Innovent reports Phase 3 STAR study results showing efdamrofusp alfa (IBI302) met its primary endpoint and enabled extended dosing intervals in patients with neovascular age-related macular degeneration.
Written By: Marka Sheshi, PharmD
Reviewed By: Pharmacally Editorial Team
Innovent Biologics has announced that the Phase 3 registration STAR study (NCT05972473) evaluating efdamrofusp alfa (IBI302) met its primary endpoint in patients with neovascular age-related macular degeneration (nAMD). The investigational therapy demonstrated non-inferior improvements in vision compared with aflibercept, while enabling extended dosing intervals for a large proportion of patients.
At week 52, patients treated with efdamrofusp alfa achieved a mean improvement of 10.37 ETDRS letters in best-corrected visual acuity (BCVA) compared with 10.11 letters with aflibercept, meeting the study’s primary endpoint of non-inferiority. In addition to visual gains, the therapy showed strong durability outcomes, with 86% of patients achieving dosing intervals of 12 weeks or longer, and 72.8% reaching dosing intervals of up to 16 weeks during the maintenance phase.
The study also evaluated retinal safety outcomes. The incidence of macular atrophy was 1.5% in the IBI302 group compared with 2.9% in the aflibercept arm, suggesting a potential reduction in the risk of this vision-threatening complication. Overall, efdamrofusp alfa demonstrated a safety profile comparable to aflibercept, with most ocular adverse events reported as mild to moderate.
Efdamrofusp alfa is a first-in-class bispecific fusion protein designed to simultaneously inhibit vascular endothelial growth factor (VEGF) and the complement pathway, two key biological drivers involved in retinal neovascularization and inflammation. By targeting both mechanisms, the therapy aims to improve visual outcomes while reducing treatment burden associated with frequent intravitreal injections.
The STAR study is a randomized, double-masked, active-controlled Phase 3 trial comparing IBI302 with aflibercept in patients with neovascular age-related macular degeneration. The trial evaluated changes in best-corrected visual acuity over 52 weeks along with durability and safety outcomes to support potential regulatory submissions.
Professor Xiaodong Sun said the Phase 3 STAR results show that IBI302 achieved vision gains comparable to aflibercept while enabling extended dosing intervals of up to 16 weeks in many patients, potentially reducing treatment burden and lowering the risk of macular atrophy.
Dr. Lei Qian said the positive STAR study results support plans to file a New Drug Application for efdamrofusp alfa and advance Innovent’s ophthalmology pipeline to deliver more durable and patient-friendly treatments for retinal diseases.
Neovascular age-related macular degeneration is a leading cause of vision loss worldwide and is characterized by abnormal blood vessel growth beneath the retina. Although anti-VEGF therapies have significantly improved outcomes, many patients still require frequent injections, highlighting the need for longer-acting treatment options that can maintain efficacy while reducing treatment burden.
Reference
The Phase 3 Registration STAR Study of Efdamrofusp Alfa (IBI302) Met its Primary Endpoint, Making it the First Self-developed Extended-interval Treatment for nAMD in China, 24 March 2026, Press Release
A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD, ClinicalTrials.gov ID NCT05972473, https://clinicaltrials.gov/study/NCT05972473
About the Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.