Closing in on a likely approval to treat retinal vein occlusion (RVO), Roche has presented long-term data that show Vabysmo can maintain visual gains in the indication with a dosing duration stretched for some patients to as long as once every four months.
The results are not surprising considering the immediate success of Vabysmo, which has previously been shown to be able to reduce dosing frequency compared to Regeneron and Bayer’s original formulation for Eylea.
Approved in January of 2022 for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), Vabysmo has already achieved blockbuster status, generating sales of 957 million Swiss francs ($1.1 billion) in the first half of this year.
Tuesday’s results are another testament to Vabysmo’s durability. They are an extended look at patients who received Vabysmo from the phase 3 BALATON and COMINO studies, which compared Roche’s drug to Eylea in branch and central retinal vein occlusion (BRVO and CRVO) over 24 weeks of treatment.
Vabysmo aced that test, which paved the way in May of this year for the FDA to accept Roche’s application for approval in RVO.
In BALATON and COMINO, those who received Vabysmo continued through to 72 weeks on a regimen that allowed individualized dosing intervals "while maintaining the vision gains achieved in the first 24 weeks of the studies," Roche said.
The company did not say how many patients were able to reach the four-month dosing regimen, however.
Also in the studies, Vabysmo showed sustained drying of retinal fluid from baseline to week 72 as measured by a reduction in central subfield thickness. This is another characteristic of Vabysmo that Roche has been quick to emphasize in its market battle with Eylea.
While Vabysmo’s sales have skyrocketed, Eylea’s have leveled off. The $1.5 billion Eylea generated in the second quarter of this year matched the figure from the first quarter and was a 7% decline from the same period of 2022.
In August, Bayer and Regeneron countered, gaining FDA approval for their high-dose version of Eylea. Trial results suggest that high-dose Eylea has superior staying power to Vabysmo.
Eylea gained its approval for both versions of RVO in 2014. In the U.S. there are more than 1 million patients with RVO.