Regeneron's EYLEA HD injection 8 mg approved by FDA for the treatment of macular edema following RVO

The US Food and Drug Administration (FDA) has approved aflibercept injection 8 mg (EYLEA HD) from Regeneron Pharmaceuticals for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.

Additionally, the FDA approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications, which include wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.¹

According to the company, this FDA approval for the treatment of RVO is based on data from the phase 3 QUASAR trial (NCT05850520). It is a global, double-masked, active-controlled phase 3 trial evaluating the efficacy and safety of EYLEA HD, compared to EYLEA, in patients with retinal vein occlusion (RVO), including those with central, branch, and hemiretinal vein occlusions.²

Phase 3 QUASAR Trial Results

The trial met its primary end point at 36 weeks, with EYLEA HD patients dosed with 8 mg every 8 weeks (after either 3 or 5 monthly doses) achieving noninferior best-corrected visual acuity (BCVA) gains compared with those receiving EYLEA 3 mg, dosed every 4 weeks (n = 301). The company noted that EYLEA HD results were consistent across patients with branch retinal vein occlusions (BRVO) and those with central retinal or hemiretinal vein occlusions (CRVO/HRVO).

The company presented data from the trial at the 25th European Society of Retina Specialists (EURETINA), in Paris, France, in September 2025.³ Those results suggested that aflibercept 8 mg delivered every 8 weeks—for both patients receiving 3 (n = 293) or 5 (n = 298) initial monthly injections—showed the aforementioned noninferior BCVA gains as well as robust reductions in central subfield retinal thickness (CRT) at Week 36, both overall and across BRVO and CRVO/HRVO subtypes.

For BVCA, the least-squares (LS) mean change from baseline for the overall RVO population was +17.4 letters (72.8 letters at Week 36; P <.0001) and +18.3 letters (74.6 letters at Week 36; P <.0001) for the 3- and 5-monthly initial dose groups receiving 8-mg doses, respectively, compared with the 2-mg group (+17.5 letters; 72 letters at Week 36).

Subgroup results were similar, with the 8-mg groups showing similar significant letter gains from baseline. For the BRVO subgroups, the 3 initial monthly injections (+18.3 letters; 76.6 letters at Week 36; P = .0018) and 5 initial monthly injections (+19.2 letters; 78.1 letters at Week 36; P <.0001) showed gains compared with the 2-mg group (+19 letters; 76.6 letters at Week 36). For the CRVO/HRVO subgroups, both groups once again showed gains compared with the 2-mg group (+15.9 letters; 67.4 letters at Week 36) for both the 3 initial monthly injections (+16.6 letters; 68.3 letters at Week 36; P = .0027) and 5 initial monthly injections (+17.2 letters; 70.6 letters at Week 36; P = .0008) groups.

At Week 36, in the overall RVO population, the 8-mg dose groups reported 2.7 (LS mean injections, 6.1) and 1.8 (LS mean injections, 6.9) fewer total injections for the 3- and 5-monthly initial dose groups, respectively, compared with the 4-week dosing (LS mean injections, 8.8). Among the BRVO (2-mg group, n = 149; 3 initial monthly doses, n = 159; 5 initial monthly doses, n = 159) and the CRVO/HRVO (2-mg group, n = 152; 3 initial monthly doses, n = 134; 5 initial monthly doses, n = 139) subgroup populations, the difference in LS mean injections were nearly identical to the full population.

George D. Yancopoulos, MD, PhD, co-founder, board co-chair, president, and chief scientific officer at Regeneron, commented on the approval, saying, "We believe these approvals further position EYLEA HD 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. EYLEA HD 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 EYLEA HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”

Additional FDA Submissions for EYLEA Prefilled Syringe

Regarding the prefilled syringe (PFS) option of high-dose (HD) Eylea 8 mg, which received a complete response letter (CRL) from the FDA in October, the company noted it continues to coordinate with Catalent Indiana (part of Novo Nordisk A/S) as it works to resolve outstanding issues identified from a July 2025 FDA general site inspection (not specific to EYLEA HD). In the CRL, the FDA noted unresolved issues at the Bloomington, Indiana, plant of Novo Nordisk.

In August of 2025, Regeneron announced the FDA rejected a new blood cancer therapy due to problems at this same Novo Nordisk-owned site, and in the same month it was revealed that the quality control lapses were found in November 2024, which included finding a “pest” on the manufacturing line.⁴

Regeneron also noted its plans to submit an application to include an alternate PFS manufacturing filler for the EYLEA HD BLA to the FDA by January 2026.

References:

1. 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. Published November 19, 2025. Accessed November 21, 2025. https://www.globenewswire.com/news-release/2025/11/19/3191435/0/en/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.html

2. Harp MD. Regeneron announces aflibercept 8mg injection meets primary endpoint in phase 3 QUASAR trial in patients with retinal vein occlusion. Published December 17, 2024. Accessed November 21, 2025. https://www.ophthalmologytimes.com/view/regeneron-announces-aflibercept-8mg-injection-meets-primary-endpoint-in-phase-3-quasar-trial-in-patients-with-retinal-vein-occlusion

3. Chaudary V, Gale R, Hariprasad SM, et al. Results from the QUASAR Study: Comparable Vision Gains with Aflibercept 8 mg and 2 mg in Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion. Presented at: EURETINA 2025; Paris, France. https://congresspublications.bayer.com/download/NEW_2025_QUASAR%20RVO%20Outcomes%20LB_CHAUDHARY_ORAL%20PRESENTATION_10SEP25.pdf

4. Filkins K. Regeneron receives another CRL for its Eylea 8 mg. Published October 29, 2020. Accessed November 21, 2025. https://www.ophthalmologytimes.com/view/regeneron-receives-another-crl-for-its-eyelea-8-mg