Genentech has released new 2-year data for individuals with diabetic macular edema and wet age-related macular degeneration.
Roche Group’s Genentech subsidiary has announced new 2-year data from its phase 3 studies of Vabysmo (faricimab-svoa) and Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant.
These longer-term results, which will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting on February 12, 2022, from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archway study in wet, or neovascular, age-related macular degeneration (AMD), reinforce the potential to allow for longer times between treatments and fewer eye injections for individuals with these conditions, while still achieving and maintaining vision gains seen with previous standard-of-care injections.
DME and Wet AMD are 2 leading causes of vision loss, together affecting nearly 2 million individuals in the United States, who require treatment with eye injections as often as once a month.
“Results from these 3 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 wet AMD,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a statement. “These 2 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 individuals eligible for extended dosing with Vabysmo could be treated every 4 months at 2 years – a 10-percentage-point increase since the primary analysis at 1 year – while achieving non-inferior vision gains versus aflibercept given every 2 months. Furthermore, nearly 80% of individuals eligible for extended dosing with Vabysmo could be treated every 3 months or longer. In the Archway study, Susvimo allowed 95% of individuals to go 6 months between treatments at 2 years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. Across all 3 studies, with longer follow-up, Vabysmo and Susvimo continued to be generally well tolerated, with favorable benefit-risk profiles. Safety will continue to be monitored closely in the post-market setting.
Vabysmo is the first bispecific antibody for the eye approved by the FDA and the only injectable eye medicine approved for treatments from 1 to 4 months apart in the first year following 4 initial monthly loading doses, based on evaluation of the patient’s anatomy and vision outcomes. Vabysmo is designed to block 2 disease pathways linked to several vision-threatening retinal conditions by neutralizing 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 destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. Although additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel inflammation and leakage more than inhibition of VEGF-A alone.
Susvimo is the first wet AMD 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 is the only FDA-approved treatment that may help people with wet AMD maintain their vision with as few as 2 treatments per year.
New 2-year data for Genentech’s Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss. Genentech. News release. February 10, 2022. Accessed February 11, 2022. https://www.gene.com/media/press-releases/14944/2022-02-10/new-two-year-data-for-genentechs-vabysmo