Look out, Eylea: Roche's Vabysmo wins new use in retinal vein occlusion

The market battle between Roche’s Vabysmo and Regeneron and Bayer’s Eylea just cranked up a notch. With Vabysmo’s FDA approval to treat retinal vein occlusion (RVO), the rival eye meds share another indication.

Vabysmo's approval in RVO comes after the drug won prior FDA nods in wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the trio of retinal conditions affect around 3 million people in the U.S., according to a recent release from Roche's Genentech.

Roche showed Vabysmo’s merits in two phase 3 trials, which formed the basis of the FDA’s decision. In the studies, called BALATON and COMINO, the drug proved noninferiority to its rival Eylea in visual acuity gains at 24 weeks, along with rapid and robust drying of retinal fluid, according to the company.

The improved drying was sustained through 72 weeks, longer-term data show.

“The efficacy and safety profile of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated,” Genentech’s chief medical officer and head of global product development, Levi Garraway, M.D., Ph.D., noted in the release.

Eylea won its FDA approval in RVO in 2014.

As for Vabysmo, the med has so far proved a worthy competitor to the long-dominant Eylea.

During this year’s second quarter, Eylea sales slid 7% year over year to $1.5 billion. Meanwhile, Vabysmo has already met blockbuster status since its initial approval in January 2022.

Roche's drug brought in 957 million Swiss francs ($1.1 billion) in the first six months of 2023 and now serves as the company's top growth driver. 

Bayer is well aware of the threat, with pharmaceutical division chief Stefan Orlerich warning that Eylea wouldn’t have “the same type of success that we’ve seen in prior years” on the company’s fourth-quarter and full-year 2022 earnings call.

Eylea is countering with its high-dose version, which was approved in August after a surprise manufacturing-related rejection in June. Phase 3 trial results suggest the new option has superior staying power to Vabysmo.

Roche is currently evaluating Vabysmo’s long-term safety and tolerability in AMD and DME and is assessing its use in underrepresented patient populations with DME, plus a subpopulation of wet AMD that’s highly prevalent in Asia, Genentech said.