Roche Reports Two-Year Vabysmo Data Showing Sustained Vision Gains in Polypoidal Choroidal Vasculopathy

SALWEEN Study Shows Continued Improvements in Vision and Retinal Health

Roche has announced new two-year results from the Phase IIIb/IV SALWEEN study evaluating Vabysmo (faricimab) in people with polypoidal choroidal vasculopathy (PCV).

The findings were presented at the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress in Australia.

The results showed that patients treated with Vabysmo experienced sustained improvements in vision and retinal health over two years. The treatment also helped control the abnormal blood vessels associated with PCV while allowing many patients to extend the time between treatments.

PCV is a difficult-to-treat subtype of neovascular age-related macular degeneration (nAMD) and is particularly common among Asian populations.

Vision Improved After Two Years of Treatment

The SALWEEN study followed patients for two years to understand how well Vabysmo could control PCV while maintaining vision.

From baseline, patients experienced an average gain of 7.3 letters in best-corrected visual acuity (BCVA) when measured over Weeks 100 to 108.

BCVA is a standard eye test used to measure how clearly a person can see when using the best possible correction.

The study also showed a reduction of 127 micrometers in central subfield thickness (CST) from baseline.

CST is a measurement of retinal thickness. An increase can indicate swelling or fluid in the retina, which can affect vision.

Most Patients Had No Retinal Fluid at Year Two

Another important finding came from the assessment of retinal fluid.

At the two-year mark, 74% of patients had no retinal fluid.

Fluid can build up in the retina when abnormal blood vessels leak. Controlling this fluid is an important part of managing nAMD and PCV because persistent retinal swelling can damage retinal tissue and affect vision.

The results suggest that Vabysmo was able to provide sustained control of retinal disease activity in many patients during the study.

Vabysmo Helped Control Polypoidal Lesions

PCV is characterized by abnormal, polyp-like blood vessel structures.

These lesions can leak fluid or blood and can cause damage to the retina.

The SALWEEN results showed that Vabysmo had a significant effect on these lesions.

By the end of the two-year study:

• 62% of patients achieved complete regression of polypoidal lesions.
• 86% achieved inactivation of polypoidal lesions.

Inactivation means that the abnormal lesions were no longer showing signs of active disease.

Professor Gemmy Cheung of Duke-NUS Medical School and the National University of Singapore said the results showed that dual Ang-2 and VEGF-A inhibition could help change the course of this vision-threatening disease.

More Patients Were Able to Extend Treatment to 20 Weeks

Treatment frequency is an important issue for people receiving injections for retinal diseases.

In the first year of the SALWEEN study, 51% of patients were assigned to a 20-week dosing interval.

By the end of the second year, this had increased to 61%.

This means that more than half of the patients were able to receive Vabysmo with a 20-week interval between treatments under the study's personalised treatment approach.

For patients, longer treatment intervals can mean fewer injections and fewer visits to the clinic.

What Was the SALWEEN Study?

SALWEEN was a Phase IIIb/IV, multicentre, open-label, single-arm clinical study evaluating Vabysmo in Asian patients with PCV.

The study enrolled 135 patients aged 50 years and older.

Participants came from 38 sites across nine Asian markets, including:

• China
• Hong Kong SAR
• India
• Japan
• Malaysia
• Singapore
• South Korea
• Taiwan
• Thailand

Patients initially received four loading doses of Vabysmo 6 mg over a 12-week period.

After the initial treatment period, dosing intervals were adjusted according to each patient's disease response.

Patients could receive treatment every eight, 12 or 16 weeks.

From Weeks 44 to 104, treatment was based on a personalised dosing plan, with intervals extended up to 20 weeks.

The primary endpoint of the study was the change from baseline in BCVA averaged over Weeks 40 to 48.

Why PCV Is Important in Asia

PCV is a subtype of neovascular age-related macular degeneration.

It is particularly common among Asian populations and can represent up to 60% of nAMD cases in this group.

