At the J.P. Morgan Healthcare Conference in January, Regeneron CEO Leonard Schleifer said that the company’s new formulation of eye disease treatment Eylea needed “a few more arrows in its quiver,” to regain the edge in its competition with Roche’s Vabysmo.
Three months later, one of those arrows has missed its target as the FDA has sent Regeneron a complete response letter (CRL), rejecting its bid to stretch the administration of high-dose Eylea from a maximum frequency of every 16 weeks to every 24 weeks.
In a brief press release, Regeneron said the FDA "did not agree with Regeneron’s proposal to add additional extended dosing intervals,” offering no further explanation. The regulator did not specify any safety or efficacy issues, Regeneron said.
“Regeneron is evaluating the FDA’s decision and will determine a path forward in due course,” the drugmaker added. The company is likely to provide more information in its quarterly earnings presentation on April 29.
The New York company was hoping to give patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR) an extended dosing option. Eylea HD can be administered at a maximum of every 16 weeks for AMD and DME and every 12 weeks for DR.
A new dosing option would give Eylea HD a much-needed boost against Vabysmo, which can be administered every 16 weeks at a maximum. For both treatments, dosing regimens can be stretched after an initial period of monthly administration.
The CRL came one day after the FDA accepted Regeneron’s application for Eylea HD to be approved for the treatment of macular edema following retinal vein occlusion (RVO) and for broadening the dosing schedule for Eylea HD to every four weeks across all approved indications. Currently, after a loading period, the drug can be given every 8 weeks at a minimum.
These are two more potential “arrows” in Regeneron’s quiver as it attempts to regain the market share it has lost to Vabysmo.
Playing catch-up has been problematic for Regeneron. In 2023, its approval for Eylea HD came two months late because of a manufacturing issue. Even after the nod, sales for the new formulation have been disappointing. In the last two quarters of 2024, for example, sales of Eylea HD declined from $392 million to $305 million.
Since it was approved in early 2022 as a longer-acting answer to Eylea, Roche's Vabysmo sales has scaled up dramatically from 2.36 billion Swiss francs ($2.5 billion) in its first full year on the market to 3.86 billion Swiss francs ($4.2 billion) last year.
Meanwhile, worldwide sales of Eylea—which are reported by Regeneron in the U.S. and by Bayer outside of the U.S.—have stagnated since reaching $9.4 billion in 2021. Last year, Eylea and Eylea HD generated combined revenue of $9.5 billion.
Another concern for both Regeneron and Roche is the recent launch Amgen’s Eylea biosimilar Pavblu, which generated $31 million in sales in the six-plus weeks that it was on the market in the fourth quarter of last year. The impact of the threat will become more clear on May 1 when Amgen reports its first-quarter sales.