FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025

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The US Food and Drug Administration (FDA) has extended the target action dates for Regeneron Pharmaceuticals’ 2 EYLEA HD (aflibercept) Injection 8 mg regulatory submissions to the fourth quarter of 2025.

The 2 regulatory submissions include a Chemistry, Manufacturing, and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe as well as a supplemental Biologics License Application (sBLA) seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications.¹

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

According to a press release from Regeneron, the FDA extended the review periods after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission. Regeneron noted that this delay was to be expected.³ The company noted an inspection was done at Catalent Indiana LLC (recently acquired by Novo Nordisk A/S), the filler for EYLEA HD, in mid-July and was not specific to EYLEA HD. Regeneron stated that based on its review of the observations and Novo's response to the FDA, along with the progress that Regeneron has made with alternate third-party fillers, it anticipates an “expeditious resolution of the filling issues for EYLEA HD.

In April 2025 Regeneron received a complete response letter (CRL) for its supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD across all approved indications. At the time, Regeneron stated it was evaluating the FDA’s decision and will determine a path forward “in due course.”

EYLEA HD is currently approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses.

References:

1. EYLEA HD (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension. Published August 20, 2025. Accessed August 21, 2025. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-applications-expanded-us

2. Harp M. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. Ophthalmology Times. February 10, 2025. Accessed August 21, 2025. https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg

3. Regeneron Reports Second Quarter 2025 Financial and Operating Results. Published August 1, 2025. Accessed August 21, 2025. https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-second-quarter-2025-financial-and-operating