IBI302 (Efdamrofusp alfa), a globally licensed asset developed by Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) in its portfolio, has met the primary endpoint at 52 weeks in the STAR pivotal Phase III study in patients with neovascular age-related macular degeneration (nAMD). The results demonstrate non-inferior vision improvement versus current standard of care (aflibercept, Eylea), alongside a differentiated extended dosing interval and a meaningful reduction in macular atrophy incidence.
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70%+
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10.37
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−50%
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Patients maintaining efficacy with once-every-four-months injection
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ETDRS letters of vision improvement (52 weeks)
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Reduction in new-onset macular atrophy vs. control (1.5% vs 2.9%)
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The STAR study (NCT05972473) is a Phase III randomised controlled trial evaluating 8 mg IBI302 versus 2 mg aflibercept (standard of care, Eylea) in 600 patients with nAMD in China, enrolled 1:1 across the two treatment arms.
Key Results Highlights
- Primary endpoint met: Mean best-corrected visual acuity (BCVA) improvement of +10.37 ETDRS letters at weeks 44, 48, and 52 — statistically non-inferior to standard of care.
- Extended dosing interval: More than 70% of patients were able to maintain their vision improvement with just one injection every four months after completing initial treatment — a significant reduction in hospital visits compared to existing therapies, which typically require injections every two months.
- Macular atrophy suppression: New-onset macular atrophy occurred in 1.5% of patients receiving IBI302 versus 2.9% in the control group — a reduction of approximately 50%. This is the most differentiated macular atrophy signal seen in the field to date, consistent with the drug's complement-inhibiting mechanism.
- Favourable safety profile: The overall rate of adverse events in the IBI302 group was comparable to the standard-of-care control group. Ocular adverse events were predominantly mild to moderate in severity.
The positive STAR results validate the core value of IBI302 as a next-generation treatment for macular degeneration: fewer injections into the eye meaningfully improves the treatment experience and patient adherence, while the ability to suppress macular atrophy represents a differentiated advantage that no currently available therapy can offer.
Innovent Biologics is actively preparing to submit a New Drug Application (NDA) for IBI302 in China. AP Biosciences will continue to monitor the development progress and regulatory pathway for IBI302, with a commitment to advancing treatment options for patients with wet macular degeneration.
