08 September 2025 | Monday | News
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Roche announced one-year results from the Phase IIIb/IV SALWEEN study of Vabysmo® (faricimab) in polypoidal choroidal vasculopathy (PCV); a subtype and difficult to treat form of neovascular or “wet” age-related macular degeneration. The findings confirm that Vabysmo delivers robust efficacy, high durability and consistent safety in patients with this vision-threatening condition, reinforcing its potential to address one of the most pressing causes of vision loss in Asia. The data will be presented at the EURETINA 2025 Congress in Paris, France.
At one year, patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44 and 48. This corresponds to nearly two additional lines on a standard eye chart. Importantly, 61 percent achieved complete regression of polypoidal lesions and 86 percent achieved polypoidal lesion inactivation, findings that are expected to lower the likelihood of retinal bleeding and vision loss.
Treatment durability was also demonstrated: more than 50 percent of patients were assigned to extended five-month dosing at the one-year mark, reducing the number of injections needed while maintaining vision. This reduced treatment frequency may help lessen the burden of ongoing injections on patients and families, while supporting more sustainable delivery of care.
“The SALWEEN one-year results are very encouraging for both physicians and patients,” said Professor Timothy Lai, Clinical Professor (Honorary), Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong." Treatment with faricimab led to rapid and robust improvements in vision, with over 60 percent of patients achieving complete regression of polypoidal lesions at one year, an outcome unprecedented with anti-VEGF monotherapy in this condition. These results, together with the fact that more than half of patients could be assigned to nearly five months for the next injection, provide real confidence that we can improve patients’ vision while easing the burden of frequent treatment. For people living with PCV, which is particularly common in Asia, this combination of disease control, extended durability and meaningful impact on daily life is highly significant.”
“The SALWEEN results highlight how innovation can bring meaningful change where it is needed most,” said Ahmed Elhusseiny, Area Head, Asia Pacific, Roche Pharmaceuticals. “PCV is a leading cause of vision loss in Asia, and the one-year findings reinforce Vabysmo’s potential to provide meaningful improvements and help protect against vision loss over time. Fewer injections can mean less disruption for patients and families, and more sustainable care for healthcare systems. Together, these advances show how science can deliver lasting impact across the region.”
SALWEEN is an ongoing study, which is being conducted across multiple countries in Asia, including China, Japan and South Korea. It involves 135 patients aged 50 years and older. Vabysmo was well tolerated and its safety profile was consistent with that observed in other global faricimab trials.
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