) to the US Food and Drug Administration (FDA) in the first quarter of 2025.

‘All currently FDA-approved anti-VEGF therapies for RVO require monthly dosing, which can be burdensome for a patient,” Seenu M. Hariprasad, MD, chair of the department of ophthalmology and visual science at The University of Chicago, said in a statement. “These impressive data from QUASAR demonstrated that [aflibercept 8 mg] patients with RVO experienced improved vision with fewer injections than [aflibercept] – which could offer a significant advancement in this treatment setting.”

Aflibercept 8 mg was initially approved by the FDA in August 2023 for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR), based on pivotal data from the Phase 3 PULSAR and PHOTON trials.

QUASAR, a global, double-masked, active-controlled Phase 3 trial, measured the efficacy and safety of aflibercept 8 mg to aflibercept 2 mg in a population with RVO. Individuals treated with aflibercept 8 mg received an 8-week dosing regimen, after 3 or 5 initial monthly doses, versus aflibercept 2 mg every 4 weeks.

Upon analysis, the trial met its primary endpoint at 36 weeks, with both aflibercept 8 mg cohorts achieving non-inferior best-corrected visual acuity (BCVA) gains, compared with aflibercept.

Patients who received aflibercept 8 mg after 3 initial monthly doses (n = 293) achieved a mean BCVA improvement of +17.0 letters (least squares mean difference, –0.1; P <.0001), while the 5 initial monthly dose cohort achieved an improvement of +19.1 letters (least-squares mean difference, 0.8; P <.0001), compared with an improvement of +17.8 letters for aflibercept 2 mg.

Approximately 88% of the aflibercept 8 mg after 3 initial monthly doses regimen and 93% of the aflibercept 8 mg after 5 initial monthly doses regimen maintained an every 8-week dosing interval. Safety data in QUASAR found aflibercept 8 mg’s profile (n = 591) similar to aflibercept (n = 301) and generally consistent with the pivotal trials.

Ocular treatment-emergent adverse events (TEAEs) occurred in ≥5% of all aflibercept 8 mg-treated patients, including increased ocular pressure (5%) and 1 case each of endophthalmitis and retinal vasculitis. Intraocular inflammation rates were 0.5% for aflibercept 8 mg and 1.3% for aflibercept 2 mg. Hypertension during the trial was reported in 8.1% of aflibercept 8 mg-treated patients and 4.7% of the aflibercept 2 mg cohort.

Overall, Regeneron indicated these results on aflibercept 8 mg were consistent among those with branch RVOs (BRVOs) and those with central retinal (CRVOs) or hemiretinal vein occlusions (HRVOs).

“With these pivotal results in RVO, [aflibercept 8 mg] with extended dosing has again met the high bar of vision gains and safety seen with standard-of-care [aflibercept],” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, added in a statement. “[Aflibercept 8 mg] has already made a significant impact on the treatment of its 3 approved indications – wet AMD, DME, and diabetic retinopathy – and now has the potential to substantially reduce the treatment burden for patients with RVO.”

References

1. Eylea HD® (aflibercept) injection 8 MG phase 3 trial meets primary endpoint showing improved vision with extended dosing intervals in patients with macular edema following retinal vein occlusion. Regeneron Pharmaceuticals Inc. December 17, 2025. Accessed January 9, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary.
2. Campbell P. Aflibercept 8 mg (eylea HD) approved by FDA for wet AMD, DME, and Diabetic retinopathy. HCP Live. August 23, 2023. Accessed January 9, 2025. https://www.hcplive.com/view/aflibercept-8mg-eylea-hd-approved-by-fda-for-wamd-dme-and-diabetic-retinopathy.