Pune, India | August 26, 2025
Regeneron Pharmaceuticals has hit a regulatory roadblock. The FDA issued a Complete Response Letter (CRL) for its application to expand the label of EYLEA HD® (aflibercept 8 mg). Regeneron had asked to extend treatment intervals beyond the current 16-week maximum. The FDA rejected this request, not due to safety or efficacy concerns, but because of dosing interval limits.
The company supported its submission with strong evidence from pivotal studies like PULSAR and PHOTON. These trials showed that fewer injections still produced effective outcomes. Regeneron aimed to reduce the treatment burden for patients. Despite this regulatory hurdle, the company remains committed to greater treatment flexibility. It plans to address the FDA’s feedback and submit a revised application.
EYLEA HD® is currently approved for dosing every 8 to 16 weeks, following three initial doses. The FDA granted this approval in August 2023. Regeneron has since backed it with clinical trials and real-world data. In the PULSAR study, 77% of wAMD patients reached 12-week or longer intervals. Among them, 40% maintained 20-week dosing. In the PHOTON trial, 88% of DME patients sustained treatment intervals of at least 12 weeks. These results support fewer injections—an approach many physicians favor. They believe it reduces clinic visits, improves adherence, and lessens patient fatigue.
Although the FDA capped dosing at 16 weeks, Regeneron believes the data support a second review. The company plans to resubmit the application.
Progress on Additional Indications
Regeneron also seeks FDA approval for using EYLEA HD® in macular edema following retinal vein occlusion (RVO). The QUASAR Phase 3 trial supports this request. Patients treated every eight weeks saw vision gains similar to those on monthly standard-dose EYLEA. Depending on the starting dose, 88% to 93% maintained at eight-week intervals.
The FDA initially aimed to decide by August 19, 2025. However, a major amendment regarding manufacturing extended the review to the fourth quarter of 2025.
The delay began after the FDA inspected Catalent Indiana—the facility that fills EYLEA HD® prefilled syringes. Catalent, now owned by Novo Nordisk, submitted responses to the FDA’s findings. These concerns focused on manufacturing quality—not drug safety or trial performance. Regeneron and Novo Nordisk are actively working to resolve the issues. They remain in direct contact with the FDA to ensure a smooth resolution. Regeneron confirmed that the delay only affects the timeline—not product quality or patient safety.
Real-World Data Strengthens Confidence
Despite these regulatory delays, EYLEA HD® continues to perform well in clinical practice. At ARVO 2025, researchers presented data from nearly 40,000 patients treated with EYLEA HD®. The findings supported longer dosing intervals and showed consistent vision outcomes. EYLEA HD® also compared favorably to alternatives like faricimab.
Regeneron uses both clinical and real-world data to guide its strategy. While addressing FDA concerns, the company continues to invest in new studies, expanded indications, and better delivery systems.
Regeneron remains focused on a clear goal: reducing injection frequency without compromising safety or efficacy. Through this approach, the company continues to lead in advancing retinal care.
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