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Core Viewpoint - Innovent Biologics has initiated the Phase 2 clinical study of efdamrofusp alfa for treating diabetic macular edema (DME), a significant health issue affecting millions of diabetic patients in China [1][2][3]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology, cardiovascular, metabolic, autoimmune, and ophthalmology [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline for future growth [10]. Clinical Study Details - The Phase 2 study (NCT06908876) will enroll 150 participants, randomized into three groups to evaluate the efficacy and safety of efdamrofusp alfa compared to Faricimab [2]. - The primary endpoint of the study is the change in best corrected visual acuity (BCVA) at week 16 [2]. Disease Context - DME is a leading cause of vision impairment among the diabetic population in China, with an estimated 4 to 5 million patients affected [3]. - The condition is primarily driven by microvascular damage and inflammation, leading to retinal edema and visual impairment [4][8]. Treatment Landscape - Current treatments for DME include anti-VEGF agents and glucocorticoids, but they require frequent injections, which can lead to poor patient compliance [4]. - Efdamrofusp alfa is a first-in-class bispecific fusion protein that targets both VEGF and complement pathways, potentially offering improved efficacy and extended dosing intervals [5][9]. Expert Insights - The Principal Investigator of the study highlighted the significant unmet medical needs in DME treatment, emphasizing the potential of efdamrofusp alfa to address these challenges [6]. - The Senior Vice President of Clinical Development noted that this study is the first to compare two dual-target agents in DME, which could pave the way for future Phase 3 trials [6].