FDA Approves Regeneron's Eylea HD injection for macular edema following RVO

The 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 agency approved a monthly dosing option for some patients who may benefit from resuming this schedule across approved indications. These include wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and RVO.¹

According to the company, this approval for the treatment of RVO is based on data from the phase 3 QUASAR trial (NCT05850520). The global, double-masked, active-controlled trial is evaluating the efficacy and safety of aflibercept 8 mg compared with aflibercept 2 mg in patients with RVO, including those with central, branch, and hemiretinal VO.²

The trial met its primary end point at 36 weeks. Patients who received aflibercept 8 mg every 8 weeks (after either 3 or 5 monthly doses) achieved noninferior visual acuity gains compared with those who received aflibercept 2 mg given every 4 weeks. The company noted that aflibercept 8 mg results were consistent across patients with branch RVO and those with central retinal or hemiretinal VO.

Commenting on the agent's approval, George D. Yancopoulos, MD, PhD, co-founder, board co-chair, president, and chief scientific officer at Regeneron, said, "We believe these approvals further position Eylea HD [high dose] 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 4 approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”

Regarding the prefilled syringe (PFS) option of high-dose aflibercept 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 aflibercept 8 mg). In the CRL, the FDA noted unresolved issues at Novo Nordisk's Bloomington, Indiana, plant.

In August 2025, Regeneron announced that the FDA had rejected a new blood cancer therapy due to problems at the same Novo Nordisk–owned site. In the same month, it was revealed that quality control lapses were found in November 2024, which included the discovery of a “pest” on the manufacturing line.³

Regeneron also noted its plans to submit an application to the FDA by January 2026 that will include an alternative PFS manufacturing filler for the aflibercept 8 mg biologics license application.

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. 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 end point in phase 3 QUASAR trial in patients with retinal vein occlusion. 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. Filkins K. Regeneron receives another CRL for its Eylea 8 mg. October 29, 2020. Accessed November 21, 2025. https://www.ophthalmologytimes.com/view/regeneron-receives-another-crl-for-its-eyelea-8-mg