Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in neovascular or ‘wet’ age-related macular degeneration (nAMD), a leading cause of vision loss.1 In the single-arm SALWEEN study, Vabysmo showed clinically meaningful vision gains and retinal drying over one year in polypoidal choroidal vasculopathy (PCV), a vision-threatening subtype of nAMD that is especially common in Asia.2
“The robust SALWEEN findings in PCV highlight Vabysmo’s potential to deliver clinically meaningful improvements and help mitigate vision loss,” said Professor Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “Alongside the long-term AVONELLE-X results in nAMD, these findings support our mission to develop and deliver impactful medicines for people with difficult-to-treat eye diseases.”
In new one-year data from the single-arm, open-label Phase IIIb/IV SALWEEN study of Vabysmo for the treatment of people with PCV in Asia, patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44 and 48.2 At year one, more than 50% of patients were assigned to extended five-month dosing. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with these lesions completely resolving in more than 60% of patients and inactivation of polypoidal lesions in the majority (86%) of eyes.2 Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD.2
after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months”
The AVONELLE-X study was a two-year open label extension of the two-year Phase III TENAYA and LUCERNE studies of Vabysmo in nAMD.1 Vision remained stable throughout the two years of AVONELLE-X and anatomic improvement from the parent trials were sustained through AVONELLE-X.1 Results showed that after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months, reinforcing the results seen in TENAYA and LUCERNE. Vabysmo was well tolerated, and safety data were consistent with its known safety profile in nAMD.1
To date, Vabysmo is approved in more than 100 countries for nAMD and diabetic macular oedema (DMO), and in more than 60 countries for macular oedema following retinal vein occlusion (RVO). More than eight million doses of Vabysmo have been distributed globally since its initial US approval in 2022.3-8
About AVONELLE-X
AVONELLE-X (NCT04777201) was an open label multicentre two-year extension study of Vabysmo in 1,029 patients with nAMD who completed one of the two Phase III studies, TENAYA(NCT03823287) or LUCERNE (NCT03823300).1
Patients in TENAYA and LUCERNE were treated with either 6 mg Vabysmo or 2 mg aflibercept. During AVONELLE-X, all patients were treated with Vabysmo on a treat-and-extend regimen, where the time between Vabysmo treatments could be adjusted based on retinal fluid levels and visual acuity.
About SALWEEN
SALWEEN was a Phase IIIb/IV multicentre, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV.2 It enrolled 135 patients aged 50 years and over from 38 sites across nine markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients received four loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every eight, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalised treatment plan with doses spaced out as far as every 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48.
References
- Khanani et al. Four-year outcomes of Faricimab in nAMD: Safety and efficacy results from the AVONELLE-X long-term extension trial – 4-7 September, EURETINA 2025.
- Lai et al. Faricimab for polypoidal choroidal vasculopathy: 1-year results from the phase IIIb/4 SALWEEN trial. EURETINA. September 4-7, 2025
- United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. Available from: accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf [accessed August 2025].
- Medicines and healthcare products regulatory agency approves faricimab through international work-sharing initiative. Available from: gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative [accessed August 2025].
- European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. Available from: ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf [accessed August 2025].
- Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. Available from: chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html [accessed August 2025].
- Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. Available from: chugai-pharm.co.jp/english/news/detail/20220328160002_909.html [accessed August 2025].
- Roche data on file.
