Approval is based on 96-week data from 2 pivotal trials showing majority of EYLEA HD patients maintained their visual and anatomic improvements with extended dosing intervals

New EYLEA HD dosing regimen allows patients with wAMD and DME to be treated as infrequently as 2 to 3 times a year, further extending the widest range of dosing intervals of any approved injectable anti-VEGF

 Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for EYLEA HD^® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the EYLEA HD label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals.

“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,” said Michael A. Klufas, M.D., Wills Eye Hospital - Retina Service. “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.”

With this latest approval, dosing with EYLEA HD can now be individualized for patients with wAMD and DME, some of whom may need treatment as frequently as every 4 weeks, as well as those who can successfully be extended to treatment as infrequently as every 20 weeks, based on criteria described in the U.S. Prescribing Information. This further extends the widest range of dosing intervals of any approved injectable anti-VEGF.

The EYLEA HD label was also updated to include data through 96 weeks from both trials. Of the EYLEA HD patients who completed week 96 (PULSAR n=583, PHOTON n=395), the vast majority maintained or further extended their dosing intervals while visual and anatomic improvements remained consistent with those achieved in the first 48 weeks, including:

• 71% and 47% of wAMD patients attained last assigned dosing intervals of ≥16- and ≥20-week intervals, respectively, at week 96
• 72% and 44% of DME patients attained last assigned dosing intervals of ≥16- and ≥20-week intervals, respectively, at week 96
  
  

“We have once again raised the bar by offering the first and only injectable anti-VEGF therapy that gives patients the potential to be treated as infrequently as every 5 months, significantly reducing the treatment burden for patients who demonstrate a successful response after one year of extended dosing,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of EYLEA. “With EYLEA HD, retina specialists have a treatment option with unparalleled durability - and with the widest range of approved dosing options of any approved injectable anti-VEGF - to meet the individual needs of their patients.”

The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD across approved indications were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment and vitreous floaters.

Beyond approval, the FDA also has a target action date in April 2026 for the EYLEA HD prefilled syringe, which is under review through a Chemistry, Manufacturing and Controls Prior-Approval Supplement.