Regeneron to highlight real-world efficacy of aflibercept 8 mg (EYLEA HD) in wAMD, DME, and DR

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Regeneron has announced the upcoming presentation of 27 abstracts, including 8 oral presentations on aflibercept injection 8 mg (EYLEA HD) in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City.¹

Included in the new results and analyses are initial insights into the real-world use of EYLEA HD in clinical practice, which will reinforce the outcomes previously seen in pivotal trials, according to the company.

Real-world analyses of EYLEA HD include treatment of patients with wAMD or DME. Those treated included both those who were previously treatment naive and those who switched from other anti-vascular endothelial growth factor (VEGF) therapies.

Other notable presentations include a network meta-analysis indirectly comparing the efficacy and number of injections received for EYLEA HD and faricimab in patients with DME or wAMD and a modeling analysis of the potential economic benefit of EYLEA HD compared to faricimab for the treatment of patients with wAMD or DME in the US over 3 years.

Boaz Hirshberg, MD, senior vice president of clinical development and internal medicine at Regeneron, commented on the presentations in a press release from the company.

"Our data presentations at ARVO reflect the robust and rapidly growing body of evidence that support the use of EYLEA HD becoming the new standard of care for people living with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy,” said Hirshberg. “This includes new analyses examining the initial real-world experiences of nearly 40,000 patients treated with EYLEA HD, showing, in everyday clinical practice, a positive impact through improved vision and longer dosing intervals for patients. Although early, these data reinforce the value EYLEA HD is bringing to patients with serious retinal diseases.”

Recently, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Regeneron for its supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for aflibercept Injection 8 mg (EYLEA HD) across all approved indications.² Additionally, the FDA recently accepted for review an additional sBLA seeking approval for aflibercept 8 mg for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every-4-week, or monthly, dosing across approved indications.³ The FDA target action date is August 19, 2025, following the use of a priority review voucher.

EYLEA HD clinical trial program

The PULSAR trial in wAMD and the PHOTON trial in DME/diabetic retinopathy are double-masked, active-controlled, pivotal trials conducted globally. 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. Patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 2-month interval if protocol-defined criteria for disease progression were observed in the first year. While patients in all EYLEA groups maintained a fixed 2-month dosing regimen throughout their participation in the 2-year trials.

Results from PULSAR showed that at weeks 48 and 96, the 2 groups treated with aflibercept 8 mg demonstrated non-inferior BCVA gains compared to aflibercept 2 mg administered every 8 weeks. The non-inferiority P values at week 96 for aflibercept 8mg every 12 and 16 weeks were 0.0006 (nominal) and 0.0007 (nominal), respectively.⁴

In both trials, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PULSAR were switched to EYLEA HD at the start of the extension study and immediately assigned to a 3-month dosing interval.

Data from the extension study of PULSAR⁵ showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year while also achieving substantially longer treatment intervals. Additionally, patients who switched from EYLEA Injection 2 mg to EYLEA HD at the beginning of the third year were also able to maintain vision and anatomic improvements through the end of the third year, but with longer dosing intervals and fewer injections.

Additionally, CANDELA was a Regeneron-sponsored phase 2 trial investigating the safety and efficacy of EYLEA HD extended dosing regimens compared to EYLEA in wAMD patients.

References:

1. EYLEA HD (aflibercept) injection 8 mg presentations at ARVO reinforce continued safety and efficacy and highlight early real-world outcomes for patients with serious retinal disease. Published April 28, 2025. Accessed April 28, 2025. https://www.globenewswire.com/news-release/2025/04/28/3069065/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Presentations-at-ARVO-Reinforce-Continued-Safety-and-Efficacy-and-Highlight-Early-Real-World-Outcomes-for-Patients-with-Serious-Retinal-Disease.html

2. Harp M. Regeneron announces FDA issues CRL for aflibercept 8 mg (Eylea HD) sBLA. Ophthalmology Times. Published April 21, 2025. Accessed April 28, 2025. https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg

3. Harp M. Regeneron’s sBLA for Eylea HD accepted for priority review by FDA. Ophthalmology Times. Published April 17, 2025. Accessed April 28, 2025. https://www.ophthalmologytimes.com/view/regeneron-s-sbla-for-eylea-hd-accepted-for-priority-review-by-fda-for-the-treatment-of-macular-edema-following-retinal-vein-occlusion-rvo-

4. Charters L. PULSAR Phase 3 trial 96-week results: Robust treatment response with aflibercept for nAMD. Published January 16, 2024. Accessed April 28, 2025. https://www.ophthalmologytimes.com/view/pulsar-phase-3-trial-96-week-results-robust-treatment-response-with-aflibercept-for-namd

5. Harp M. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. Published February 10, 2025. Accessed April 28, 2025. https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg