FDA Approves Genentech’s Bispecific Antibody For Two Leading Causes Of Vision Loss

January 28th, 2022

On January 28, 2022, the FDA approved Vabysmo(faricimab-svoa) for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo is the only injectable eye medicine approved simultaneously in the U.S. for wet AMD and DME, with flexible dosing regimens based on patient need.

News in brief

  • Vabysmo is the first bispecific antibody approved to treat eye conditions.
  • It targets and inhibits angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – two disease pathways linked to a number of vision-threatening retinal conditions.
  • The approval is based on positive results across four Phase III studies in wet AMD and DME.
  • Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with 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. Standard of care for wet AMD and DME typically requires eye injections every one to two months.

Supporting Information

Levi Garraway, M.D., Ph.D.

“Vabysmo provides a new approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously. This is our second FDA approval in ophthalmology in recent months, underscoring our commitment to people living with retinal conditions.”