Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME).
Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2), enhancing vascular stability and providing long-term visual benefits along with an improved quality of life for patients by inhibiting neovascularization. The approval is supported by data from the global Phase III YOSEMITE and RHINE studies, which demonstrated that approximately 80% of diabetic patients with macular edema can be treated with faricimab at intervals of 3-4 months, achieving the same or better treatment outcomes with fewer treatment sessions. Additionally, a one-year study of faricimab in a Chinese DME patient subgroup indicated that 75% of patients in the individualized treatment group had dosing intervals of 12 weeks or more, and 50% had intervals of 16 weeks. The overall safety and tolerability profile of faricimab was found to be consistent with global data.- Flcube.com
