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].

Core Viewpoint - Innovent Biologics presented promising results from its Phase 2 clinical trial of efdamrofusp alfa (IBI302) for treating neovascular age-related macular degeneration (nAMD), highlighting its efficacy, safety, and potential for extended dosing intervals [1][2][3]. Group 1: Clinical Trial Results - The Phase 2 study involved 132 subjects randomized into three groups: IBI302 6.4 mg, IBI302 8.0 mg, and Aflibercept 2.0 mg, with the primary endpoint being the change in best corrected visual acuity (BCVA) from baseline to week 40 [2][4]. - IBI302 demonstrated competitive efficacy with BCVA gains of +10.5, +11.0, and +9.8 ETDRS letters for the 6.4 mg, 8.0 mg, and Aflibercept groups respectively at week 40, sustained through week 52 [4]. - Over 80% of participants in the IBI302 groups maintained visual benefits with a 12-week dosing interval, indicating potential for reduced treatment burden [4][5]. Group 2: Safety and Efficacy - No new safety signals were identified during the trial, and the incidence of adverse events in IBI302 groups was similar to Aflibercept, with no cases of retinal vasculitis reported [4][5]. - IBI302 showed potential efficacy in inhibiting macular atrophy, with a nearly 40% reduction in incidence compared to Aflibercept (4.9% in IBI302 vs. 8.3% in Aflibercept) [4]. Group 3: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and eye diseases, and has launched 15 products to date [7]. - The company is actively collaborating with over 30 global healthcare partners and has multiple assets in various stages of clinical trials [7].