New study shows Roche’s Vabysmo improves vision in Asian patients with a prevalent form of neovascular age-related macular degeneration (nAMD)

• PCV (Polypoidal Choroidal Vasculopathy) is a prevalent form of nAMD in Asian populations, often leading to severe vision loss1

• Interim data from SALWEEN show that patients treated with Vabysmo had improvement in their vision, with an average gain of +7.8 letters – equivalent to reading about one and a half lines more on an eye chart - at 16 weeks.2

• 80% of patients had no fluid in their retina and 51% experienced a complete disappearance of polypoidal lesions (abnormal blood vessels characteristic of PCV), indicating improved retinal health

• Interim results from SALWEEN, a trial which includes PCV patients from nine Asian markets, have been presented at the Asia-Pacific Vitreo-retina Society (APVRS) taking place in Singapore from 22-24 November 2024

SINGAPORE, November 22, 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) shared encouraging 16-week interim data from its ongoing phase 3b/4 SALWEEN trial, showing significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a prevalent form of neovascular age-related macular degeneration (nAMD) in Asian patients.3 The treatment, Vabysmo® (faricimab), is designed to target the underlying causes of this serious eye disease.

The data, presented at the Asia-Pacific Vitreo-retina Society (APVRS) conference in Singapore, revealed that patients treated with Vabysmo showed an average improvement of +7.8 letters in their vision test—equivalent to reading about one and a half lines more on an eye chart—at 16 weeks. Additionally, patients experienced a substantial reduction in retinal swelling, with 80% of patients having no fluid in the retina, and 51% of those with polypoidal lesions, a key characteristic of PCV, saw these abnormal blood vessels completely disappear.2

"PCV has historically been more challenging to treat, with outcomes that are less predictable compared to typical neovascular age-related macular degeneration. 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," said Professor Gemmy Cheung, Head of Retina Research at SERI and Head of the Medical Retina Department at the Singapore National Eye Centre (SNEC).

“Building on the success of the TENAYA and LUCERNE studies, this trial focuses specifically on PCV, offering clinicians valuable insights to tailor treatments for these patients. By addressing key scientific questions—such as how polypoidal lesions respond to faricimab and the role of the Tie 2 pathway—we are advancing our understanding of how best to manage this complex condition," said Professor Cheung.

A subtype of nAMD, PCV primarily impacts the blood vessels in the layer beneath the retina, leading to damage in the cells responsible for vision. This can cause serious vision impairment or even vision loss if left untreated.4

“With nearly two-thirds of global vision loss concentrated in the Asia Pacific, advancing treatments for this region is essential. These early results from the SALWEEN trial are promising and highlight Vabysmo’s potential to significantly improve outcomes for people with PCV," said Ahmed Elhusseiny, Area Head, Asia Pacific, Roche Pharmaceuticals. "As the population ages, the need to address a wider range of eye health challenges in the region is clear. At Roche, we are committed to shaping the future of eye care by developing the most advanced retina treatments, empowering patients across Asia to preserve their vision and lead fuller lives.”

The SALWEEN study, which is being conducted across multiple countries in Asia, including China, Japan and South Korea, involves 135 patients aged 50 years and older. In the first 12 weeks, patients received four monthly loading doses of Vabysmo, with future doses adjusted based on each patient's condition. The final results of this study are expected in 2026.

PCV is a common subtype of neovascular age-related macular degeneration (nAMD) and is particularly prevalent in Asians.3,5 PCV primarily affects the vascular layer of blood vessels in the choroid, resulting in damage to the overlying retina. 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.4

The SALWEEN study [ISRCTN69073386] is an ongoing Phase 3b/4 multi-centre, open-label, single-arm study designed to evaluate the efficacy, safety and durability of Vabysmo (faricimab), a dual angiopoietin-2 and vascular endothelial growth factor-a inhibitor, in patients with polypoidal choroidal vasculopathy (PCV). This study includes 135 patients of 50 years and over from 38 sites across nine markets in Asia, including Mainland China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand.

Patients in the study received four loading doses of Vabysmo 6.0 mg over 12 weeks. After that, their treatment schedule is adjusted based on their progress, with doses given every 8, 12, or 16 weeks. From weeks 44 to 104, patients will follow a personalized treatment plan with doses spaced out as far as every 20 weeks. The primary endpoint is the change from baseline best-corrected visual acuity (BCVA) averaged over weeks 40-48.

