Roche's First-in-Class Ophthalmic Bispecific Antibody Faricimab Receives FDA Filing Acceptance for New Indication in Retinal Vein Occlusion

On May 9, Roche announced that the FDA had accepted the marketing application for a new indication of its ophthalmology bispecific antibody Faricimab, indicated for Retinal Vein Occlusion (RVO). This indication has also been submitted for marketing approval in China. Once approved, Faricimab will become the first bispecific product in the field of retinal diseases that cause blindness.

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 trade 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 mainly 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 a month 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 at week 24 compared to baseline.

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

• BALATON Study: At Week 24, patients in the Vabysmo group showed a vision improvement of 16.9 letters, compared to 17.5 letters in the aflibercept group; central subfield thickness (CST) decreased by 311.4 μm in the Vabysmo group and by 304.4 μm 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 461.6 μm in the Vabysmo group and by 448.8 μm 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 a retinal vein occlusion occurs, blood reflux is obstructed, leading to exudation from retinal vessels, macular edema, and intraretinal hemorrhage, which results in decreased vision. Approximately 28 million adults worldwide (mainly those aged 60 years and above) are affected by RVO. Current treatments primarily include laser therapy, anti-VEGF therapy, and surgical treatment.

Currently, there are four ocular injection formulations globally used for the treatment of RVO: Aflibercept (Regeneron/Bayer), Conbercept (Kanghong Pharmaceuticals), 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. The dosing frequency for wAMD drugs is once every 2 months (Aflibercept) or once every 3 months (Brolucizumab), whereas Faricimab can reduce the dosing frequency to once every 4 months. However, Regeneron/Bayer has developed a new formulation of Aflibercept (8mg), which also reduces 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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