Regeneron Wins Key FDA Approval for Eylea HD in Retinal Disease
The expanded approval for treating Retinal Vein Occlusion allows for less frequent dosing, sharpening its competitive edge against Roche's Vabysmo.
Regeneron Pharmaceuticals (NASDAQ: REGN) has secured a critical U.S. Food and Drug Administration (FDA) approval for its high-dose blockbuster eye treatment, Eylea HD, expanding its use for patients with Macular Edema following Retinal Vein Occlusion (RVO). The decision is a significant strategic victory for the $76.8 billion biotech firm, as it positions Eylea HD as the first and only FDA-approved treatment for RVO that can be administered up to every eight weeks after an initial monthly dosing period.
The approval, announced by the company on Tuesday, is poised to bolster Regeneron’s position in the fiercely competitive ophthalmology market. The company has been working to defend the market share of its lucrative Eylea franchise against Roche’s Vabysmo, a rival drug that has gained significant traction since its launch by offering a less frequent dosing schedule.
Retinal Vein Occlusion is a common cause of vision loss in adults, and the ability to extend the time between injections is a major benefit for patients and physicians. The less burdensome regimen could be a key differentiator in a market where convenience and patient compliance are paramount.
“EYLEA HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies,” said George D. Yancopoulos, M.D., Ph.D., co-Founder and Chief Scientific Officer at Regeneron, in a statement. “And with the addition of a monthly dosing option for all four approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”
The Eylea franchise is the cornerstone of Regeneron's revenue, but it has faced mounting pressure. In the third quarter of 2025, while the new Eylea HD formulation saw U.S. net sales grow to $431 million, the overall franchise revenue declined by 28% to $1.11 billion, partly due to Vabysmo’s inroads. According to industry analysis, Roche’s drug captured a 20% share of the RVO market by the third quarter, highlighting the urgency behind Regeneron's latest label expansion.
The FDA's decision was based on positive results from the Phase 3 QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity gains compared to the original Eylea formulation administered every four weeks. This clinical data provides a strong foundation for Regeneron to market the drug's extended dosing benefits.
In addition to the RVO approval, the FDA also greenlit a monthly dosing option for Eylea HD across all its approved indications, including wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). This provides physicians with maximum flexibility, allowing them to customize treatment regimens based on a patient's specific condition and response.
Despite the positive clinical and regulatory news, a potential headwind remains. In its announcement, Regeneron noted it is working with its supplier, Catalent, to address issues from a July 2025 FDA inspection of a manufacturing facility. While the issues were not specific to Eylea HD, the company plans to submit an application for an alternate pre-filled syringe manufacturer by January 2026 to ensure supply chain stability.
Wall Street analysts have remained largely positive on Regeneron, with 19 of 26 analysts maintaining a 'Buy' or 'Strong Buy' rating on the stock ahead of the announcement. This new approval for RVO, a key battleground indication, is likely to reinforce confidence that Regeneron can effectively manage the lifecycle of its most important product and sustain its long-term growth in the competitive biopharmaceutical landscape.