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The First Prescription of the Innovative Ocular Drug Faricimab Issued

ZhangYiLin Thu, Mar 28 2024 11:20 AM EST

The dual-pathway era for treating retinal diseases in China has officially arrived. On March 13, 2024, major public medical institutions, including Beijing Hospital, Shanghai First People's Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University, and the Second Affiliated Hospital of Zhejiang University School of Medicine, issued the first batch of prescriptions for Faricimab (trade name: Lucentis) in China. This marks a significant milestone as, after decades, patients with retinal diseases are finally receiving a new treatment option, potentially addressing clinical challenges that traditional medications could not solve. Faricimab is the world's first intraocular injection of a bispecific antibody, targeting both angiopoietin-2 (ang-2) and vascular endothelial growth factor A (VEGF-A). Its dual-action mechanism and long-lasting benefits protect both the inner and outer layers of retinal blood vessels, inhibiting neovascularization while enhancing vascular stability. This improves long-term visual outcomes and enhances the quality of life for patients. Approved in China by the end of 2023 for the treatment of diabetic macular edema and neovascular (wet) age-related macular degeneration, Faricimab has emerged as a potent and safe new treatment option in the field of retinal disease. In the realm of diabetic macular edema, two global Phase III clinical studies (YOSEMITE/RHINE) have shown that after a loading phase of treatment, 75% of patients experienced no fluid accumulation, and about 80% could extend their Faricimab treatment intervals to 3-4 months. Results from the Chinese subgroup one-year study indicated that 75% of patients in the Faricimab individualized treatment group reached a dosing interval of 12 weeks or more, and 50% reached 16 weeks, with a superior visual acuity improvement compared to the control group. The overall safety and tolerance data were consistent with global findings. In the area of neovascular age-related macular degeneration, two global Phase III clinical trials (TENAYA and LUCERNE) revealed that about 80% of patients eliminated fluid accumulation completely after the loading phase. Approximately 60% could extend their dosing interval to 16 weeks, with around 80% reaching 12 weeks or more. The Chinese subgroup one-year study showed that 87.3% of patients in the Faricimab individualized treatment group could extend their dosing interval to 12 weeks or more, and 67.3% reached 16 weeks, a proportion higher than the global studies, with overall safety and tolerance data consistent with global findings. Retinal diseases, as the leading cause of irreversible blindness, affect over 40 million patients in China. Diabetic macular edema and neovascular age-related macular degeneration are the primary types of retinal diseases. The "14th Five-Year National Eye Health Plan (2021-2025)" has officially added retinal diseases as a significant disease for prevention and treatment, focusing on key populations such as the elderly, aiming to reduce disease burden and blindness rates. Professor Dai Hong, the chief ophthalmologist at Beijing Hospital, stated that in the hospital's clinical application, about 80% of patients with diabetic macular edema and neovascular age-related macular degeneration who received Faricimab dual-pathway treatment could extend their treatment interval to 3-4 months without recurrence during the maintenance phase, allowing patients to achieve similar or even better treatment outcomes with fewer treatments. Professor Sun Xiaodong, Deputy Director of Shanghai First People's Hospital and the principal investigator of the Phase III study of Faricimab for diabetic macular edema in China, mentioned that after the loading phase of intraocular injection of anti-vascular endothelial growth factor single-target drugs, over 80% of patients still had retinal fluid accumulation, and the high-frequency monthly injections resulted in more than 60% of patients not achieving "DRY MACULAR" during the maintenance phase, leading to less than ideal treatment outcomes for most patients with retinal diseases. Professor Jin Chenjin, the chief physician at Zhongshan Ophthalmic Center of Sun Yat-sen University, highlighted that Faricimab is an advanced dual-pathway medication for treating vascular diseases of the retina, capable of reducing vascular permeability, inhibiting pathological neovascularization, and restoring vascular stability. The approval of Faricimab in China is a testament to the advancement of ophthalmology at the international level in the country. (Original Title: Over 40 Million Patients with Retinal Diseases in China, the First Prescription of the Innovative Ocular Drug Faricimab Issued)