MHLW (Japan) approves Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular edema.
Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Vabysmo for Intravitreal Injection 120 mg/ mL (generic name: faricimab) (hereafter, Vabysmo), an anti VEGF/anti Ang-2 bispecific antibody for the treatment of “age-related macular degeneration associated with subfoveal choroidal neovascularization” and “diabetic macular edema (DME).”
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.
Related news and insights
Palisade Bio, Inc. announced the first patient has been dosed in its Phase III study evaluating LB 1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.
bluebird bio, Inc. announced the FDA has approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
Edwards Lifesciences Corporation announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR).