Roche Submits New Indication Application in China for First-in-Class Ophthalmic Bispecific Antibody Faricimab

On April 11, the CDE website showed that Roche's ophthalmology bispecific antibody Faricimab had submitted a new indication for marketing authorization in China. Based on clinical trial registrations, the indication is presumed to be macular edema secondary to retinal vein occlusion (MEfRVO).

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 August 2022, Roche also submitted an application in China for the marketing approval of this product for the treatment of DME and wAMD.

This new indication application is primarily based on the positive results of two global Phase III studies (BALATON and COMINO). BALATON and COMINO enrolled 553 and 729 patients, respectively, aiming to evaluate the efficacy and safety of Vabysmo (6mg, once monthly for the first 20 weeks) compared with aflibercept (2mg, once every two months) in treating macular edema secondary to retinal vein occlusion (RVO). After receiving 20 weeks of treatment (the first part of the study), patients in the experimental group continued to receive personalized treatment interval (PTI) regimens from weeks 24 to 72 (the second part of the study). The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) score from baseline at week 24.

Studies show that, compared with the aflibercept group, patients in the Vabysmo group experienced continuous improvement in vision. Specifically:

• BALATON Study: At Week 24, patients in the Vabysmo group showed a 16.9-letter improvement in vision, compared to a 17.5-letter improvement in the aflibercept group; central subfield thickness (CST) decreased by 311.4μm in the Vabysmo group and by 304.4μm in the aflibercept group; 34% of patients in the Vabysmo group had no retinal vascular leakage, compared to 21% in the aflibercept group.

• COMINO Study: At Week 24, patients in the Vabysmo group showed a visual acuity improvement of 16.9 letters, compared to 17.3 letters in the aflibercept group; central subfield thickness (CST) decreased by 461.6μm in the Vabysmo group and by 448.8μm in the aflibercept group; 44% of patients in the Vabysmo group had no retinal vascular leakage, compared to 30% in the aflibercept group.

RVO is the second most common cause of blindness. Based on the location of vascular occlusion, it can be divided into two types: branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), with the former accounting for over 80%. After the retinal vein becomes obstructed, blood reflux is impeded, leading to exudation from retinal vessels, macular edema, and intraretinal hemorrhage, causing vision loss. Approximately 28 million adults worldwide (mainly those aged 60 and above) are affected by RVO. Current treatments mainly include laser therapy, anti-VEGF therapy, and surgical treatment.

Currently, there are four ocular injection formulations globally used for treating MEfRVO: Aflibercept (Regeneron/Bayer), Conbercept (Kanghong Pharma), Ranibizumab (Roche/Novartis), and Ozurdex (AbbVie). Except for Ozurdex, all are VEGF/VEGFR-targeted drugs.

According to Roche's 2022 financial report, the annual sales of faricimab reached 591 million Swiss francs (approximately 619 million US dollars based on the average exchange rate last year). Such impressive sales performance is closely related to its remarkable efficacy. Previously, treatments such as aflibercept (2mg), ranibizumab, and brolucizumab could only maintain the medication frequency for wAMD patients at a maximum of once every 3 months. However, faricimab can reduce the injection frequency to once every 4 months. Nonetheless, Regeneron/Bayer has developed a new specification of aflibercept (8mg), which can also reduce the injection frequency to once every 4 months (see: ).

Moreover, KSI-301, a novel conjugated drug developed by Kodiak, could be a strong competitor to Vabysmo, as it may extend the treatment interval to once every 6 months. A Phase III study has already been completed (see: ).

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