In an exclusive conversation with BioPharma APAC, Stefan Scheidl, VP and Global Head of Ophthalmology Medical Affairs at Roche, delves into the groundbreaking interim findings from the SALWEEN trial. With significant improvements in vision and disease control for patients with polypoidal choroidal vasculopathy (PCV), Vabysmo (faricimab) emerges as a promising solution to the challenges of this prevalent condition in Asia. Scheidl shares his perspectives on how these results compare to existing therapies, address unmet patient needs, and set the stage for a new standard of care in ophthalmology.

Can you elaborate on the significance of the +7.8 letters improvement observed in the SALWEEN trial? How does this compare to other treatments for PCV or neovascular age-related macular degeneration (nAMD)?

The interim results from the SALWEEN trial showed that at 16 weeks, patients treated with Vabysmo (faricimab) experienced an average improvement of +7.8 letters in best-corrected visual acuity (BCVA), equivalent to reading about one and a half additional lines on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.

These results are particularly significant for Asian patients with PCV, as they demonstrated not only improved vision but also the disappearance and inactivation of the majority of polypoidal lesions at 16 weeks—a meaningful advancement in addressing a critical unmet need. Overall, faricimab demonstrated a rapid disease control in a majority of patients, who may further need fewer treatments. With the potential for fewer injections over time, Vabysmo could provide a less burdensome treatment schedule for patients, caregivers, and healthcare systems, while maintaining improvements in vision and anatomy.

SALWEEN is a single-arm study with no active comparator. Thus, there is no direct comparison between Vabysmo and other treatments.

What makes Vabysmo (faricimab) distinct from other available treatments for PCV, and how does it address the unmet needs of patients in Asia?

PCV, a subtype of neovascular age-related macular degeneration (nAMD), is particularly prevalent in Asians, accounting for approximately 50% of nAMD cases in this population. Patients often face a high treatment and monitoring burden, especially in regions with limited access to care. Historically, PCV has been more challenging to treat than typical nAMD, with less predictable outcomes and challenges in maintaining long-term visual gains.

The interim results from the SALWEEN trial, presented at the Asia-Pacific Vitreo-retina Society (APVRS) conference in Singapore, highlight Vabysmo’s potential to significantly improve outcomes for PCV patients. These findings underscore its promise in addressing the pronounced challenges of PCV in Asia.

Vabysmo is the first bispecific antibody approved for the eye, targeting and inhibiting two signaling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). With its differentiated mode of action, Vabysmo requires fewer eye injections over time, effectively reducing the treatment burden for both patients and their caregivers.

With 80% of patients showing no fluid in the retina and 51% achieving complete disappearance of polypoidal lesions, how might these results influence the standard of care for PCV in the region?

PCV primarily affects the vascular layer of blood vessels in the choroid, resulting in damage to the overlying retina. The abnormal vessels in PCV are distinctive, appearing as orange bulges or resembling a ‘bunch of grapes’ or a ‘string of pearls’. These abnormal blood vessels in the choroid can leak fluid or blood into or under the retina, causing scarring or atrophy of retinal tissue, which presents itself as vision loss for those affected.

In the SALWEEN trial, we saw that patients experienced a substantial reduction in retinal swelling. Fluid resolved rapidly through 16 weeks, with 80% of patients having no retinal fluid at week 16. From baseline to week 16, the proportion of patients with: absence of SRF increased from 21% to 83%; absence of IRF increased from 81% to 95% and absence of SRF and IRF increased from 14% to 80%. Additionally, 51% of those with polypoidal lesions, a key characteristic of PCV, saw these abnormal blood vessels completely disappear. These results are encouraging and highlight Vabysmo’s potential to significantly improve outcomes for people with PCV.

Vabysmo (faricimab), with its dual inhibition of both Ang-2 and VEGF-A, may offer a more comprehensive approach to managing PCV. By improving vascular stability, faricimab could provide greater disease control leading to improved clinical outcomes in patients with PCV. With 80% of patients showing no fluid in the retina and 51% and 86% achieving complete disappearance and inactivation of polypoidal lesions, respectively, Vabysmo is potentially setting a new benchmark in the treatment of PCV.

Given the prevalence of PCV in Asian populations, how is Roche addressing the barriers to accessibility and affordability of Vabysmo in these markets?

Vabysmo is already available across several APAC markets including New Zealand, Australia, China, Taiwan, Hong Kong, South Korea, Vietnam, Indonesia, Singapore, Philippines, Malaysia, Thailand, Bangladesh, India and Japan for nAMD and DME.

We are committed to partnering with governments, regulatory and reimbursement authorities and non-governmental stakeholders to identify solutions that will help ensure our medicines are accessible for people who need them.

Could you discuss Roche’s broader pipeline in ophthalmology and how it complements the findings from the SALWEEN trial, particularly in addressing vision-threatening conditions in Asia?

With nearly two-thirds of global vision loss concentrated in the Asia Pacific, advancing treatments for this region is essential. 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 patients. We have the broadest 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.

SALWEEN is part of a robust clinical development programme for Vabysmo and builds on the success of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies. This study focuses specifically on PCV patients and is being conducted across multiple regions in Asia, including China, Japan, and South Korea. SALWEEN offers valuable insights for clinicians to tailor treatments for these patients. It also addresses key scientific questions which help to advance understanding of how to manage PCV, a condition which has historically been more difficult to treat than other types of nAMD.

What are the key takeaways from the interim results for healthcare professionals and caregivers, and what future milestones can we expect from the SALWEEN trial?

In the interim results we saw that Asian patients living with PCV experienced improvement in vision, as well as the disappearance of the majority of the polypoidal lesions at 16 weeks, which is a significant step forward in addressing an urgent need for patients, and ultimately improving patients’ quality of life. With the potential to require fewer injections over time, while also improving and maintaining vision and anatomy, Vabysmo could also offer a less burdensome treatment schedule for patients, their caregivers, and healthcare systems.

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, in PCV. This study aims to generate deeper scientific evidence and insights into the use of Vabysmo for PCV. 

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 personalised treatment plan with doses spaced out as far as every 20 weeks. The primary endpoint is the change from BCVA averaged over weeks 40-48.

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, as assessed by Indocyanine Green Angiography, and safety. From 135 patients enrolled, the study experienced a very low (0.7%) discontinuation rate through to week 16. The final trial results are expected in 2026.

• References:

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