Upon its January approval by the FDA, Roche’s Vabysmo registered an impressive trio of firsts.
It is the first injectable drug in the United States approved simultaneously to treat both wet-age macular degeneration (AMD) and diabetic macular edema (DME). It’s the first bispecific antibody for the eye. And—most importantly—it is the first injectable that can work for up to four months.
Now, a survey of 20 retina specialists indicates that Vabysmo could soon become the first choice of macular degeneration patients, eventually supplanting Regeneron and Bayer’s powerhouse Eylea.
The survey, conducted by Evercore ISI and focused on early adopters, shows that clinicians believe that Vabysmo provides better retina drying than Eylea. They also think that over the next 12 months, approximately 30% of Eylea users could switch to Vabysmo.
As a result, Evercore has slashed its projection of 2027 U.S. sales of Eylea from $4 billion to $3.5 billion to reflect a “more aggressive erosion in the coming years,” wrote analyst Josh Schimmer in a note to clients.
Last year, Bayer and Regeneron rang up sales of $8.7 billion for Eylea, ranking the blockbuster among the world’s top 10 best-selling drugs for the fifth straight year.
But Vabysmo presents a threat primarily because of its dosing regimen. After a series of four monthly injections, patients can go between one to four months between maintenance injections, depending on their outcomes and anatomy. For Eylea, the regimen is every two months.
Regeneron is working on a higher-dose version of Eylea that could be given every four months. But the best case for approval is the second half of 2023.
Meanwhile, Vabysmo has “considerable time to entrench,” Evercore's Schimmer writes. It’s yet to be determined if high-dose Eylea can “deliver results that are more compelling than Vabysmo," Schimmer wrote, but that "seems unlikely."
This report paints a more optimistic future for Vabysmo than one released in March of this year by Spherix. While its survey of 103 U.S. ophthalmologists predicted rapid uptake of Roche’s drug over the first six months, it also indicated that Regeneron outpaces its competition on manufacturer perceptions and favorability and also is the “clear leader” in practice and patient support.
“Regeneron’s brand will likely maintain first-line preference,” Spherix concluded.
Regeneron's CEO Len Schleifer addressed the threat during the company's first-quarter earnings call last month.
“Eylea is a very well-known entity,” Schleifer said. “If we can transition to a higher dose, with the same kind of safety and allow for longer duration, I think that is a more attractive paradigm than switching to a new molecular mechanism of action with unproven safety.”
This isn’t Roche’s first run at the macular degeneration market. Its aging drug Lucentis made $1.5 billion in 2021. But it faces generic competition this year from Samsung Bioepis’ Byooviz, the first biosimilar approved by the FDA for use in the eye.
Roche also has a surgical implant system Susvimo, which was approved late last year by the FDA and requires even fewer doctor visits than Vabysmo. But reception and uptake so far has been lukewarm.