Manufacturer Inspection Report Delays Two Eylea HD Target Action Dates — Eylea HD remains available in the US through vial administration. It is approved with dosing intervals from every eight to 16 weeks in wet AMD and DME, and every eight to 12 weeks in diabetic retinopathy, following three initial monthly doses.

Regeneron announced Aug. 20 that the US FDA had extended the target action dates to Q4-2025 for two Eylea HD (aflibercept 8 mg) submissions. Reports from a recent inspection of a third-party manufacturer constituted a “major amendment” to each submission, regulators said.

The submissions are a prior approval supplement 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 and the broadening of the dosing schedule to include monthly dosing across approved indications.

Regeneron, of Tarrytown, New York, said the delay resulted from an FDA general site inspection at filler Catalent Indiana LLC, which was acquired by Novo Nordisk in December 2024. Novo Nordisk submitted a response in early August 2025 to address the FDA’s findings.

“It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron said in a news release.

Eylea HD remains available in the US through vial administration. It is approved with dosing intervals from every eight to 16 weeks in wet age-related macular degeneration (AMD) and diabetic macular edema (DME), and every eight to 12 weeks in diabetic retinopathy, following three initial monthly doses.

European regulators granted a label extension in June 2025 for Eylea 8 mg with extended treatment intervals of up to six months in wet AMD and DME. In April, the FDA rejected an sBLA to add extended dosing intervals up to every 24 weeks for Eylea HD across all approved indications.

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