Positive Two-Year Data for PCV

PCV is a severe sub-type of neovascular age-related macular degeneration (nAMD), the leading cause of vision loss in people over the age of 60.^1-3 It is more prevalent in people of Asian descent, accounting for up to 60% of nAMD cases in this population and up to 20% in people of European descent.²

“The two-year SALWEEN results demonstrate the sustained efficacy and durability of Vabysmo in people living with PCV, a difficult-to-treat subtype of nAMD that is common in Asia,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Since its initial approval, Vabysmo continues to demonstrate strong efficacy, durability and a favourable safety profile in treating a range of high-burden eye diseases.”

Professor Gemmy Cheung, from Duke-NUS Medical School and the National University of Singapore, said the two-year results “show that dual Ang-2/VEGF-A inhibition can change the trajectory of this vision-threatening disease”.

“Achieving polypoidal lesion inactivation in nearly nine out of 10 patients, while allowing most to maintain a 20-week dosing interval, means Vabysmo can provide disease control while also drastically reducing the treatment burden,” said Prof Cheung.

Achieving polypoidal lesion inactivation in nearly nine out of 10 patients, while allowing most to maintain a 20-week dosing interval, means Vabysmo can provide disease control while also drastically reducing the treatment burden

PCV is characterised by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera 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

SALWEEN was 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 treatment intervals extended up to 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48.¹

The study showed that patients experienced a gain of 7.3 letters in best-corrected visual acuity (BCVA) and a reduction of 127 µm in central subfield thickness (CST) from baseline averaged over weeks 100–108. At year two, 74% of patients had no retinal fluid. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with complete regression (62%) and inactivation (86%) of polypoidal lesions in the majority of eyes. At the end of the first year, 51% of patients were assigned to extended 20-week dosing, which increased to 61% by the end of year two. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD.¹