Innovent Biologics Presents Positive IBI302 Results for nAMD at ARVO 2025

Innovent Biologics Presents Positive IBI302 Results for nAMD at ARVO 2025

China-based Innovent Biologics, Inc. (HKG: 1801) announced the presentation of 1-year results from its Phase II trial evaluating IBI302 (efdamrofusp alfa) in neovascular age-related macular degeneration (nAMD) at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The trial assessed the drug’s efficacy and safety in treating this common cause of vision loss.

IBI302 Mechanism and Trial Design
IBI302 is a bispecific fusion protein combining a recombinant human vascular endothelial growth factor receptor (VEGFR) antibody with human complement receptor 1 (CR1). In the trial, 132 subjects were randomized 1:1:1 to receive either IBI302 6.4 mg, IBI302 8.0 mg, or aflibercept 2.0 mg. The primary endpoint assessed the change in best corrected visual acuity (BCVA) from baseline to week 40, with the study duration being 52 weeks.

Trial Results and Benefits
Results demonstrated clear overall benefits in the IBI302 groups, with the study meeting its primary endpoint. IBI302 showed visual improvement effects comparable to aflibercept, with over 80% of participants in the IBI302 arms maintaining visual benefits on a 12-week dosing regimen. Anatomical outcomes favored IBI302, showing significantly greater reductions in central subfield thickness (CST) versus the aflibercept group, along with a 40% lower incidence of newly diagnosed macular atrophy. Safety profiles were comparable, with IBI302 exhibiting no reported cases of retinal vasculitis and no new safety signals identified.-Fineline Info & Tech