Innovent Reports 1-Year IBI302 Data in nAMD at ARVO 2025

Innovent Biologics has announced the latest 1-year results from its Phase 2 clinical trial evaluating IBI302 (efdamrofusp alfa), a novel VEGFR-antibody complement receptor 1 (CR1) fusion protein, in Chinese patients with neovascular age-related macular degeneration (nAMD). The findings were presented by Professor Xiaodong Sun of Shanghai General Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, at the ARVO 2025 Annual Meeting, held May 4–8 in Salt Lake City, Utah.

“While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of injections and follow-up visits impacts patient compliance. IBI302’s dual-target approach may reduce this burden,” said Prof. Sun during the presentation.

Study Design: Randomized Comparison of High-Dose IBI302 to Aflibercept

The Phase 2 trial (NCT05403749) enrolled 132 subjects, randomized 1:1:1 to receive:

• IBI302 6.4 mg

• IBI302 8.0 mg

• Aflibercept 2.0 mg (control)

The primary endpoint was the change in best-corrected visual acuity (BCVA) at week 40, with overall treatment extending through 52 weeks.

Primary Endpoint Met; Strong Visual and Anatomical Gains Observed

According to the data presented:

• Both IBI302 dose groups met the primary endpoint, with approximately 10-letter BCVA improvement sustained through week 52.

• Over 80% of participants in the IBI302 arms maintained visual benefits on 12-week dosing intervals, suggesting potential for reduced treatment burden.

• Central subfield thickness (CST) reductions at week 52 were greater in IBI302 groups compared to aflibercept:

• IBI302 6.4 mg: –154.58 µm

• IBI302 8.0 mg: –174.69 µm

• Aflibercept 2.0 mg: –131.18 µm

Macular Atrophy Findings and Pooled Phase 2 Analysis

Pooled data from two Phase 2 trials (CIBI302A201 and CIBI302A202) indicated that IBI302 may reduce the incidence of macular atrophy (MA):

• At week 52, MA incidence was 4.9% in the IBI302 group versus 8.3% in the aflibercept group, suggesting a nearly 40% relative reduction.

Safety Profile Comparable to Aflibercept

• No retinal vasculitis or new safety signals were observed.

• The incidence of adverse events was comparable between IBI302 and aflibercept groups.

• Reported adverse events were in line with expectations and no dose-limiting toxicities were noted.

Expert Commentary: A Promising Candidate for Phase 3 Advancement

“IBI302 is a first-in-class bispecific anti-VEGF/anti-complement therapy showing compelling clinical potential. These findings support its continued development and raise the possibility of a more patient-friendly treatment approach for nAMD,” said Prof. Sun.
“We anticipate this innovative therapy will successfully complete its Phase 3 registration trial and broaden options for patients with neovascular AMD.”