MHLW (Japan) approves Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular edema.

Age-related macular degeneration associated with subfoveal choroidal neovascularization is generally known as neovascular age-related macular degeneration (nAMD).

“Vabysmo is the first bispecific antibody in ophthalmology. This approval marks a full-scale entry into the ophthalmology field for Chugai. Vabysmo is expected to improve vision loss and reduce treatment burden by potentially offering a 16-week dosing interval.

nAMD is a disease in which age-related choroidal neovascularization grows under the retina, causing leakage of fluid and blood, resulting in retinal edema and fluid retention that leads to visual impairment. It is one of the leading causes of vision loss in people over the age of 60 worldwide, with an estimated 880,000 patients in Japan. DME is one of the complications of diabetic retinopathy and is estimated to affect more than 710,000 people in Japan. Leakage of plasma components from blood vessels in the retina causes edema in the macula, resulting in visual impairment and sometimes vision loss.

Vabysmo is designed to inhibit two distinct pathways involved in many retinal diseases by blocking the actions of vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). This approval is based on the results from four global phase III clinical trials (DME: YOSEMITE and RHINE studies, nAMD: TENAYA and LUCERNE studies). These trials demonstrated non-inferiority of Vabysmo to an existing drug (aflibercept) and met their their primary endpoints. In addition, for the first time in a phase III clinical trial of an intravitreal injection, Vabysmo achieved a treatment duration of up to 16 weeks interval.