FDA accepts Regeneron's sBLA for Eylea HD as priority review

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) from Regeneron for the high-dose (HD) formulation of aflibercept (EYLEA HD).¹

The sBLA seeks approval for EYLEA HD 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. The company noted that the FDA target action date is August 19, 2025, following the use of a priority review voucher.¹

The HD formulation is a longer-acting version of the original aflibercept drug, and through less frequent injection, it is designed to be more convenient to the patient, reducing treatment burden. In August 2023, data from Regeneron’s Phase III PULSAR trial confirmed that even at dosing intervals at least 12 weeks long, high-dose Eylea did not sacrifice vision gains while also helping patients maintain their treatment schedules.

The sBLA is supported by data from the phase 3 QUASAR trial investigating EYLEA HD in RVO. As previously reported, results from the QUASAR trial³ showed that it met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA (aflibercept) Injection 2 mg dosed every 4 weeks.

The safety profile of EYLEA HD in the QUASAR trial was similar to EYLEA and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. The company did note that increased ocular pressure (5%) was the only ocular treatment-emergent adverse event that occurred in ≥5% of all EYLEA HD patients, compared to 1.7% of EYLEA patients.

Regeneron has also filed an application with the FDA for the use of pre-filled syringes (PFS) of high-dose aflibercept in the US. Approval and launch of these PFSs are expected by mid-2025.⁴ Additionally, Bayer announced the submission of an application to the European Medicines Agency (EMA) seeking to expand the indication for aflibercept 8mg. Aflibercept is being jointly developed by Bayer and Regeneron.⁵

References:

1. EYLEA HD (aflibercept) injection 8 mg sBLA accepted for FDA Priority Review for both the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in approved indications. Published April 17, 2025. Accessed April 17, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-sbla-accepted-fda-priority

2. FDA Action Alert: Regeneron, Sanofi and Abeona. BioSpace. April 14, 2025. Accessed April 15, 2025. https://www.biospace.com/fda/fda-action-alert-regeneron-sanofi-and-abeona

3. Harp M. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. Ophthalmology Times. Published February 10, 2025. Accessed April 17, 2025. https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg

4. Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference. Regeneron. January 13, 2025. Accessed April 15, 2025. https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-business-updates-and-highlights-broad/

5. Hayes, H. Bayer files EMA application for aflibercept 8mg in third indication, retinal vein occlusion. Modern Retina. April 9, 2025. Accessed April 14, 2025. https://www.modernretina.com/view/bayer-files-ema-application-for-aflibercept-8mg-in-third-indication-retinal-vein-occlusion