Roche’s long-awaited challenge to Regeneron’s dominance in the ophthalmology market may soon be coming to a head, according to a recent analyst report from GlobalData.
The companies’ latest earnings reports show Roche’s Vabysmo sales skyrocketing while heavyweight Eylea plateaus. For the first quarter of 2024, Roche reported total global sales of 847 million Swiss francs ($933 million) for Vabysmo, for an analyst-estimate-smashing year-over-year increase of 108%, while noting that the eye medicine was its biggest growth driver for the quarter.
Regeneron, meanwhile, tallied first-quarter sales of $2.25 billion for both Eylea and its recently launched higher-dose sibling, Eylea HD; the number combines Regeneron’s U.S. sales of the drugs and partner Bayer’s international performance and represents a 1% drop compared to the same period last year.
Eylea HD didn’t launch until last August and has seen a steady uptake since then, with $200 million in U.S. sales last quarter, meaning the overall decline came from regular-dose Eylea: The med saw a 16% decrease in the U.S. alone, which the company attributed to “changing market dynamics, resulting in lower volumes and a lower net selling price.”
That continues a trend seen in Regeneron’s last full-year report, when total Eylea sales fell 3% from 2022 to $9.38 billion. Vabysmo, meanwhile, is on the uptick, with 324% growth last year that brought its 2023 haul to nearly 2.4 billion Swiss francs ($2.64 billion). GlobalData’s report suggests that Vabysmo will rake in $3.3 billion this year from the seven major markets: the U.S., France, Germany, Italy, Spain, the U.K. and Japan.
Along with growing Vabysmo’s market share, Roche is also in the process of further strengthening its foothold in the ophthalmology space. According to GlobalData, the Swiss pharma is planning to relaunch its Susvimo drug-eluting implant for wet age-related macular degeneration (wAMD) in the third quarter of this year, following a recall that took it off the market in the fall of 2022. Roche is also reportedly aiming to expand Susvimo’s indication into additional eye diseases, including diabetic macular edema (DME) and diabetic retinopathy.
“If Roche’s Vabysmo continues to provide promising sales figures for the foreseeable future, in addition to the company’s anticipated re-launch of Susvimo and Suvsimo’s label expansion, Roche will have put itself on track to becoming an industry leader within the ophthalmological space,” Sara Reci, a senior pharma analyst at GlobalData, said in the report.
That said, Vabysmo still faces stiff competition from Eylea HD, which, like Vabysmo, reduces the frequency of injections to as few as once every four months—following a once-monthly schedule for the first three months—compared to original Eylea’s bimonthly pattern. Both Eylea HD and Vabysmo are approved to treat AMD and DME while Eylea HD also has the FDA OK to treat diabetic retinopathy, and Vabysmo is also indicated for retinal vein occlusion. Roche and Regeneron have each recently claimed that their respective drugs are now the standard of care in both AMD and DME.
“The launch of Eylea HD is anticipated to impact Vabysmo sales, with primary research with key opinion leaders (KOLs) indicating that Eylea HD’s durability was on par or better than Vabysmo,” Reci said.
Regeneron has said it’s expecting to see a major sales bump for Eylea HD starting this quarter, as the drug’s permanent J-code for billing purposes didn’t take effect until April 1—though Roche’s pharma CEO Teresa Graham said on an investor call that month that the company had yet to see any sales impact on Vabysmo since that date.
In addition, while separate studies of Vabysmo and Eylea HD have so far appeared to give an edge to the latter, GlobalData cited a KOL who noted that inclusion and exclusion data for each drug’s studies have been different, “so it’s not really comparable.” According to GlobalData, the comparison may become clearer with the impending release of results from a meta-analysis that compared seven trials of the two drugs and, according to Roche, concluded that Vabysmo achieved a greater reduction in central subfield thickness in AMD and DME patients.