Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration approved the extension of dosing intervals for its anti‑VEGF drug EYLEA HD (aflibercept) on April 2 2026. The approval allows patients with wet age‑related macular degeneration and diabetic macular edema to be treated as infrequently as every 20 weeks after a year of successful response, based on 96‑week data from the PULSAR and PHOTON trials.
The 96‑week data from the PULSAR trial showed that 47 % of patients reached 20‑week intervals, while the PHOTON trial reported 44 % of patients achieving the same interval. A “successful response” is defined by sustained efficacy and safety through the two‑year period, meeting the trial’s primary endpoints for visual acuity and retinal thickness. The FDA’s decision reflects confidence that the extended schedule does not compromise patient outcomes.
The approval expands EYLEA HD’s treatment flexibility, directly addressing a key advantage of Roche’s Vabysmo, which offers less frequent dosing. By enabling a broader range of dosing intervals, Regeneron can improve patient adherence, reduce clinical visit burden, and strengthen its competitive position against both Vabysmo and the growing pipeline of Eylea biosimilars. The move is expected to offset erosion in the legacy EYLEA product line and support the company’s ophthalmology franchise, which generated $1.6 billion in 2025—up 36 % from the $1.0 billion in 2024 for EYLEA HD U.S. net sales and part of a broader $4.4 billion decline in total EYLEA U.S. net sales as the legacy product transitions to the HD formulation.
Financially, the approval comes at a time when Regeneron’s gross margins are under pressure. GAAP and non‑GAAP gross margin on net product sales decreased in the fourth quarter and full year 2025 compared to 2024, reflecting the impact of biosimilar competition and the cost of scaling the HD platform. Nevertheless, the company’s vertical‑integration strategy—highlighted by a partnership with Fujifilm Diosynth Biotechnologies and expansion of its Tarrytown campus—provides a robust supply chain that supports the new dosing flexibility.
Regeneron’s leadership emphasized the strategic importance of the approval. CEO Leonard S. Schleifer said, “Regeneron performed well in 2025, with financial strength driven by our four blockbuster medicines and future growth supported by our exciting late‑stage clinical portfolio.” CFO Christopher Fenimore added, “As we look ahead to 2026, our focus remains on prioritizing internal investments, evaluating complementary business development opportunities, and enhancing shareholder returns through share repurchases and dividends, positioning the Company to deliver sustainable growth and long‑term value to shareholders.” Chief Scientific Officer George D. Yancopoulos noted, “We believe these approvals further position Eylea HD as a treatment of choice for certain retinal diseases and underscore our relentless commitment to meeting the needs of patients and the retina specialists who treat them.”
The FDA approval is expected to reinforce Regeneron’s ophthalmology franchise, help the company navigate biosimilar erosion, and maintain its competitive edge in the anti‑VEGF market. The company also anticipates a decision on a pre‑filled syringe version of EYLEA HD in Q2 2026, which would further streamline delivery and support the extended dosing strategy.
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