Efdamrofusp Alfa (IBI-302): A Comprehensive Monograph on a First-in-Class Bispecific Therapy for Retinal Disease

I. Executive Summary

Efdamrofusp alfa, also known by its development code IBI-302, represents a significant evolution in the therapeutic landscape for neovascular retinal diseases. Developed by Innovent Biologics, it is an intravitreally administered, first-in-class bispecific fusion protein engineered to simultaneously address two fundamental pathogenic pathways in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).[1] The core value proposition of Efdamrofusp alfa is built upon a triad of strategic advantages that collectively address the most pressing unmet needs in contemporary retinal care.

First, its novel dual mechanism of action involves the concurrent inhibition of vascular endothelial growth factor (VEGF) and the complement system. By neutralizing both VEGF isoforms and the central complement components C3b and C4b, Efdamrofusp alfa targets both the neovascularization and the chronic inflammation that drive disease progression and vision loss.[3] This integrated approach moves beyond the purely anti-angiogenic focus of legacy therapies.

Second, the clinical development program has provided robust evidence for extended dosing durability. Data from comprehensive Phase 2 trials demonstrate the potential for treatment intervals of 12 weeks or longer (Q12W+) in a majority of patients with nAMD, a feature that directly confronts the high treatment burden associated with the frequent injections required by many current standards of care.[1] This durability is a cornerstone of its clinical and commercial strategy.