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A new dual-action eye drug just got the green light. The FDA has cleared an investigational new drug (IND) application for SZN-8141, a Wnt agonist and VEGF antagonist antibody targeting diabetic macular edema (DME). Developed by Surrozen, the drug will now enter the phase 1b/2a DUET clinical study, with the first patient expected to be dosed before year-end and initial data anticipated in 2027.
A new dual-action eye drug just got the green light. The FDA has cleared an investigational new drug (IND) application for SZN-8141, a novel Wnt agonist and VEGF antagonist antibody developed by Surrozen for the treatment of diabetic macular edema (DME). This clearance paves the way for the phase 1b/2a DUET clinical study, with the first patient expected to be dosed in Q4 2026.
The trial is structured in two parts. Phase 1b will assess safety, tolerability, pharmacokinetics, and immunogenicity following a single intravitreal injection in both treatment-naive and previously treated patients over 3 months. Phase 2a will then compare two dose levels of SZN-8141 against the already-approved Vabysmo (faricimab-svoa) in approximately 60 treatment-naive patients. Surrozen also plans to explore SZN-8141 for neovascular age-related macular degeneration and other retinal vascular diseases.
By the Numbers:
Why it matters: DME is a leading cause of vision loss in people with diabetes, and current anti-VEGF therapies don't work for everyone. SZN-8141's dual mechanism — targeting both the Wnt pathway and VEGF — could offer a new treatment option for patients who don't respond adequately to existing therapies, making this an important milestone in retinal disease research.