Regeneron’s EYLEA HD Succeeds in Phase 3 Trial for Retinal Vein Occlusion, Paving Way for 2025 FDA Submission

EYLEA HD Success in Phase 3 Trial:
Regeneron Pharmaceuticals announced that EYLEA HD (aflibercept) Injection 8 mg met its primary endpoint in the Phase 3 QUASAR trial for treating macular edema following retinal vein occlusion (RVO)14.

Extended Dosing Intervals:
The trial demonstrated that EYLEA HD administered every 8 weeks achieved non-inferior vision gains compared to the standard monthly dosing of EYLEA 2 mg14.

Vision Improvements:
Key findings at 36 weeks showed mean vision improvements of 17.0-19.1 letters for EYLEA HD groups versus 17.8 letters for EYLEA1.

High Patient Retention:
About 90% of EYLEA HD patients maintained 8-week dosing intervals, indicating a potential reduction in treatment burden1.

Safety Profile:
The safety profile of EYLEA HD remained consistent with previous trials, with comparable rates of adverse events14.

FDA Submission Planned:
Regeneron plans to submit a supplementary biologics license application to the FDA in the first quarter of 202514.

Previous FDA Rejection:
The FDA previously issued a complete response letter (CRL) for a higher dose regimen of EYLEA due to issues unrelated to clinical efficacy or safety2.

Long-term Efficacy:
Previous studies have shown that EYLEA HD can provide durable vision gains and anatomic improvements with extended dosing intervals in patients with diabetic macular edema3.

Sources:

1. https://www.stocktitan.net/news/REGN/eylea-hd-aflibercept-injection-8-mg-phase-3-trial-meets-primary-psuy1ick6wbe.html

2. https://www.managedhealthcareexecutive.com/view/fda-rejects-higher-dose-of-eylea

3. https://www.globenewswire.com/news-release/2024/10/18/2965754/0/en/Three-year-Results-for-EYLEA-HD-aflibercept-Injection-8-mg-Demonstrate-Continued-Durable-Vision-Gains-and-Anatomic-Improvements-with-Extended-Dosing-Intervals-in-Patients-with-Diab.html

4. https://eyewire.news/news/eylea-hd-phase-3-trial-meets-primary-endpoint-showing-improved-vision-with-extended-dosing-intervals-in-patients-with-rvo