Roche's Ophthalmic Bispecific Antibody Faricimab Approved in China for New Indication in BRVO-Related Macular Edema

▎WuXi AppTec Content Team Report

On April 30, Roche（Roche）Announced that the National Medical Products Administration (NMPA) of China has officially approved its ophthalmic bispecific antibody injection.FaricimabA new indication application,For the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)According to the Roche press release, this is the third indication for faricimab approved in China, following diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).

Retinal Vein Occlusion (RVO) is a retinal vascular disease caused by partial or complete obstruction of the retinal vein due to various reasons, leading to impaired blood reflux in the retinal venous system, and subsequently manifesting as retinal vein dilation and retinal hemorrhage. Based on the location of the vascular obstruction, it can be divided into two types: Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO). Among them,Macular edema is the most common complication of RVO and one of the main reasons for vision loss in patients.

In recent years, many preclinical studies have shown that Ang-2 is statistically significantly elevated in RVO patients, suggesting that the disease progression of RVO is jointly driven by VEGF and Ang-2.Faricimab is an innovative bispecific antibody specifically designed for intravitreal injection, which can simultaneously target and inhibit the key pathogenic factors Ang-2 and VEGF-A that cause various retinal diseases., based on the original inhibition of new blood vessel formation, simultaneously enhance vascular stability and reduce abnormal vascular leakage.

Image Source: 123RF

According to the Roche press release, the approval of faricimab for this new indication was primarily based on the positive results from the first part (up to Week 24) of the global Phase 3 clinical study BALATON. At the 20th Annual Angiogenesis Meeting held in February 2023, Roche reported the interim results of this study. The study data showed,Patients in the Faricimab group achieved a 16.9-letter improvement in vision, a 311.4μm reduction in central subfield retinal thickness (CST), and 95.3% of patients were free of macular edema., the study met its primary endpoint.

In February 2024, Roche announced the latest 72-week data from this study. Compared with the previous single-pathway or conventional treatments with intervals of 1 to 2 months,Nearly 60% of BALATON study participants receiving faricimab treatment can extend the treatment interval to 3-4 months.. At the same time, the visual acuity improvement and regression of intraretinal fluid obtained within the first 24 weeks can be maintained up to 72 weeks. In addition, the overall safety and tolerability data of faricimab in the BALATON study were consistent with previous studies.