Roche’s Bispecific Antibody Vabysmo Receives FDA Approval for Third Indication: Retinal Vein Occlusion

▎WuXi

Edited by Kant Content Team

Today, Genentech, a subsidiary of Roche, announced that the U.S. FDA has approved its bispecific antibody Vabysmo (faricimab) for the treatment of retinal vein occlusion (RVO). According to the press release,Vabysmo is the first bispecific antibody approved for ocular use, and retinal vein occlusion is the third approved indication for Vabysmo.

Retinal vein occlusion is the second leading cause of vision loss in retinal vascular diseases, with a higher incidence in older patients or those with hypertension, diabetes, high cholesterol, a history of smoking, or other issues affecting vascular health.Retinal Vein Occlusion (RVO) often causes sudden, painless blindness in the affected eye, as the vein blockage restricts normal retinal blood flow, leading to ischemia, hemorrhage, exudation, and retinal swelling (i.e., macular edema). RVO is divided into branch and central types, with the resulting macular edema typically requiring repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs for treatment, which imposes a burden on patients. It is estimated that approximately 16.4 million adults worldwide are affected by this condition.

Vabysmo is a bispecific antibody that simultaneously targets and blocks two key pathogenic pathways—Angiopoietin-2 (Ang-2) and Vascular Endothelial Growth Factor-A (VEGF-A), both of which can disrupt vascular stability., causing blood vessels to leak, increasing inflammation, and thereby driving many retinal diseases that can lead to vision loss. Targeting both pathways simultaneously can have a complementary effect, so Vabysmo is expected to stabilize blood vessels and improve patients' vision. The expression of Ang-2 increases in patients with retinal vein occlusion, and the increase in Ang-2 expression is considered to be associated with the progression of this disease. This therapy was approved by the FDA in January last year for the treatment of wet or neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME).

This FDA approval is mainly based on the positive data from the global BALATON and COMINO Phase 3 clinical trials, which demonstratedMonthly Vabysmo treatment provides early and sustained vision improvement for patients with branch and central retinal vein occlusion.The trial met its primary endpoint at 24 weeks,Compared with the approved drug aflibercept for the treatment of macular edema, it achieved non-inferiority in vision.After 24 weeks of treatment, patients in the Vabysmo group showed a significant reduction in central subfield thickness compared to baseline, indicating that Vabysmo can rapidly reduce retinal fluid.

In both trials, Vabysmo demonstrated good tolerability and consistent safety profiles with previous studies, with the most common adverse event being conjunctival hemorrhage (3%). Consistent safety results were observed across all trial groups.