One-year Vabysmo data show improved vision, with more than half of participants going longer between treatments

• One-year SALWEEN results demonstrate robust efficacy, extended durability and consistent safety in patients with polypoidal choroidal vasculopathy (PCV), a leading cause of vision loss in Asia.1

• Patients achieved a mean improvement of +8.9 letters in best-corrected visual acuity (BCVA), equivalent to nearly two additional lines on a standard eye chart, with sustained reductions in retinal swelling over one year.1

• High rates of complete polypoidal lesion regression (61 percent) and polypoidal lesion inactivation (86 percent) were observed, findings that are expected to lower the likelihood of retinal bleeding and vision loss.1

• At one year, over 50 percent of patients were assigned to extended five-month dosing, reducing the number of injections needed while maintaining vision.1

Singapore, 5 September 2025 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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.1

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.1

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.1

“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.1

About polypoidal choroidal vasculopathy

Polypoidal choroidal vasculopathy (PCV) is a subtype of nAMD that is more prevalent in people of Asian or African descent than European descent. It accounts for up to 60% of nAMD cases in people of Asian descent, and up to 20% in people of European descent.2 Due to a rapidly ageing population, Asia is projected to have a higher burden of AMD than all other regions combined by 2050.3

PCV is characterised by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera (the whites of the eyes) and the retina. These abnormal vessels can leak fluid or blood, leading to retinal damage and vision loss.2,4,5 People with PCV often experience blurred vision or a blind spot in or near the centre of their vision in one or both eyes.5,6 Early diagnosis and treatment are important to help restore vision and prevent further vision loss.4,7

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. nAMD is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.8-10 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.10 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.8, 11,12

About SALWEEN¹

SALWEEN is a Phase IIIb/IV multicentre, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. 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.

About Vabysmo® (faricimab)

Vabysmo is the first bispecific antibody approved for the eye.13-15 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 (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).13,14,17-20 Review by other health authorities is ongoing.

About Roche in Ophthalmology

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 innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and 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 Food and Drug Administration-approved refillable eye implant for nAMD that continuously delivers a customised formulation of ranibizumab over a period of months.21 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.13 Vabysmo is approved around the world for people living with nAMD, DME and macular edema following RVO.13,17 Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.22

About Roche

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.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 

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 www.roche.com.

For any media inquiries related to Roche corporate topics, please contact Roche Group Media Relations:

Phone: +41 61 688 8888 / e-mail: [email protected]

For topics related to the Asia Pacific region, please contact:

Shilpika Das, e-mail: [email protected]