By comparison, PCV accounts for up to around 20% of nAMD cases among people of European descent.

The condition involves abnormal blood vessels developing in the choroid, a thin layer of tissue located between the retina and the white outer layer of the eye.

These abnormal vessels can leak fluid or blood.

When this happens, the retina can become damaged and central vision can be affected.

People with PCV may notice blurred vision or a blind spot in or around the centre of their vision.

PCV Can Lead to Serious Vision Problems

PCV is part of the broader group of conditions known as neovascular or wet age-related macular degeneration.

AMD affects the macula, the part of the eye responsible for sharp central vision.

This type of vision is needed for activities such as reading, recognising faces and seeing details.

In nAMD, abnormal blood vessels grow underneath the macula.

These vessels can leak fluid and blood and may eventually cause scarring or fibrosis.

If the disease is not treated, vision loss can progress quickly.

Around 20 million people worldwide are living with nAMD, and the number is expected to increase as populations age.

How Vabysmo Works

Vabysmo is a bispecific antibody designed to target two signalling pathways involved in retinal diseases.

It blocks angiopoietin-2, or Ang-2, and vascular endothelial growth factor-A, or VEGF-A.

Both pathways are involved in the development and progression of abnormal blood vessels.

VEGF-A can promote the formation of new blood vessels and increase leakage from existing vessels.

Ang-2 can contribute to blood vessel instability and inflammation.

By targeting both pathways, Vabysmo is designed to help stabilise blood vessels and reduce the processes that contribute to retinal damage.

Vabysmo is the first bispecific antibody approved for use in the eye.

Safety Remained Consistent With the Known Profile

Roche reported that Vabysmo was well tolerated in the SALWEEN study.

The safety findings in patients with PCV were consistent with the known safety profile of Vabysmo in nAMD.

The company continues to evaluate Vabysmo across different retinal diseases and patient populations.

Roche Highlights the Durability of the Treatment

Levi Garraway, M.D., Ph.D., Roche's chief medical officer and head of global product development, said the two-year SALWEEN results demonstrate sustained efficacy and durability in people living with PCV.

He also noted that Vabysmo has continued to show efficacy and durability across several high-burden eye diseases since its initial approvals.

For PCV patients, the ability to maintain vision, control retinal fluid and reduce activity in abnormal blood vessels is particularly important.

The possibility of extending treatment intervals also addresses another practical challenge faced by people receiving long-term retinal therapy.

Vabysmo Is Already Approved in Many Countries

Vabysmo has been approved in more than 100 countries, including the United States, Japan, the United Kingdom and the European Union.

It is approved for people with neovascular or wet age-related macular degeneration and diabetic macular edema in these markets.

Vabysmo is also approved in more than 60 countries, including the US, EU and Japan, for macular edema following retinal vein occlusion.

Regulatory reviews by other health authorities are continuing.

Roche Continues to Expand Its Retina Pipeline

The SALWEEN results are part of Roche's wider focus on retinal diseases.

The company is developing treatments aimed at some of the leading causes of vision loss.

Its retina pipeline includes several treatment approaches, including antibodies as well as gene and cell therapies.

These programmes are being developed for conditions such as retinal vascular diseases, diabetic eye diseases, geographic atrophy and other vision-threatening disorders.

Roche is also researching treatments for autoimmune eye conditions, including thyroid eye disease and uveitic macular edema.

The company's approach combines drug discovery, molecular engineering, biomarkers and personalised healthcare to develop treatments for different retinal conditions and patient needs.

About Roche

Roche is a global healthcare company operating across medicines, diagnostics and digital health solutions.

The company focuses on using science and technology to develop new ways to prevent, diagnose and treat diseases.

Its work in ophthalmology includes research into retinal diseases where patients continue to face significant risks of vision loss.

The two-year SALWEEN findings add further clinical evidence for Vabysmo in PCV, particularly in Asian patients, where this subtype of nAMD is more common.