Trials cue up new use for Roche's eye disease drug Vabysmo

Roche is on course for a third indication for its fast-growing ophthalmic disease therapy Vabysmo, after a pair of phase 3 trials showed it was effective at improving eyesight in people with retinal vein occlusion (RVO).

Vabysmo (faricimab) met its primary endpoint in two clinical trials – BALATON and COMINO – showing it was as good as Bayer and Regeneron's market-leading Eylea (aflibercept) in achieving gains in visual acuity, and better at preventing blood vessel leakage in the retina.

RVO is the second most common retinal vascular disorder and is a significant cause of visual impairment and loss, mainly in people aged over 65, with an estimated 17 million cases worldwide.

That makes it a major growth area for Vabysmo, which came out of the gate strongly after its approval in early 2022 for wet age-related macular degeneration and diabetic macular oedema. It is already among Roche's top five growth products, with sales of CHF 591 million ($639 million) last year.

In the BALATON and COMINO studies, patients were treated with six monthly injections of either Vabysmo or Eylea, with the primary endpoint visual acuity gains at week 24. The average vision gains from baseline were comparable between the two treatments in both studies, according to Roche, equivalent to around 17 letters on a standard eye chart.

Roche's drug was also comparable to Eylea on achieving drying of retinal fluid from baseline, measured by reduction in central subfield thickness (CST), a key secondary endpoint, but more patients on Vabysmo had an absence of blood vessel leakage in the retina.

In BALATON, 34% of Vabysmo patients had no leakage, compared to 21% of the Eylea group, while for COMINO those percentages were 44% and 30%, respectively.

Roche noted that the studies are still ongoing, and will continue to follow patients out to 72 weeks. During the extended follow-up the trials will test Vabysmo given every four months, which if effective could give it an edge over Bayer and Regeneron's drug and help reduce the number of injections patients need into their eye.

They are, however, working on a higher-dose version of Eylea that could reach the market later this year and could also offer dosing intervals of four months. Regeneron reported earlier this month that US sales of the drug came in at $6.3 billion in 2022, up 8% on 2021.

Bayer is due to report its fourth quarter on 28th February, but recorded €2.4 billion ($2.6 billion) in sales of the drug in the first nine months of last year.

That means Roche has a lot of catching up to do, but the company is claiming that around two-thirds of its Vabysmo patients are switching from Eylea, and analysts have suggested it will easily grow into a $1 billion-plus product.

Meanwhile, Regeneron has just been awarded another FDA approval for Eylea, adding retinopathy of prematurity to its current uses in AMD, RVO, and diabetic retinopathy.