Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.”

Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark, having brought in 957 million Swiss francs ($1.1 billion) in the first six months of 2023.

“We have significant momentum with this drug, and it is rapidly establishing itself as the standard of care,” Graham said of Vabysmo during a press briefing Thursday.

As Vabysmo makes inroads in age-related macular degeneration (AMD) and diabetic macular edema (DME), its rival, Regeneron’s market-leading Eylea, suffered a high-dose rejection at the FDA over manufacturing problems. The two therapies aim to reduce patients’ dosing frequency.

The high-dose Eylea delay gives Roche “the opportunity to continue to make sure that as many retinal specialists as possible are getting experienced with Vabysmo,” Graham said during a separate call with investors. Some patients may be waiting for high-dose Eylea, but that’s not a major trend, she said.

These days, most of Vabysmo’s sales are coming from patients who switched from Eylea. But about a third of Vabysmo takers had never been treated before, a significant increase from the first quarter, Graham said. 

Despite the general positive note, one analyst during Roche’s investor call pointed out that Vabysmo’s quarter-over-quarter sales gain has actually slowed a little. Graham attributed the sales movement to “funky” buying patterns, suggesting that such quarterly fluctuations are not abnormal for a drug that relies on contracting.

To add to Vabysmo’s growth momentum, Roche recently filed the drug for what would become its third indication, retinal vein occlusion. The FDA is slated to decide on that use by December 22, according to Graham.

While Vabysmo is now Roche’s top growth driver, another med in the company’s portfolio is gaining steam with its own blockbuster ambitions. Sales for antibody-drug conjugate Polivy soared 129% in the second quarter, compared with the same period last year, thanks mainly to the FDA’s April approval in first-line diffuse large B-cell lymphoma.

Polivy is now “the easy choice” for treating first-line DLBCL “because it’s their best chance for a cure,” Graham said.

Roche has also heard from the FDA and doctors about a desire to have Polivy as an option in new clinical trials being initiated in newly diagnosed DLBCL.

"That’s a really great indication that people do see this as the next standard of care," Graham said.

Graham’s predecessor, currently Bayer CEO Bill Anderson, had previously put Polivy’s peak sales potential in front-line DLBCL at $2 billion. During Thursday’s earnings call, Graham confirmed that sales target and suggested the drug may eventually generate even more.

Polivy and Vabysmo are part of a group of 20 new medicines Roche has launched since the end of 2015, which now comprise half of its entire pharma sales haul.

For the second quarter, Roche’s pharma division delivered 11 billion Swiss francs of sales, slightly down from 11.7 billion Swiss francs in the first quarter. In two headwinds for the company, Actemra posted no more COVID-related sales this quarter, while COVID antibody Ronapreve sales came to an end earlier this year.