OR WAIT null SECS
The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.
Roche announced on Jan. 31, 2022 that FDA approved Vabysmo (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The bispecific antibody targets and inhibits two disease pathways that are linked to vision loss by neutralizing angiopoietin-2 and vascular endothelial growth factor-A.
The FDA approval is based on results from four Phase III studies that showed patients given the drug at intervals up to four months had “non-inferior vision gains versus aflibercept given every two months in the first year.” Patients with either nAMD or DME would receive four monthly treatments and may need additional treatments based on treatment outcomes. “A second approved treatment regimen for DME involves six monthly loading doses, followed by treatment every two months. Some people with nAMD and DME may be treated monthly if needed, although additional efficacy was not demonstrated in most people given Vabysmo every month,” the company stated in a press release.
“Vabysmo provides a new approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously,” said Levi Garraway, M.D., PhD, Roche’s Chief Medical Officer and Head of Global Product Development, in the press release. “This is our second FDA approval in ophthalmology in recent months, underscoring our commitment to people living with retinal conditions.”