Roche Vabysmo PCV Study data unveiled on August 28, 2026, at the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress in Gold Coast, Australia, show that patients with polypoidal choroidal vasculopathy (PCV) sustained meaningful vision and retinal health gains after two full years of treatment with Vabysmo (faricimab). The Basel-based company (SIX: RO, ROP; OTCQX: RHHBY) said the findings come from the Phase IIIb/IV SALWEEN trial, the first large multicentre study to focus specifically on Vabysmo’s performance in this aggressive, Asia-prevalent form of neovascular age-related macular degeneration (nAMD).
PCV is considered one of the more stubborn subtypes of nAMD, a disease that remains the leading cause of vision loss in people over age 60 worldwide. Because PCV involves abnormal, polyp-like blood vessels beneath the retina, it has historically been harder to control with standard anti-VEGF therapy alone. Roche’s two-year dataset suggests that dual inhibition of angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) can meaningfully change that picture for patients across nine Asian markets.
According to the company, more than 60% of participants treated with Vabysmo showed no remaining signs of polypoidal lesions by the two-year mark, while a majority were also able to move to a less frequent, 20-week treatment schedule. Roche executives framed the results as reinforcing the drug’s position in a competitive retinal disease market that includes rival anti-VEGF and dual-pathway therapies from other major pharmaceutical companies.
“The two-year SALWEEN results demonstrate the sustained efficacy and durability of Vabysmo in people living with PCV, a difficult-to-treat subtype of nAMD that is common in Asia,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, in the company’s release. Garraway added that Vabysmo has continued to show strong efficacy, durability, and a favorable safety profile across a range of high-burden eye diseases since its original approval.
Roche Vabysmo PCV Study: Key Efficacy Findings from SALWEEN
The SALWEEN trial enrolled 135 patients aged 50 and older across 38 sites in nine Asian markets, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan, and Thailand. Patients began with four loading doses of Vabysmo 6 mg over 12 weeks before moving to an individualized maintenance schedule, with dosing intervals extended up to every 20 weeks between weeks 44 and 104 based on disease activity.
Averaged over weeks 100 to 108, patients gained 7.3 letters in best-corrected visual acuity (BCVA) and saw central subfield thickness (CST) decrease by 127 micrometers from baseline, both signs of improved retinal structure and function. By year two, 74% of patients had no detectable retinal fluid, a key marker of disease control in nAMD and PCV. On the vascular abnormalities that define PCV, the study reported complete regression of polypoidal lesions in 62% of eyes and inactivation in 86% of eyes.
Beyond the headline efficacy numbers, the Roche Vabysmo PCV Study also tracked treatment-interval data that may be just as significant for clinicians managing chronic retinal disease. At the end of year one, 51% of SALWEEN patients had reached the extended 20-week dosing interval; by the end of year two, that figure rose to 61%. Roche said Vabysmo was well tolerated throughout the study, with a long-term safety profile consistent with its established use in broader nAMD populations. Professor Gemmy Cheung of Duke-NUS Medical School and the National University of Singapore, an investigator on the trial, said achieving polypoidal lesion inactivation in nearly nine out of ten patients while preserving extended dosing for most represents a shift in how clinicians can approach PCV management.
About Polypoidal Choroidal Vasculopathy and the Broader nAMD Burden
PCV disproportionately affects people of Asian descent, accounting for up to 60% of nAMD cases in Asian populations compared with up to 20% in people of European descent, according to data cited in Roche’s release. The condition is marked by abnormal blood vessels in the choroid, the thin tissue layer between the sclera and the retina, which can leak fluid or blood and cause progressive retinal damage. Patients often notice blurred vision or a blind spot near the center of their visual field in one or both eyes, and early diagnosis is considered important for preserving vision.
Globally, an estimated 20 million people live with nAMD, and that number is expected to grow as populations age, placing sustained pressure on retina specialists and health systems. Data from the Roche Vabysmo PCV Study help quantify how large that burden is specifically within the PCV subgroup, where treatment response has historically varied more than in typical nAMD. The Roche Vabysmo PCV Study adds to a body of evidence that dual Ang-2/VEGF-A inhibition may offer an alternative treatment path for the PCV subgroup, which has not always responded as predictably to single-pathway anti-VEGF agents alone.
How the Roche Vabysmo PCV Study Fits Vabysmo’s Broader Clinical Profile
Vabysmo, known generically as faricimab, is described by Roche as the first bispecific antibody approved for use in the eye. It works by neutralizing both Ang-2 and VEGF-A, two signaling molecules linked to blood vessel instability, abnormal vessel growth, and inflammation in retinal disease. By blocking both pathways at once, the drug is designed to stabilize blood vessels more effectively than therapies that target VEGF-A alone. Investigators involved in the Roche Vabysmo PCV Study have pointed to this dual mechanism as the likely driver behind the high rates of polypoidal lesion inactivation observed in the trial.
Vabysmo’s Regulatory Footprint and Roche’s Ophthalmology Pipeline
Vabysmo already holds approval in more than 100 countries for nAMD and diabetic macular edema, including the United States, Japan, the United Kingdom, and the European Union, and in more than 60 countries for macular edema following retinal vein occlusion (RVO). None of these existing approvals currently carry a PCV-specific label, which is why the Roche Vabysmo PCV Study is being closely watched by retina specialists in Asian markets. Regulatory reviews specific to the PCV data from the Roche Vabysmo PCV Study are ongoing with health authorities outside the SALWEEN trial’s home markets, and Roche has not disclosed a specific timeline for potential label expansion requests tied to PCV.
Roche has positioned ophthalmology as a core focus area within its pharmaceuticals division, describing its retina pipeline as the broadest in the field. That pipeline reportedly spans antibodies as well as gene and cell therapies aimed at retinal vascular disease, diabetic eye disease, geographic atrophy, thyroid eye disease, and uveitic macular edema. Executives have said future readouts across this pipeline, alongside continued longer-term SALWEEN follow-up, will help determine how broadly dual-pathway inhibition gets adopted for PCV and other hard-to-treat retinal conditions. The Roche Vabysmo PCV Study is expected to remain a reference point for that broader pipeline strategy as additional retina data mature over the next several reporting cycles.
What the Roche Vabysmo PCV Study Means for Patients and Investors
For retina specialists, the practical takeaway from the Roche Vabysmo PCV Study is a treatment option that combines durable disease control with materially fewer injections over time, an important consideration given how treatment burden affects patient adherence in chronic eye disease. For Roche, sustained two-year efficacy and safety data in an Asia-heavy indication support continued commercial positioning of Vabysmo against competing anti-VEGF and emerging dual-pathway therapies as the broader nAMD and PCV treatment landscape evolves.
Roche said full SALWEEN trial results will be submitted for peer-reviewed publication, and the company continues to generate real-world and long-term follow-up data on Vabysmo across its approved indications. Publication of the Roche Vabysmo PCV Study in a peer-reviewed journal would give clinicians outside the original nine trial markets a fuller basis for evaluating the therapy in their own PCV patient populations. Investors will likely watch upcoming quarterly disclosures for any commentary tied to the Roche Vabysmo PCV Study and Vabysmo’s revenue trajectory as label discussions in PCV-specific markets progress.
