Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response (CR) Letter for the supplemental Biologics License Application (sBLA) seeking approval of a pre-filled syringe version of Eylea HD (aflibercept). The rejection was based solely on unresolved issues at a third-party manufacturing facility operated by Novo Nordisk in Bloomington, Indiana.

The FDA identified deficiencies at the site during an inspection earlier this year. The facility, formerly owned by Catalent and acquired by Novo Nordisk as part of its $16.5 billion acquisition in December 2024, recently received an Official Action Indicated (OAI) classification—signifying an “unacceptable state of compliance.” These findings have delayed FDA’s approval decision for Regeneron’s pre-filled syringe version of Eylea HD.

Despite the setback, Regeneron reaffirmed its commitment to advancing Eylea HD’s product enhancements. The company plans to resubmit its application using a new syringe manufacturing partner by January 2026, which would initiate a four-month FDA review period.

“We continue to execute on our plan to submit an application to add an alternate prefilled syringe filler by January 2026,” said Dr. Len Schleifer, President and Chief Executive Officer of Regeneron. “Future product enhancements such as a four-week dosing interval, the inclusion of macular oedema following retinal vein occlusion, and a pre-filled syringe administration are key to fully unlocking Eylea HD’s commercial potential.”

Eylea HD is currently approved in the U.S. for treating wet age-related macular degeneration (AMD), diabetic macular oedema, and diabetic retinopathy. Regeneron has additional applications under FDA review, including a potential new indication for macular oedema following retinal vein occlusion (RVO) and an expanded four-week dosing schedule across approved uses. Decisions on these submissions are expected in late November and December 2025.

Eylea HD remains a significant growth driver for Regeneron, with U.S. sales of Eylea and Eylea HD reaching $1.1 billion in Q3 2025, up 28 per cent year-over-year. The company continues to transition patients to the high-dose version, which offers longer intervals between treatments and improved convenience.

To strengthen its long-term manufacturing resilience, Regeneron is investing heavily in expanding its infrastructure. The company’s nearly $3.6 billion headquarters expansion in Tarrytown, New York, includes a new fill/finish facility in Rensselaer. Additionally, Regeneron has entered a $3 billion collaboration with Fujifilm Diosynth to enhance its U.S. production capacity—bringing total domestic investments to more than $7 billion.

Dr. Schleifer added, “We’ve emphasized the importance of domestic manufacturing for over a decade. With our new fill/finish facility set to come online next year, we are strengthening our ability to meet patient needs and support the continued growth of Eylea HD.”

Eylea HD continues to play a pivotal role in advancing retinal care, and Regeneron remains committed to expanding treatment options and improving access for patients living with serious eye diseases.