FDA approves extended dosing intervals up to 20 weeks for EYLEA HD in wAMD and DME

The US Food and Drug Administration has approved the extension of dosing intervals for Regeneron’s EYLEA HD (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following 1 year of successful response based on visual and anatomic outcomes.¹

Regeneron stated that due to the approval, the FDA has updated the EYLEA HD label to include 96-week data from the PULSAR trial in wAMD and the PHOTON trial in DME. In both trials, patients were randomized into 3 treatment groups to receive either EYLEA HD every 3 months, EYLEA HD every 4 months, or EYLEA every 2 months. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON.

Of the EYLEA HD patients who completed week 96 in the PULSAR (n=583) and PHOTON (n=395) trials, majority maintained or further extended their dosing intervals while visual and anatomic improvements remained consistent with those achieved in the first 48 weeks, according to the company.

In PULSAR, 71% and 47% of wAMD patients attained last assigned dosing intervals of ≥16- and ≥20-week intervals, respectively, at week 96. While in PHOTON, 72% and 44% of DME patients attained last assigned dosing intervals of ≥16- and ≥20-week intervals, respectively, at week 96.

Michael A. Klufas, MD, Wills Eye Hospital, commented on the FDA decision in a press release from the company, saying, “The potential for needing only 2 or 3 EYLEA HD injections a year to manage certain retinal diseases is an exciting advance that could benefit my patients who have been successfully treated for a year, particularly as safety, durability and flexibility continue to be driving forces behind treatment decisions. With the extended EYLEA HD dosing schedule and the addition to the label of the compelling 96-week data from PULSAR and PHOTON, I have further confidence that when initiating treatment with EYLEA HD, patients can maintain their visual and anatomic improvements in the long term with a comparable safety profile to EYLEA 2 mg.”

In addition to this approval, the FDA is also currently looking at the EYLEA HD prefilled syringe, which is under review through a Chemistry, Manufacturing and Controls Prior-Approval Supplement and set for an April 2026 action date.

Recently, a post-hoc analysis of the PULSAR randomized clinical trial in participants with polypoidal choroidal vasculopathy (PCV), showed that aflibercept HD 8 mg and aflibercept 2 mg achieved similar visual and anatomic outcomes and supported aflibercept 8 mg as an alternative monotherapy for PCV. The study was led by first author Won Ki Lee, MD, PhD, from the Nune Eye Hospital, Seoul, Republic of Korea.²

References:

1. EYLEA HD (aflibercept) Approved by FDA as First and Only Injectable Anti-VEGF with Dosing Intervals Up to 5 Months for Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME). Published April 2, 2026. Accessed April 3, 2026. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-approved-fda-first-and-only-injectable

2. Charters L. High-dose aflibercept 8 mg as therapy for polypoidal choroidal vasculopathy. Published February 25, 2026. Accessed April 3, 2026. https://www.ophthalmologytimes.com/view/high-dose-aflibercept-8-mg-as-therapy-for-polypoidal-choroidal-vasculopathy