Vabysmo Demonstrates Sustained Two-Year Results in a Difficult-to-Treat Form of Neovascular Age-Related Macular Degeneration – Roche

Roche announced new two-year data from the Phase IIIb/IV SALWEEN study of Vabysmo (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe sub-type of neovascular age-related macular degeneration (nAMD), the leading cause of vision loss in people over the age of 60.

“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. 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.” – Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

“PCV is an aggressive subtype of nAMD that accounts for up to 60% of cases in Asian populations — a burden that will only grow as the population ages. These 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.” – Professor Gemmy Cheung, MBBS, FRCOphth, MD, PhD, Duke-NUS Medical School, National University of Singapore.

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.