Few pharmaceutical products have taken the market by storm like Roche’s Vabysmo. In its first full year on the market, the age-related macular degeneration (AMD) treatment racked up sales of 2.4 billion Swiss francs ($2.8 billion). This year through nine months, the bispecific antibody has already topped that figure, even though its momentum has slowed.
After the success Roche has achieved with Vabysmo in Europe and the United States, Asia may present the best opportunity for further growth.
One way to attract customers from Asia would be to expand Vabysmo’s label to treat polypoidal choroidal vasculopathy (PCV), a disorder that leads to vision loss and is a prevalent form of neovascular AMD (nAMD) in Asian populations.
Interim results from a phase 3b/4 trial, testing Vabysmo on PCV patients in nine markets in Asia, suggest that the injected treatment is effective. After 16 weeks, patients in the SALWEEN study showed vision improvement averaging 7.8 letters, which is equivalent to reading roughly one and a half more lines on an eye chart.
Additionally, 51% of patients achieved complete disappearance of polypoidal lesions—the damage to blood vessels that typifies PCV. Another positive result was that 80% of patients had no fluid in their retina. This edge with Vabysmo has been demonstrated in other indications. In general, a drier retina means less swelling and clearer vision.
Roche presented the data Friday morning at the Asia-Pacific Vitreo-retina Society (APVRS) conference in Singapore.
“PCV has historically been more challenging to treat, with outcomes that are less predictable compared to typical neovascular age-related macular degeneration,” Gemmy Cheung, head of the Medical Retina Department at the Singapore National Eye Centre (SNEC), said in a release. “Given that PCV accounts for about half of all nAMD cases in Asian populations, and up to 20% in Caucasian populations, the SALWEEN trial is a significant step forward.”
Final readout for the trial, which includes 135 patients age 50 and older, is expected in 2026. In the first 12 weeks, patients receive four monthly doses of Vabysmo. After that, the dosing is based on the condition of the patients.
Patients with PCV often experience blurred vision or a blind spot in or near the center of their vision in one or both eyes. Early diagnosis and treatment are important to help restore vision and prevent further vision loss.
“With nearly two-thirds of global vision loss concentrated in the Asia Pacific, advancing treatments for this region is essential,” Ahmed Elhusseiny, Roche’s area head, Asia Pacific, said in the release. “As the population ages, the need to address a wider range of eye health challenges in the region is clear.”
As a long-acting treatment for AMD and diabetic macular edema (DME) which was designed to last twice as long as Regeneron and Bayer’s Eylea—four months versus two months—Vabysmo had rapid uptake upon its launch in early 2022. Regeneron and Bayer countered, winning FDA approval of their long-acting version of Eylea in 2023, which has seen improved uptake in the last few quarters.
In the third quarter, worldwide sales of Eylea came in at $2.47 billion, which was a 4% increase year over year. Meanwhile, Roche reported third-quarter sales of Vabysmo at 1 billion Swiss francs ($1.2 billion), which was a 56% YOY boost.