New Two-year Data for Roche’s Vabysmo and Susvimo Reinforce Potential to Maintain Vision with Fewer Treatments for People with Two Leading Causes of Vision Loss

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new two-year data from its phase III studies of Vabysmo ™ (faricimab) and Susvimo ™ (previously called Port Delivery System with ranibizumab) will be presented at Angiogenesis, Exudation and Degeneration 2022 on 12 February. These longer-term results from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archway study in neovascular or “wet” age-related macular degeneration (nAMD) further reinforce the potential to allow for longer time between treatments and fewer eye injections for people with these conditions, while still achieving and maintaining vision gains seen with previous standard-of-care injections. Neovascular AMD and DME are two leading causes of vision loss, together affecting around 40 million people worldwide, which require treatment with eye injections as often as once a month.

“Results from these three studies reinforce the potential of Vabysmo and Susvimo to redefine standards of care and reduce treatment burden for people living with diabetic macular edema and neovascular AMD,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These two first-of-their-kind treatments are the culmination of over a decade of pioneering research, aiming to better address the needs of people with retinal conditions.”

In the YOSEMITE and RHINE studies, at least 60% of people eligible for extended dosing with Vabysmo could be treated every four months at two years – a 10 percentage point increase since the primary analyses at one year – while achieving non-inferior vision gains versus aflibercept given every two months. Furthermore, nearly 80% of people eligible for extended dosing with Vabysmo could be treated every three months or longer. In the Archway study, Susvimo allowed 95% of people to go six months between treatments at two years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. Across all three studies, with longer follow-up, Vabysmo and Susvimo continued to be generally well-tolerated, with favourable benefit-risk profiles. Safety will continue to be monitored closely in the post-market setting.

Vabysmo^TM (faricimab-svoa) is the first bispecific antibody for the eye approved by the U.S. Food and Drug Administration (FDA), and the only injectable eye medicine approved for treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation. While additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilising vessels and thereby reducing vessel leakage and inflammation more than inhibition of VEGF-A alone.

Susvimo is the first nAMD treatment in 15 years to provide an alternative to standard-of-care eye injections. By continuously delivering medicine into the eye through a refillable implant, Susvimo^TM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is the only FDA-approved treatment that may help people with nAMD maintain their vision with as few as two treatments per year.