Roche Vabysmo shows sustained two-year data in PCV subtype of nAMD
Roche has presented two-year data from the Phase IIIb/IV SALWEEN study of Vabysmo (faricimab) in polypoidal choroidal vasculopathy (PCV), an aggressive subtype of neovascular age-related macular degeneration that is disproportionately prevalent in Asian populations. The results were disclosed at the 19th Asia-Pacific Vitreo-retina Society Congress in Gold Coast, Australia on 28 August 2026.
PCV accounts for up to 60% of nAMD cases in people of Asian descent, compared with around 20% in those of European descent, making it a significant unmet need in rapidly ageing Asian markets. The SALWEEN study enrolled 135 patients aged 50 and over across 38 sites in nine Asian markets, including China, Japan, Singapore, South Korea and India.
Clinical results
By weeks 100–108, patients showed a mean gain of 7.3 letters in best-corrected visual acuity and a reduction of 127 µm in central subfield thickness from baseline. At the two-year mark, 74% of patients had no detectable retinal fluid. Complete regression of polypoidal lesions was recorded in 62% of eyes, while inactivation was achieved in 86%, a figure cited by the study investigators as clinically meaningful given the haemorrhagic and exudative nature of PCV.
The dosing-interval data are also commercially relevant. At the end of year one, 51% of patients were assigned to the extended 20-week interval; by year two that proportion had risen to 61%. Fewer injections per year is a key competitive differentiator in the anti-VEGF ophthalmology market, where treatment burden is a well-documented reason for suboptimal real-world outcomes.
Professor Gemmy Cheung of Duke-NUS Medical School said the results show that dual Ang-2/VEGF-A inhibition can "change the trajectory of this vision-threatening disease," adding that achieving polypoidal lesion inactivation in nearly nine out of ten patients while maintaining extended dosing intervals "means Vabysmo can provide disease control while also drastically reducing the treatment burden."
Roche reported that the safety profile was consistent with faricimab's established profile across nAMD and diabetic macular oedema indications, with no new signals identified at the two-year timepoint.
Market context
Vabysmo is the first bispecific antibody approved in ophthalmology, targeting both Ang-2 and VEGF-A. It is approved in more than 100 countries for wet AMD and diabetic macular oedema, and in more than 60 countries for macular oedema following retinal vein occlusion. Its principal competitor in the anti-VEGF retinal space is Regeneron and Bayer's aflibercept (Eylea), with high-dose aflibercept formulations approved in recent years specifically to extend dosing intervals. Novartis's brolucizumab (Beovu) also competes, though its uptake has been constrained by safety concerns around intraocular inflammation identified post-launch.
The SALWEEN data add to a growing body of evidence supporting faricimab's durability, a proposition that Roche has consistently emphasised across its retinal programme. For Asia-Pacific markets specifically, demonstrating efficacy in PCV rather than extrapolating from predominantly Western nAMD populations addresses a gap that payers and clinical guidelines in the region have historically flagged. Roche's majority ownership of Chugai Pharmaceutical gives it a strong commercial infrastructure in Japan, one of the key markets in which PCV prevalence is well documented.
Near-term attention will focus on whether these Phase IIIb/IV results are sufficient to support label updates or revised reimbursement submissions in key Asian markets, and on how health technology assessment bodies weigh the extended dosing interval data in cost-effectiveness modelling.