Roche Announces FDA Approval of Vabysmo for Diabetic Macular Edema with Extended Dosing Intervals

Roche today announced that the FDA has approved Vabysmo (faricimab-svoa) for the treatment of diabetic macular edema (DME). Vabysmo is the first bispecific antibody approved for an eye condition, targeting both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). In the Phase 3 YOSEMITE and RHINE trials, Vabysmo demonstrated non-inferior visual acuity gains compared to aflibercept with the potential for up to 16-week dosing intervals. Approximately 45% of patients were able to extend to 16-week dosing intervals in the second year of treatment. This extended dosing schedule may reduce the treatment burden for patients with DME.