Vabysmo is the first bispecific antibody in
'I'm very pleased to have obtained approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. Treatment with Vabysmo is expected to improve and maintain vision in patients with RVO, a disease that can severely affect vision and lead to blindness. We will continue to provide information on the proper use of Vabysmo in order to contribute to the treatment of patients with macular edema associated with RVO,' said Chugai's President and CEO, Dr.
This approval is based on the results of the BALATON and COMINO studies for branch retinal vein occlusion and central retinal or hemiretinal vein occlusion, respectively. Both are global phase III clinical studies, and Chugai participated in both studies from
Approval Information Newly added description
Indications: Macular edema associated with retinal vein occlusion
Dosage and administrations: 6 mg (0.05 mL) of faricimab (genetical recombination) is administered by intravitreal injection once every 4 weeks or more.
BALATON and COMINO studies
New phase III data show Roche's Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO) (Press release by Roche issued on
About Vabysmo
Vabysmo is the first bispecific antibody approved in the ophthalmology field.1,2 It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation.3,4 By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.3,4 Vabysmo is approved in more than 90 countries around the world, including
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal vascular diseases.8 It affects an estimated 28 million adults globally, mainly those aged 60 or older, an estimated 1.66 million adults in
Contact:
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Email: pr@chugai-pharm.co.jp
Tel: +81-3-3273-0554
Email: ir@chugai-pharm.co.jp
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