On January 3, 2024, Roche announced that the China National Medical Products Administration (NMPA) has officially approved the ophthalmic bispecific antibody injection, Vabysmo.®（Vabysmo®, Generic Name: Faricimab) for the treatment of neovascular age-related macular degeneration (nAMD). Roche®Is the world's first innovative dual-pathway retinal treatment drug. Its dual mechanism of action, which simultaneously targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A), along with its sustained efficacy, can inhibit neovascularization while enhancing vascular stability, improving patients' long-term visual outcomes and quality of life. This follows the recent approval for diabetic macular edema (DME), Roche...®The second indication approved in China is expected to provide a new treatment option for Chinese patients with nAMD.
Age-related Macular Degeneration (AMD) is one of the leading causes of severe and irreversible vision loss worldwide. In China, a study analyzing vision impairment and blindness from 1990 to 2019 revealed that AMD caused moderate to severe vision impairment in 2.28 million individuals and blindness in 320,000 people. With the progression of an aging society in China, the number of AMD patients is projected to increase to 55.19 million by 2050, further exacerbating the socioeconomic burden caused by AMD.
Neovascular Age-Related Macular Degeneration (nAMD), also known as exudative or wet AMD, occurs when choroidal neovascularization (CNV) abnormally grows into the macular area of the retina, leading to leakage and bleeding. This interferes with retinal function and ultimately causes rapid vision loss or even blindness. Statistics show that approximately 20 million people worldwide are affected by nAMD, which is one of the leading causes of vision loss in individuals over 60 years old.
Roche®Principal Investigator of the Phase III Clinical Study in China for nAMD, Professor Chen Youxin from Peking Union Medical College Hospital, stated: "In the pathogenesis of nAMD, the key factors leading to choroidal neovascularization are not only the abnormal increase of VEGF-A acting on vascular endothelial cells, which generates new blood vessels, but also the elevated levels of Ang-2 (Angiopoietin-2) acting on pericytes, causing vascular leakage. In the era of traditional single-pathway therapies, the improvement of retinal fluid in nAMD patients with only VEGF inhibition has been less than ideal. More than half of nAMD patients still have retinal fluid after treatment with traditional single-pathway drugs. Additionally, current anti-VEGF therapies require long-term and frequent intravitreal injections, affecting patient compliance and increasing their financial burden. There is an urgent clinical need to further explore drugs that innovate in mechanism, effectively eliminate retinal fluid, and help patients achieve long-lasting benefits."
Roche®The approval was mainly based on the positive results of two global Phase III clinical trials, TENAYA and LUCERNE. Compared with the current situation where more than half of the patients still have retinal fluid after receiving single-pathway drug injections, studies have shown that Roche's drug®Heavy-hitting during the loading period, achieving approximately 80% of nAMD patients receiving Roche's Lucentis.®The effusion was eliminated after treatment. Approximately 60% of nAMD patients received Roche.®The treatment dosing interval can reach up to 16 weeks, with approximately 80% of patients achieving 12 weeks or more. The long maintenance period without recurrence allows patients to achieve stable disease control with fewer treatments. Additionally, Roche's product, Lucentis,®One-year study results of the Chinese subpopulation for the treatment of nAMD patients show: Lucentis®In the personalized treatment group, 87.3% of patients could achieve a dosing interval of 12 weeks or more, and 67.3% of patients reached 16 weeks, with proportions higher than those in the global study. The overall safety and tolerability data were consistent with the global data.
As the first innovative bispecific antibody specifically designed for intravitreal injection, Roche's product®It can simultaneously target and inhibit the key pathogenic factors Ang-2 and VEGF-A, which cause various retinal diseases, making a bold breakthrough based on the original anti-VEGF treatment. It strongly and specifically binds to and inhibits both pathways at the same time, enhancing vascular stability while reducing fundus leakage.
Dr. Li Xin, Head of Roche Global Pharma Development China Center, stated: "We are very pleased to see another significant indication of Faricimab successfully approved in China. From ushering in the anti-VEGF era for retinal treatment in 2006 to launching Faricimab, the world’s first bispecific antibody drug for ophthalmology today, Roche has always been committed to enhancing long-term vision benefits and improving the quality of life for patients with retinal diseases. We will also continue our efforts to advance the development of new molecular entities or indications in ophthalmology, striving to bring more innovative medicines to patients in China."
Ms. Bian Xin, President of Roche Pharmaceuticals China, stated: "Retinal diseases are becoming the leading cause of blindness among the elderly in China. The '14th Five-Year Plan' for National Eye Health in China has also added retinal diseases as a key focus for prevention and treatment. The consecutive approvals of faricimab for the treatment of DME and nAMD, two major types of retinal diseases, reflect the Chinese government's high level of attention to retinal conditions. Roche will continue to uphold the principle of 'acting on the needs of patients first' and work hand-in-hand with all partners to expand the accessibility of faricimab, create comprehensive diagnostic and treatment solutions for retinal diseases, and reduce the burden and blindness rate caused by retinal diseases in China."
China is Roche®The 90th country approved, within the past two years, Roche®Globally, it has already helped more than 2.5 million patients. Roche has been deeply involved in the ophthalmology field for many years. Over 20 years ago, it successfully developed and launched the world's first, as well as China's first, intravitreal injection anti-VEGF drug. After 20 years of relentless exploration and effort, Roche once again successfully developed Luoshi Jia.®, has finally stepped into the spotlight in the Chinese market.
As the first and currently only bispecific antibody in the ophthalmology field, Roche's Vabysmo®The DME indication was approved in China in December 2023, and the RVO indication is currently under review. Roche Ophthalmology boasts a robust product pipeline; in addition to the approved and under-review indications, more than ten molecular entities are expected to enter clinical trials. Through continuous technological innovation, Roche aims to collaborate with experts to advance the prevention and treatment of retinal diseases in China.
