May 24, 2022

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Roche looks to rival a blockbuster therapy with newly approved vision drug

Roche announced Friday that it received Food and Drug Administration approval for the first-ever bispecific antibody treatment for two common causes of vision loss, setting the stage for a battle with Regeneron, which markets a blockbuster drug in this space.

The approval comes just a week after two studies published in The Lancet showed that the drug, Vabysmo, proved safe and effective in improving or maintaining vision in patients with wet age-related macular degeneration and diabetic macular edema, conditions that together affect nearly 1.9 million people in the U.S. and 40 million worldwide.

The antibody drug latches onto vascular endothelial growth factor-A and angiopoietin-2 to block signals linked to inflammation and blood vessel leakage — both of which are major problems for patients with these eye conditions.

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The recent studies showed that the drug worked about as well as Regeneron’s drug, Eylea, which dominates the market. Christopher Brittain, Roche’s head of ophthalmology research, said one advantage with Vabysmo is that it can be administered as infrequently as every three or four months, compared to once every month or two for Eylea.

“That treatment burden just prevents many patients from getting the optimum therapeutic regimen,” he said. “Maybe they fall ill or maybe they can’t come in that frequently, or they don’t have the caregivers. There are lots of reasons.”

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The two Lancet studies showed that about half of patients who received Vabysmo across Roche’s four Phase 3 trials could go four months between injections, while three out of every four could go at least three months between shots. In practice, Brittain said, doctors will base the frequency of dosing on results from eye scans and vision tests.

Roche’s studies, which directly compared Vabysmo and Eylea, did not show that its drug was better than the Regeneron product, but instead showed what the FDA calls “non-inferiority,” meaning its effects were comparable.

“Clearly, it would be nice to have superiority of vision gains,” Brittain said. “But I think the extended durability is of massive importance for patients.”

Another advantage he pointed to: Vabysmo’s infrequent administration makes it cheaper over time. Roche is listing the drug at $2,190 a dose. And while patients need monthly shots in the beginning, less frequent administration over time means that the drug’s cost in the second year of treatment could be half its cost in the first year. The list price for Eylea is about $1,850 per dose.

A spokesperson for Genentech, the South San Francisco Roche subsidiary that began developing the drug over a decade ago, said that Vabysmo will be available to patients within weeks. And the drug is currently under review by the European Medicines Agency.

Competition in this space is rising quickly. In November, Regeneron announced $1.47 billion in U.S. sales from Eylea during the third quarter of 2021, and the company is currently testing a high-dose version of its drug in hopes that it can be administered less often. Other companies, such as Bay Area firm Kodiak Sciences, are not far behind. In a December note to investors, stock analysts for investment banking company Cowen acknowledged that Roche’s drug would be the biggest rival to Eylea, though they weren’t sure how that competition would shake out.

“Faricimab should be competitive based on its Phase III data once it reaches the market following a likely approval in January,” they wrote, referring to Vabysmo by its pre-approval name. “However, the bar set by Eylea in terms of physician and patient experience is about as high as it could possibly be, and the early experience for faricimab must be absolutely pristine for it to experience significant uptake.”

Roche looks to compete against a blockbuster with its newly approved vision drug