Roche's Ophthalmic Bispecific Antibody Faricimab Gains New Indication Approval in China for Macular Edema Following Retinal Vein Occlusion

On April 30, the website of the National Medical Products Administration (NMPA) showed,Roche's ophthalmology bispecific antibody faricimab receives approval for new indication in China, speculated to be macular edema secondary to retinal vein occlusion.

Faricimab is a bispecific monoclonal antibody developed by Roche that targets angiopoietin-2 (Ang2) and vascular endothelial growth factor A (VEGFA). In January 2022, faricimab was approved for the first time in the United States under the brand name Vabysmo for the treatment of diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). In October 2023, it received FDA approval for a new indication—macular edema secondary to retinal vein occlusion (RVO).Faricimab was officially approved for marketing in China in December 2023 for the treatment of diabetic macular edema, with the trade name Lucentis. In early January 2024, faricimab was again approved for a new indication for the treatment of neovascular age-related macular degeneration.

Because its efficacy rivals that of aflibercept 2mg and it achieves a lower dosing frequency of once every four months, Vabysmo has experienced extremely rapid growth since its launch. In its first full commercial year in 2023, sales skyrocketed 324% to $2.634 billion. In the first quarter of 2024, its sales increased by 108% year-on-year, reaching 847 million Swiss francs ($923 million), making it one of Roche's most outstanding new products.

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