FDA Delays Target Action Dates for Two Eylea HD Submissions to Q4 2025 Following Manufacturing Inspection

The U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two regulatory submissions related to Eylea HD (aflibercept injection 8 mg). The delay follows issues identified during a routine inspection of a third-party manufacturing facility.

Submissions Affected

The two submissions currently under review by the FDA include a Prior-Approval Supplement (PAS) for the Eylea HD prefilled syringe, and a Supplemental Biologics License Application (sBLA) that seeks approval for the treatment of macular edema following retinal vein occlusion (RVO) as well as the broadening of the dosing schedule to include monthly (every 4 weeks) dosing across all approved indications.

According to the FDA, the review timeline was extended after determining that additional information submitted after a recent inspection constituted a major amendment, which requires more time for evaluation.

Manufacturing Concerns and Response

The delay stems from findings made during an FDA inspection at Catalent Indiana LLC, the fill-finish facility responsible for these applications. Catalent was acquired by Novo Nordisk A/S in December 2024. The manufacturing concerns had been anticipated and were disclosed by Regeneron during its second-quarter 2025 earnings announcement.

In response to the FDA’s observations, Novo Nordisk submitted a comprehensive corrective action plan in early August 2025. Regeneron expressed optimism in a press release, stating, “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved.”

Current Product Availability

The two submissions currently under FDA review include a Prior-Approval Supplement (PAS) for the Eylea HD prefilled syringe, and a Supplemental Biologics License Application (sBLA) seeking approval for the treatment of macular edema following retinal vein occlusion (RVO) as well as an expanded dosing schedule that would allow for monthly (every 4 weeks) administration across all approved indications.

Global Regulatory Context

In June 2025, the European Commission approved a label extension for Eylea 8 mg, allowing treatment intervals of up to six months for wet AMD and DME in the European Union.

However, in April 2025, the FDA issued a Complete Response Letter (CRL) for a separate sBLA that sought approval for extended dosing intervals of up to 24 weeks. According to Regeneron, the CRL did not raise concerns about the safety or efficacy of Eylea HD within its already approved indications and regimens.