Pune, India | August 26, 2025
Regeneron Pharmaceuticals received a Complete Response Letter (CRL) from the FDA that denied its request to expand the EYLEA HD® (aflibercept 8 mg) label beyond the 16-week treatment interval. Although the FDA raised no safety or efficacy concerns, it refused the extension due to dosing interval limitations.
The company built its request on compelling trial data—particularly from the PULSAR and PHOTON studies—demonstrating that fewer injections still delivered strong patient outcomes. Regeneron aimed to ease the treatment burden. Despite the setback, the company remains committed to improving dosing flexibility. It plans to address the FDA’s feedback and resubmit the application. Regeneron continues to innovate in retinal care with a focus on patient-centered, data-driven approaches.
EYLEA HD® currently permits injections every 8 to 16 weeks after an initial three-dose series. The FDA granted this label in August 2023. Since then, Regeneron has supported this approval with both real-world evidence and clinical trials. The PULSAR trial revealed that 77% of patients with wet AMD reached intervals of 12 weeks or longer, and 40% maintained 20-week dosing. The PHOTON study showed that 88% of patients with DME managed intervals of 12 weeks or more. These results clearly support seeking longer intervals.
Physicians responded positively to the potential for fewer injections. They noted benefits such as fewer clinic visits, reduced patient fatigue, and improved long-term adherence. Regeneron believes these data justify reevaluation. Therefore, it plans to make a revised submission after addressing the FDA’s concerns.
Regeneron also seeks FDA approval for EYLEA HD® to treat macular edema following retinal vein occlusion (RVO). Its application relies on the QUASAR Phase 3 trial, which found that patients treated every eight weeks achieved visual gains comparable to those receiving standard-dose EYLEA monthly. Between 88% and 93% maintained eight-week intervals, depending on initial dosing. The FDA originally set an action date of August 19, 2025.
However, a substantial amendment related to manufacturing extended the review into the fourth quarter of 2025. Regeneron continues to engage with regulators and provide data during the review. The company expects this indication to offer RVO patients effective results with less frequent treatment.
The delay stems from an FDA inspection of Catalent Indiana—the facility filling EYLEA HD® prefilled syringes. Novo Nordisk, which acquired Catalent, responded in early August to FDA observations. These issues focused solely on manufacturing—not product safety or trial integrity. Regeneron and Novo Nordisk now collaborate with the FDA to resolve these concerns. Regeneron emphasized that the delay affects only the approval timeline, not the quality of care. Once manufacturing issues are cleared, the company expects steady progress on both label expansion and the RVO indication.
Meanwhile, EYLEA HD® continues performing well in real-world use. At the ARVO 2025 conference, researchers shared data from nearly 40,000 patients, showing extended dosing intervals and consistent vision outcomes. They also compared EYLEA HD® to faricimab and found comparable performance, reinforcing the drug’s value in reducing treatment frequency without sacrificing effectiveness.
Regeneron uses real-world evidence alongside clinical trial results to shape its strategy. The company also invests in new trials, additional indications, and advanced delivery systems. Its goal remains clear: reduce injection frequency while protecting patient outcomes. By addressing regulatory obstacles and advancing innovation, Regeneron continues to lead in retinal care.
