SOUTH SAN FRANCISCO, Calif. — October 2, 2026

Surrozen, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SZN-8141, enabling the company to advance its investigational ophthalmic therapy into clinical development for diabetic macular edema (DME). SZN-8141 is a bifunctional antibody designed to combine Frizzled 4 (FZD4)-mediated Wnt agonism with vascular endothelial growth factor (VEGF) antagonism and is being developed as an intravitreal injection. Surrozen expects to dose the first patient in the Phase 1b/2a DUET study during the fourth quarter of 2026. The FDA milestone also satisfies a condition for the second closing of Surrozen’s March 2025 private placement, which is expected to provide approximately $95.1 million in gross proceeds before fees and expenses. The funding is intended to support development of SZN-8141, SZN-8143 and the company’s broader operating activities.

SZN-8141 Combines Wnt and VEGF Targeting

SZN-8141 is designed to address two biological pathways involved in retinal vascular disease through a single molecule. Surrozen is developing the candidate for DME and neovascular age-related macular degeneration (wet AMD), with the goal of combining FZD4-mediated Wnt pathway activation with VEGF inhibition. Current treatment for DME, diabetic retinopathy, retinal vein occlusion and wet AMD commonly relies on intravitreal anti-VEGF therapies, including monotherapies and dual-pathway approaches targeting VEGF and Ang-2. According to Surrozen, preclinical retinopathy models showed that SZN-8141 stimulated Wnt signaling, promoted normal retinal vessel regrowth and suppressed pathological vessel growth. The company believes the combination mechanism could potentially provide advantages over therapies that act through a single pathway. Surrozen also pointed to clinical evidence supporting Wnt pathway activation in retinal vascular disease, including results from Merck’s FZD4-mediated Wnt agonist MK-3000 in DME..

DUET Study to Evaluate Safety and Early Activity

The Phase 1b/2a DUET study will evaluate the safety, tolerability, pharmacokinetics and early biological and clinical activity of SZN-8141 in patients with DME. The first part will be an open-label, single-ascending-dose Phase 1b study enrolling both treatment-naïve and previously treated patients. Participants will receive a single intravitreal injection and undergo approximately three months of follow-up, with assessments including best-corrected visual acuity (BCVA), optical coherence tomography (OCT), OCT angiography (OCT-A) and ultra-widefield fluorescein angiography. The randomized, double-masked Phase 2a dose-expansion portion is expected to evaluate two SZN-8141 dose levels against Vabysmo (faricimab-svoa) in approximately 60 treatment-naïve DME patients. Participants are planned to receive three monthly doses followed by four months of follow-up to assess durability. Initial clinical data are expected in the second half of 2027.

Advertisement

cGxPJobs Banner

Surrozen Advances Wnt-Based Ophthalmology Pipeline

The SZN-8141 IND clearance strengthens Surrozen’s broader strategy of developing multifunctional Wnt-based therapies for sight-threatening retinal diseases. The company is also developing SZN-8143, another investigational candidate combining FZD4 agonism and VEGF antagonism, with additional IL-6 antagonism, for DME, wet AMD and uveitic macular edema. The company believes its antibody-engineering platform can selectively activate Wnt signaling while simultaneously addressing other disease pathways involved in retinal vascular disorders. The approximately $95.1 million expected from the second closing of the March 2025 private placement is intended to provide additional resources for advancing SZN-8141 and SZN-8143. With SZN-8141 now cleared for clinical development, Surrozen is moving its Wnt-based ophthalmology strategy from preclinical development toward human testing, with the upcoming DUET study expected to provide the first clinical assessment of the candidate’s safety and potential biological activity in DME.

Source: Surrozen, press release