FDA approves EYLEA HD injection 8 mg to treat macular edema following RVO and monthly dosing

On November 19, 2025, Regeneron Pharmaceuticals announced the FDA approved aflibercept (Eylea HD) injection 8 mg to treat patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. Additionally, the federal agency approved a monthly dosing option for all other approved EYLEA HD indications for select patients who could benefit from resuming this dosing schedule.

EYLEA HD is approved for:

• Wet age-related macular degeneration (wAMD)
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
• RVO

"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," said George Yancopoulos, MD, PhD, president, chief scientific officer, Regeneron, in a statement.

"EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for patients with wAMD and DME (following 3 initial monthly doses), every 8 to 12 weeks for patients with DR (following 3 initial monthly doses), and every 8 weeks for patients with RVO (following 3 to 5 initial monthly doses). In clinical trials, some EYLEA HD patients did not maintain a response with extended dosing intervals after successful response to initial monthly doses; these patients may benefit from resuming every 4-week dosing," Regeneron stated in the announcement.

Background on EYLEA and EYLEA HD

EYLEA HD was designed to offer comparable efficacy and safety to the original aflibercept formulation but with fewer injections. Supported by a decade of clinical experience and 16 pivotal trials, EYLEA is approved for several vision-threatening conditions, including DME, DR, wAMD, and retinopathy of prematurity (ROP). EYLEA HD (also known as Eylea 8 mg outside the US) is co-developed with Bayer, which holds marketing rights outside the United States.²

At the time of its approval on February 13, 2023, EYLEA became the first pharmacologic treatment for preterm infants with ROP. The approval was backed by positive data from 2 phase 3 trials, FIREFLEYE and BUTTERFLEYE, which examined EYLEA 0.4 mg vs laser photocoagulation in infants with ROP. Data from both trials showed that approximately 80% of patients in the EYLEA-treated group achieved an absence of active ROP and unfavorable structural outcomes at 52 weeks of age. Additionally, there were no new safety signals observed for EYLEA in either of the trials.²

READ MORE: FDA issues CRL for aflibercept 8 mg extended dosing for all indications

Because retinal blood vessels are mostly completely developed when an infant reaches full term, preterm infants are at an increased risk of developing abnormal blood vessels that can lead to retinal detachment and irreversible vision loss. While mild cases can improve over time without treatment, other cases may need treatment to prevent ROP from worsening, including visual impairment and blindness.

The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, injury to the outer layer of the eye, increased pressure in the eye, eye discomfort, pain, or irritation, bleeding in the back of the eye, blurred vision, vitreous (gel-like substance) detachment, and vitreous floaters.¹

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. Regeneron. Press release. November 19, 2025. Accessed November 19, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment
2. Fitch J. FDA issues CRL for aflibercept 8 mg extended dosing for all indications. Contemporary Pediatrics. Published April 18, 2025. Accessed November 19, 2025. https://www.contemporarypediatrics.com/view/fda-issues-crl-for-aflibercept-8-mg-extended-dosing-for-all-indications