Surrozen’s new eye drug clears FDA hurdle, amps up prospects for diabetic macular edema treatment

Surrozen has received FDA approval to test SZN-8141, a promising bifunctional antibody aimed at tackling diabetic macular edema. Early results are expected in 2027, marking a significant step in retinal disease treatment development.

The U.S. Food and Drug Administration has cleared Surrozen’s investigational new drug application for SZN-8141, opening the way for the biotechnology company to begin human testing of the eye treatment for diabetic macular edema, a leading cause of vision loss in people with diabetes. According to Surrozen, the drug is designed as a bifunctional antibody that combines Wnt pathway activation with VEGF suppression, two approaches aimed at limiting retinal damage and fluid leakage.

The company said the first patient is expected to be dosed in the fourth quarter in the DUET phase 1b/2a study. In the initial stage, researchers will assess safety, tolerability, drug behaviour in the body, immune response and early signs of retinal function and structure after a single intravitreal injection. The second stage will compare two dose levels of SZN-8141 with faricimab, sold by Genentech as Vabysmo, in about 60 treatment-naive patients.

Surrozen has said it expects early results from the trial in 2027, with one report placing the readout in the second half of that year. The company also plans to pursue SZN-8141 in neovascular age-related macular degeneration and other retinal vascular diseases, underscoring its broader ambition to build a pipeline in ophthalmology around Wnt-based biology.

The regulatory clearance also unlocks financing tied to Surrozen’s March 2025 private placement. The company said the milestone satisfies the condition for a second closing that is expected to bring in about $95.1 million in gross proceeds, with completion projected for around Oct. 20, 2026. Surrozen said the funds will support development of SZN-8141 and SZN-8143, along with general corporate purposes.