SZN-8141

October 2, 2026: Surrozen (NASDAQ: SRZN) said the FDA allowed its IND for SZN-8141 to become effective, clearing the bifunctional Wnt agonist/VEGF antagonist for clinical development as an intravitreal treatment for diabetic macular edema (DME). The company expects to dose the first patient in DUET, a Phase 1b/2a study in DME, in Q4 2026, with initial data expected in 2H 2027.

DUET includes an open-label single-ascending-dose Phase 1b in treatment-naïve and previously treated DME patients, followed by a randomized, double-masked Phase 2a dose-expansion comparing two dose levels of SZN-8141 versus Vabysmo in about 60 treatment-naïve DME patients. Endpoints include safety, tolerability, PK, immunogenicity, and exploratory retinal function/anatomy measures including BCVA, OCT, OCT-A, and fluorescein angiography; Part 2 will also assess durability after three monthly doses plus four months of follow-up.

The IND clearance also triggers the second closing of Surrozen’s March 2025 private placement, expected to bring about $95.1 million in gross proceeds around October 20, 2026, to support development of SZN-8141, SZN-8143, and operations. The release also notes planned development of SZN-8141 in wet AMD and describes SZN-8143 as a preclinical retinal program for DME, wet AMD, and uveitic macular edema.