Roche's Faricimab (Vabysmo®) Becomes First Dual-Target Ocular Biologic Approved in China for Diabetic Macular Edema

ShanghaiDecember 18, 2023PR Newswire -- Roche announced today that the National Medical Products Administration of China has officially approved the ophthalmic injection bispecific antibody Faricimab (trade name: RoVisia).^®，Vabysmo^®) for the treatment of diabetic macular edema (DME). Faricimab is the world's first dual-pathway innovative retinal treatment drug.^[2]Its dual mechanism of action, which simultaneously targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), along with its sustained advantages, can inhibit neovascularization while enhancing vascular stability, improving long-term visual outcomes and enhancing patients' quality of life.

Vision impairment is a globally significant health issue, affecting the daily lives of more than 253 million people.^[3]The World Health Organization (WHO) released the "World Report on Vision" in 2019.^[4]It shows that China is one of the countries with the largest number of blind and visually impaired people in the world. As the leading irreversible blinding eye disease, there are more than 40 million patients with fundus diseases in China, with over 3 million new cases added each year. Among them, 50% of the patients are aged between 40-60.

DME, as one of the important conditions of fundus diseases, is seeing a yearly increase in the number of patients in China. According to the 2021 statistics from the International Diabetes Federation (IDF), the number of diabetes patients in China exceeds 140 million, ranking first in the world.^[5]Studies show that approximately one in three diabetic patients has diabetic retinopathy (DR).^[6]DME is a disease characterized by central retinal thickening in the macula due to capillary leakage, posing a significant threat to vision. DME can occur at any stage of DR and requires long-term, regular follow-up and treatment, making it a key focus in clinical practice.

Professor Sun Xiaodong from the First People's Hospital of Shanghai said:"As a major microvascular complication of diabetes, blindness and low vision caused by diabetic retinopathy have become significant public health issues. After the loading phase of intravitreal injections of single-target anti-vascular endothelial growth factor (VEGF) drugs, over 80% of patients still experience retinal fluid accumulation, and the high-frequency monthly injections also result in more than 60% of patients failing to achieve 'DRY MACULAR' treatment during the maintenance phase. These factors lead to the majority of patients with fundus diseases not achieving ideal treatment outcomes. The outstanding global and Chinese clinical data of Faricimab has greatly excited clinicians: 75% of patients achieved no fluid accumulation after the loading phase treatment, and 80% of patients could extend their treatment intervals to 3-4 months. Patients can achieve significant therapeutic benefits with fewer injections. The approval of this innovative dual-pathway drug is believed to become an important milestone in the development of fundus disease treatment in China."

Faricimab's approval this time is mainly based on the positive results of the two global Phase III clinical studies, YOSEMITE and RHINE.^[7]Studies show that approximately 80% of patients with diabetic macular edema can extend the treatment interval of faricimab to 3-4 months, allowing patients to achieve the same or even better treatment outcomes with fewer treatments.^[8]Moreover, the 1-year study results of the Chinese subgroup of patients with DME treated with Faricimab showed that: In the personalized treatment group with Faricimab, 75% of patients could achieve a dosing interval of 12 weeks or more, and 50% of patients could reach 16 weeks. The overall safety and tolerability data were consistent with the global data.

As the first innovative bispecific antibody specifically designed for intravitreal injection, Faricimab can simultaneously target and inhibit key pathogenic factors causing various retinal diseases: Angiopoietin-2 (Ang-2) and Vascular Endothelial Growth Factor A (VEGF-A). Building on the foundation of existing anti-VEGF treatments, it makes a bold breakthrough by strongly and specifically binding to and inhibiting both Ang-2 and VEGF-A pathways. This enhances vascular stability while also reducing retinal leakage.

Dr. Li Xin, Head of Roche Global Pharma Development Center in China, stated:"Very pleased to see that faricimab has been officially approved in China. With its innovative mechanism of action, faricimab can better help patients with fundus diseases in China achieve long-term vision benefits and quality of life improvement. Roche has a rich pipeline of retinal disease products in the ophthalmology field, with nearly 20 new molecular entities or indications under development at various stages of clinical trials progressing in an orderly manner. In the future, we will continue to work with internal and external partners to bring more innovative drugs to China for the benefit of more Chinese patients."

Roche Pharmaceuticals China President Bian Xin stated:"As an innovation-driven company, Roche has continuously invested in and conducted research and development in the field of ophthalmology, having developed the world's first anti-VEGF drug more than a decade ago. Today, we are thrilled to announce that the latest achievement in Roche’s pioneering therapy — Faricimab — has been officially approved in China. As the world’s first dual-pathway retinal disease treatment, Faricimab will provide an enhanced therapeutic experience, benefiting tens of millions of patients with retinal diseases in China. Moving forward, Roche will continue to uphold the principle of 'acting on patients' needs first,' bringing more innovative treatments for retinal diseases to Chinese patients. We will also collaborate with all partners to support the successful implementation of China’s 14th Five-Year Plan for National Eye Health."

Currently, Faricimab has been approved for marketing in more than 80 countries and regions worldwide, including the United States, the United Kingdom, Japan, and the European Union, with over 2 million injections administered within two years.^[7]In China, leveraging the "pilot first" special policy advantage, faricimab was introduced to Boao Lecheng, Hainan on October 21 and completed the first treatment in the country. In addition to the recently approved diabetic macular edema (DME), Roche has also submitted marketing applications for faricimab for other indications, including neovascular (wet) age-related macular degeneration (nAMD), macular edema secondary to branch retinal vein occlusion (BRVO), and macular edema secondary to central retinal vein occlusion (CRVO), which are currently undergoing technical review by the pharmaceutical regulatory authorities.