The phase 2 clinical trial data evaluating the efficacy, safety, and dosing intervals of high-dose IBI302 were presented during the annual 2025 ARVO meeting.
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Innovent Biologics recently announced its latest 1-year results from its phase 2 clinical trial of efdamrofusp alfa, a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein.1
The phase 2 clinical trial evaluated the efficacy, safety, and dosing intervals of high-dose IBI302 (NCT05403749) in Chinese subjects with neovascular age-related macular degeneration ( nAMD) over a one-year treatment period.
Professor Xiaodong Sun, who is with Shanghai General Hospital affiliated to Shanghai Jiao Tong University School of Medicine, presented the results at the 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) held May 4-8 in Salt Lake City.
“It is my privilege to present the latest research findings on IBI302 to the global ophthalmic community at the ARVO meeting as the principal investigator,” Sun said in a release. “While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of intravitreal injections and follow-up visits can significantly impact patient compliance.”
A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or aflibercept 2.0 mg group. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from the baseline to week 40. The study lasted 52 weeks.
“Current drug development focuses on multi-target strategies and extended dosing intervals to reduce the treatment burden by decreasing injection frequency,” Sun said.
“Notably, IBI302 – a novel global first-in-class bispecific molecule (anti-VEGF/anti-complement) – recently reported phase 2 data showing that its high-dose cohorts met the primary endpoint. The treatment group achieved approximately 10-letters improvement in visual acuity from baseline at 1 year, with over 80% of subjects demonstrating potential for at least 12-weeks extended dosing intervals. Additionally, preliminary observations in IBI302 group suggest potential efficacy in inhibition of macular atrophy.”
Results from the phase 2 clinical study of IBI302 showed 6.4 mg/8.0 mg IBI302 competitive efficacy and safety profiles:
“We anticipate this innovative therapy will successfully complete the phase 3 registration trial, providing nAMD patients with more effective, patient-friendly options,” Sun said.
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