The agency has approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.
Roche announced on January 31, 2022 that the FDA had 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 related to vision loss by neutralizing angiopoietin-2 and vascular endothelial growth factor-A.
The FDA approval is based on the results of four phase III studies which showed that patients who received the drug at intervals of up to four months had “non-inferior vision gains compared to aflibercept administered every two months during the first year”. Patients with nAMD or DME would receive four monthly treatments and may require additional treatments depending on treatment results. “A second approved treatment regimen for DME involves six monthly loading doses, followed by bimonthly treatment. Some people with nAMD and DME can be treated monthly if needed, although additional efficacy n has not been demonstrated in most people receiving Vabysmo monthly,” the company said in a press release.
“Vabysmo offers a novel approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously,” said Levi Garraway, MD, 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.”