Roche's Vabysmo looks to escalate Eylea fight as FDA takes up review in retinal vein occlusion

As Roche's Vabysmo takes a bite out of Regeneron's Eylea sales, the drug has moved one step closer toward an approval in another of its rival drug's uses.

The FDA accepted Roche's Vabysmo application for the treatment of macular edema following retinal vein occlusion (RVO), possibly setting up another market battle with Regeneron and Bayer’s Eylea. Eylea won an FDA approval in this use in 2014.

Roche's application is based on two phase 3 studies that showed Vabysmo delivered early and sustained vision improvement while proving non-inferior visual acuity gains compared with Eylea at 24 weeks, the company's Genentech unit said in a release.

The approval would give Vabysmo its third indication, following its early 2022 approval for wet or neovascular age-related macular degeneration and diabetic macular edema. Vabysmo is the first bispecific antibody approved for the eyeball and is already endorsed by drug regulators in more than 60 countries, according to Genentech.

Next, Genentech will submit RVO trial results to other global health authorities, including the European Medicines Agency, the company said.

So far, Eylea is already feeling the sales heat from its competition. On Bayer's fourth-quarter and full-year earnings call, pharmaceutical division chief Stefan Olerich highlighted pricing challenges and warned that Eylea wouldn't have “the same type of success that we’ve seen in prior years.”

In 2023's first quarter, Eylea sales took a sales hit as customers turned to Vabysmo and its longer-acting formula. Meanwhile, Regeneron is anticipating an approval for its own longer-acting version of the drug, which is slated for a June 27 FDA decision.

Eylea pulled in $1.43 billion in sales during the first quarter, a 5% decline. Meanwhile, Vabsymo scored $486 million in sales and quickly became Roche’s top growth driver. Genentech projects $2 billion in peak annual sales for the drug.

So far, Vabysmo has captured 12% of the age-related macular degeneration market and 5% of the diabetic macular edema patient pool, with 70% to 80% of patient switches coming from Eylea, Roche’s pharma head, Teresa Graham said on Roche’s first-quarter earnings conference call.