Interim data were presented at Asia Pacific Vitreo-retina Society (APVRS) congress in November 2024. Week 16 analyses included change from baseline BCVA and central subfield thickness (CST), proportion of patients with no intra- and subretinal fluid (IRF and SRF), resolution of polypoidal lesions (PL), as assessed by Indocyanine Green Angiography, and safety. From 135 patients enrolled, the study experienced a very low (3.7%) discontinuation rate through to week 16. The final trial results are expected in 2026.6

Roche has a robust Phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X (NCT04777201), an extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and RHONE-X, an extension study of YOSEMITE and RHINE, evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME).7,8 Additionally, the COMINO and BALATON trials evaluated the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.9.10

Roche has also initiated several Phase IV studies, including the ELEVATUM (NCT05224102) study of Vabysmo in underrepresented patient populations with diabetic macular edema, and the POYANG (NCT06176352) study of Vabysmo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia.6,11,12 Roche has also initiated the VOYAGER (NCT05476926) study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.13

Vabysmo is the first bispecific antibody approved for the eye.14,15 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.15,16 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US and Japan, for the treatment of macular edema following retinal vein occlusion.14,17-21 Review by other health authorities is ongoing.

Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments across multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States (US) Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD) that continuously delivers a customised formulation of ranibizumab over a period of months.22,23 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.14-16,19 Vabysmo is approved around the world for people living with nAMD and diabetic macular edema, and in several countries, including the US and Japan, for macular edema following retinal vein occlusion. 14,17-21 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.24

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit

Phone:/ e-mail:

Shilpika Das, e-mail:

Isaac Tan, e-mail:

*Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. All trademarks used or mentioned in this release are protected by law.

M-SG-00001888-10-2024

References

1. Cheung CMG, et al. Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management. Ophthalmology. 2018;125(5):708-724.   

2. Cheung CMG et al. Faricimab for Polypoidal Choroidal Vasculopathy: Week 16 Results From the Phase 3b/4 SALWEEN Trial. [Internet; cited September 2024] Available at:  

3. Singapore National Eye Centre. Translational Asian Age-related macular degeneration Programme (TAAP). [Internet; cited September 2024]. Available from:

4. The Foundation of the American Society of Retina Specialists. Polypoidal Choroidal Vasculopathy. [Internet; cited September 2024]. Available from:

5. Wong, CW et al. Age-related macular degeneration and polypoidal choroidal vasculopathy in Asians.2016 Jul:53:107-139.

6. Lee WK, et al. Design and rationale of the SALWEEN trial: A Phase 3b/4 study of faricimab, a dual angiopoietin-2 and vascular endothelial growth factor-a inhibitor, in patients with polypoidal choroidal vasculopathy. [Internet; cited September 2024]. Available from:

7. Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with nAMD (AVONELLE-X). [Internet; cited September 2024]. Available from:

8. Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with DME (Rhone-X) [Internet; cited September 2024]. Available from: 

9. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO). [Internet; cited September 2024]. Available from:

10. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab (RO6867461) in participants with macular edema secondary to branch retinal vein occlusion (BALATON). [Internet; cited September 2024]. Available from:

11. Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with DME (ELEVATUM). [Internet; cited September 2024]. Available from:

12. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in patients with choroidal neovascularization secondary to pathologic myopia (POYANG). [Internet; cited September 2024]. Available from:  

13. Clinical Trials.gov. A real-world study to gain clinical insights into Roche ophthalmology products (VOYAGER). [Internet; cited September 2024]. Available from:

14. US FDA. Highlights of prescribing information, Vabysmo. 2023 [Internet; cited October 2024]. Available from:

15. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, Phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.

16. Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, Phase III trials. The Lancet. 2022; 399:741-755.

17. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular or ‘wet’ age-related macular degeneration (nAMD) and DME. [Internet; cited September 2024]. Available from:

18. Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with retinal vein occlusion (RVO). [Internet; cited September 2024]. Available from:

19. Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited September 2024]. Available from:

20. European Medicines Agency. Summary of product characteristics, Vabysmo. 2022. [Internet; cited September 2024]. Available from:

21. Roche data on file

22. Holekamp N, et al. Archway randomised Phase III trial of the Port Delivery System with ranibizumab for nAMD. Ophthalmology. 2021.

23. US FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited October 2024]. Available from: 

24. US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited September 2024]. Available from: