The FDA has cleared Surrozen’s investigational new drug application for SZN-8141, allowing the company to begin clinical testing of the investigational therapy in patients with diabetic macular edema (DME).

SZN-8141 is an intravitreal bifunctional antibody that combines Frizzled 4 (FZD4)-mediated Wnt pathway agonism with VEGF antagonism. Surrozen expects to dose the first patient in the phase 1b/2a DUET study during the fourth quarter of 2026.

The open-label phase 1b portion will evaluate ascending single doses of SZN-8141 in treatment-naïve and previously treated patients with DME. Assessments will include safety and tolerability, pharmacokinetics, immunogenicity, visual acuity, and retinal imaging.

The randomized, double-masked phase 2a portion is expected to compare 2 dose levels of SZN-8141 with faricimab-svoa (Vabysmo; Genentech) in approximately 60 treatment-naïve patients. Participants are planned to receive 3 monthly injections followed by 4 months of follow-up to assess durability.

Surrozen expects initial DUET data in the second half of 2027. The company is also planning development of SZN-8141 for neovascular age-related macular degeneration and is evaluating its use in other retinal vascular diseases. RP