Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO).
Vabysmo, recognized as the world’s first ophthalmic injectable BsAb, targets both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). It has previously been approved for use in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in China.
The latest approval is supported by the positive results of the global Phase III COMINO study. The study demonstrated that faricimab achieved an average improvement of 16.9 letters in visual acuity and an average reduction of 461.6 μm in central retinal thickness (CST). It also allowed 93.7% of patients to meet the criteria of “no macular edema,” thus achieving the primary endpoint of the study. The 72-week update data indicates that faricimab can extend the treatment interval to 3-4 months, with the visual improvement and disappearance of retinal fluid obtained in the first 24 weeks being maintained until 72 weeks.- Flcube.com
