Tackling PCV in Asia

Roche’s ongoing SALWEEN trial is seeking to investigate the efficacy, safety, and durability of Vabysmo for patients in Asia suffering from polypoidal choroidal vasculopathy (PCV). We speak with VP, Global Head of Ophthalmology Medical Affairs at the company, Stefan Scheidl, to learn more about how the trial is progressing.

What were the key interim results of the SALWEEN study?
 

The results showed that, at 16 weeks, patients with polypoidal choroidal vasculopathy (PCV) 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. Central Subfield Thickness (CST) also decreased from baseline over 16 weeks by 145 microns, which is clinically relevant.

Additionally, patients experienced a substantial reduction in retinal swelling and fluid resolved rapidly through 16 weeks, with 80 percent of patients having no retinal fluid at week 16. From baseline to week 16, the proportion of patients with: absence of subretinal fluid (SRF) increased from 21 percent to 83 percent; absence of intraretinal fluid (IRF) increased from 81 percent to 95 percent, and absence of SRF and IRF increased from 14 percent to 80 percent. 51 percent of those with polypoidal lesions, a key characteristic of PCV, saw these abnormal blood vessels completely disappear (1).

Can you explain why the trial is looking specifically at Vabysmo treatment for PCV in the Asian population?
 

PCV, a subtype of neovascular age-related macular degeneration (nAMD), is particularly prevalent in Asians, accounting for approximately 50 percent of nAMD cases in this population (2).

In the interim SALWEEN 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 offer a less burdensome treatment schedule for patients, their caregivers, and healthcare systems.

What challenges does PCV present when compared to other forms of nAMD?
 

Historically, PCV has been more challenging to treat than typical nAMD, with less predictable outcomes and challenges in maintaining long-term visual gains. PCV patients often face a high treatment and monitoring burden, especially in regions with limited access to care.

What implications do these findings have for the treatment of nAMD in diverse populations, especially in Asia?
 

SALWEEN is part of a robust clinical development program for Vabysmo and builds on the success of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies (3). All three studies demonstrate rapid and robust visual gains, significant anatomical improvements, and a favorable safety profile. The TENAYA and LUCERNE trials primarily evaluated Vabysmo for nAMD, but also included a small subset of Asian patients with PCV. SALWEEN was implemented with the intention of generating additional evidence on the use of Vabysmo in this patient population.

Asia Pacific has one of the world's fastest-aging populations, with an estimated 1.3 billion people projected to be over 60 by 2050 (4). Additionally, with nearly two-thirds of global vision loss concentrated in the region, advancing treatments is a critical priority (5). The SALWEEN trial highlights Roche’s commitment to addressing these challenges by generating key insights into PCV, enhancing understanding of its clinical benefits, and meeting unmet needs in diverse populations.