FDA Approves Aflibercept Injection to Treat Patients With Macular Edema Following RVO

The FDA approved 8-mg aflibercept injection (Eylea HD; Regeneron, Bayer Healthcare) for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing following an initial monthly dosing period. Additionally, an every 4-week dosing option for some patients who may benefit from resuming the dosing schedule was approved for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.¹

Aflibercept is a vascular endothelial growth factor inhibitor that had its efficacy and safety profile established by 16 clinical trials. It is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including DME, DR, macular edema following RVO, and wAMD.^1,2

This approval for the treatment of RVO is based on data from QUASAR (NCT05850520)³, a global, double-masked, active-controlled phase 3 trial evaluating the efficacy and safety of the 8 mg aflibercept injection in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion. In this trial, patients were randomly assigned into 1 of 3 groups: aflibercept injection every 8 weeks following 3 initial monthly doses (group 1); aflibercept injection every 8 weeks following 5 initial monthly doses (group 2); or aflibercept every 4 weeks (group 3).^1-3

QUASAR’s primary end point was mean change in best corrected visual acuity from randomization through week 36, as measured by the Early Treatment Diabetic Retinopathy Study letter score.^1-3

According to the news release from the manufacturer, QUASAR met its primary end point at 36 weeks, with patients receiving aflibercept injection every 8 weeks after either 3 or 5 monthly doses (groups 1 and 2) achieving noninferior visual acuity gains compared with those receiving aflibercept every 4 weeks (group 3). Additionally, the investigators noted that results were consistent across patients with branch retinal vein occlusions and those with central retinal or hemiretinal vein occlusions.¹

The safety profile of aflibercept injection (n = 591) was similar to aflibercept (n = 301) in QUASAR and remained generally consistent with the known safety profile of aflibercept injection in its pivotal trials. Ocular treatment emergent adverse events (TEAEs) occurring in ≥5% of all aflibercept injection patients included increased ocular pressure (5%), and there was 1 case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was approximately 0.5% for aflibercept injection and 1.3% for aflibercept. Hypertension at baseline was also present in about 66% of patients receiving aflibercept injection and 62% of patients receiving aflibercept. Hypertension during the trial was reported in about 8.1% of those treated with the aflibercept injection and 4.7% of those treated with the aflibercept injection. Thromboembolic events occurred in 0.5% and 1.7% of patients in these respective groups.²

"We believe these approvals further position [aflibercept injection] as a treatment of choice for certain retinal diseases and underscore our relentless commitment to meeting the needs of patients and the retina specialists who treat them,” George D. Yancopoulos, MD, PhD, cofounder, board cochair, president, and chief scientific officer at Regeneron, said in the news release. “[Aflibercept injection] is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies. And with the addition of a monthly dosing option for all four approved [aflibercept injection] indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”¹

REFERENCES

1. Regeneron. EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications. News release. November 19, 2025. Accessed November 21, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment

2. Regeneron. 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. News release. December 17, 2024. Accessed November 21, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary

3. A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (QUASAR). ClinicalTrials.gov: NCT05850520. Updated June 4, 2025. Accessed November 21, 2025. https://clinicaltrials.gov/study/nct05850520