With $9.2 billion in sales in 2021, Regeneron and Bayer’s Eylea ranked among the top 10 best-selling drugs in the world for the fifth straight year, making it the heavyweight champion in a lucrative and growing macular degeneration market.
But a young contender has emerged with a powerful punch. Roche’s Vabysmo, which won FDA approval early this year, requires fewer doses and over the course of a year and is less expensive.
Regeneron’s answer is its own high-dose version of Eylea—now in phase 3 testing—which would match the duration of Vabysmo.
Until then and beyond, Regeneron will rely on Eylea's familiarity and track record. On more than one occasion during Wednesday’s conference call to announce first quarter earnings, company executives pointed out that Eylea has been injected 50 million times since its launch.
“Eylea is a very well-known entity,” CEO Len 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.”
Eylea, first approved in 2011, is a vascular endothelial growth factor inhibitor approved to treat age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy. It's currently administered every one to two months.
Vabysmo, for its part, picked up approvals in wet AMD and DME earlier this year. The bispecific antibody is dosed every one to four months after a loading series.
Meanwhile, two studies are underway—one in DME patients and the other in those with wet-age macular degeneration—which will determine whether the efficacy and safety of the higher-dose version of Eylea can match the current formulation. They will read out in the second half of this year and Regeneron plans regulatory filings early next year.
The clinical data will guide how Regeneron will market the high-dose version as it considers its use among current and new patients, commercial chief Marion McCourt said on the call.
“We’ll want to wait and look at product profile as the clinical data matures and then certainly as we move into launch preparation planning we’ll be considerate of how the profile matches up against patient need and opportunity, so more to come on the specifics on uptake,” McCourt said.
Regeneron registered $1.52 billion in sales of Eylea in the first quarter, up 13% from the same quarter last year, but down from the fourth quarter figure of $1.54 billion.
For the company overall, revenues came in at $2.97 billion for the quarter, up 17% from the same quarter last year and up 25% excluding revenues of antibody treatment REGEN-COV. The revenue figure topped the consensus estimate of $2.83 billion.
Regeneron had sales of $636 million of the COVID treatment, all outside the United States as the FDA grounded the antibodies in January after they was shown to be ineffective against the omicron variant. REGEN-COV rang up sales of $439 million in the first quarter of last year and $2.87 billion in the fourth quarter of 2021.