FDA Approves Aflibercept Injection for Macular Edema Following Retinal Vein Occlusion

The FDA approved Regeneron’s aflibercept (Eylea HD) 8 mg injection for treating macular edema following retinal vein occlusion (RVO), according to a news release.¹ Four- and 8-week dosing options were both approved for the drug, making aflibercept regimens flexible and personalized for patients with macular edema.

“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,” George Yancopoulos, MD, PhD, co-founder, president, and chief scientific officer at Regeneron, said in the news release. “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.”

READ MORE: FDA Approves Aflibercept-Boav as Biosimilar to Aflibercept for Diabetic Macular Edema

Macular Edema and RVO

Macular edema is a retinal eye condition that occurs when fluid builds up in the macula. The buildup then causes swelling and can distort vision, make objects look blurry, and skew the presentation of colors. Treatment for macular edema can be challenging because it often requires targeting the underlying cause of the condition. These causes include diabetes, genetic disorders, physical damage to the eye, and more.²

One of those underlying causes, which is also a key factor in aflibercept’s approval, includes RVO—which is a small blood vessel blockage resulting in the potential development of vision blur or loss.^2,3

Impacting over 16 million people worldwide, RVO is more prominent than macular edema. However, macular edema is a significant issue among the diabetic population, with approximately 745,000 US patients having both diabetes and macular edema—otherwise known as diabetic macular edema (DME).⁴

The FDA’s approval of aflibercept is now designed to benefit patients who have experienced both RVO and macular edema. While previous evidence has shown intravitreal aflibercept as a safe and effective treatment for central RVO-induced macular edema,⁵ the nonintravitreal-injection option may be more convenient for patients.⁶

Aflibercept’s Flexible Dosing Options

“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,” continued Yancopoulos.¹

Following the approval, patients with macular edema caused by RVO will soon be able to access aflibercept on either a 4- or 8-week dosing schedule following the initial monthly dosing period. Although the drug was originally approved for the 8-week schedule, the 4-week option was also made available for patients with certain indications that may benefit more from shorter dosages.

Patients with wet age-related macular degeneration, DME, diabetic retinopathy, and RVO are those that would benefit most from the 4-week schedule. However, with aflibercept specifically treating RVO-induced macular edema, either dosing schedule should be viable for the patient, making this approval significantly geared toward a personalized treatment approach.

Proof of Aflibercept’s Efficacy in Treating RVO

This approval comes from data in the phase 3 QUASAR trial, examining the efficacy and safety of 8 mg aflibercept compared with 2 mg injections among patients with RVO. Meeting its endpoints by week 36, the 8 mg injection exhibited non-inferiority when compared with 2 mg. These results were consistent for patients with central, branch, or hemiretinal RVO.¹

Trial researchers also uncovered that 3% or fewer patients experienced adverse events, including conjunctival hemorrhage, ocular discomfort, eye pain, and blurred vision.

With multiple options to treat a variety of indications, aflibercept could be a revolutionary development within the eye treatment space. As Regeneron works with its partners to bring the drug to market and formulate its proper administration, aflibercept injections will start rolling out come 2026.

“In regard to the Eylea HD pre-filled syringe, Regeneron continues to coordinate with Catalent Indiana, LLC (part of Novo Nordisk A/S) as it works to resolve the outstanding issues identified from a July 2025 FDA general site inspection (not specific to EYLEA HD),” concluded the authors of the news release.¹ “As previously disclosed, Regeneron also plans to submit to the FDA an application to include an alternate PFS manufacturing filler for the EYLEA HD biologics license application by January 2026.”

READ MORE: Eye Health Resource Center

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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. News Release. Regeneron Pharmaceuticals, Inc. November 19, 2025. Accessed November 20, 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. Porter D. What is macular edema? American Academy of Ophthalmology. September 23, 2024. Accessed November 20, 2025. https://www.aao.org/eye-health/diseases/what-is-macular-edema

3. Retinal vein occlusion (RVO). Cleveland Clinic. June 19, 2023. Accessed November 20, 2025. https://my.clevelandclinic.org/health/diseases/14206-retinal-vein-occlusion-rvo

4. Lazarus R. What is macular edema? Optometrists Network. Accessed November 20, 2025. https://www.optometrists.org/general-practice-optometry/guide-to-eye-conditions/guide-to-retinal-diseases/what-is-macular-edema/

5. Rhoades W, Dickson D, Nguyen QD, et al. Management of macular edema due to central retinal vein occlusion - the role of aflibercept. Taiwan J Ophthalmol. 2017 Apr-Jun;7(2):70-76. doi: 10.4103/tjo.tjo_9_17.

6. Post: intravitreal injections: a common treatment for retinal conditions. Retina and Vitreous Surgeons of Utah. Accessed November 20, 2025. https://www.utahretina.com/intravitreal-injections-a-common-treatment-for-retinal-conditions/