Surrozen Announces Submission of IND Application for SZN-8141 for the Treatment of Diabetic Macular Edema

SOUTH SAN FRANCISCO, Calif., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Surrozen or the Company) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics to harness the power of Wnt signaling to address the underlying drivers of disease in sight-threatening ophthalmic conditions, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration seeking to evaluate SZN-8141, a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody, for the treatment of diabetic macular edema (DME).

“We believe SZN-8141 has the potential to offer a differentiated approach to retinal vascular disease by combining two complementary mechanisms, activation of the Wnt pathway and inhibition of VEGF, in a single molecule,” said Craig Parker, Chief Executive Officer of Surrozen. “By bringing together these mechanisms, SZN-8141 is designed to both address vascular leakage and promote retinal vascular integrity. We are excited to advance SZN-8141 into clinical development and evaluate this approach in patients with diabetic macular edema in the DUET Phase 1b/2a study.”

In preclinical studies, SZN-8141 demonstrated superior biological activity in reducing neovascularization and promoting retinal revascularization compared with either Wnt agonist or anti-VEGF monotherapy in a rodent model of retinal vascular disease. SZN-8141 also demonstrated greater reductions in vascular leakage than anti-VEGF therapy in a rodent model of neovascular age-related macular degeneration.

SZN-8141 will be evaluated in a Phase 1b/2a clinical trial in DME called DUET, designed to assess safety, tolerability, and early signs of biological and clinical activity. Surrozen expects to initiate the DUET Phase 1b/2a study in DME patients by year-end 2026, with initial data anticipated in the second half of 2027.

About SZN-8141 for Retinal Diseases 
Surrozen is developing SZN-8141 for the treatment of DME and neovascular age-related macular degeneration (wet AMD). SZN-8141 combines Frizzled 4 (FZD4)-mediated Wnt agonism and VEGF antagonism and has the potential to provide benefits over treatment with single mechanism agents against these targets. The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF therapies, including monotherapies and dual-pathway agents targeting VEGF and Ang-2. In addition, Merck’s MK-3000, a FZD4-mediated Wnt agonist monotherapy, has demonstrated proof of concept in DME in a clinical trial. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
About Surrozen
Surrozen is a biotechnology company, pioneering a new class of Wnt-based therapeutics designed to harness the power of Wnt signaling to treat sight-threatening ophthalmic conditions. Built on deep scientific expertise and a proprietary antibody-engineering platform, Surrozen develops multifunctional biologics that selectively activate Wnt signaling in combination with other key disease pathways. Our approach aims to deliver best-in-class, durable therapies that have the potential to transform patient outcomes in some of the most pressing unmet medical needs in ocular diseases. For more information, visit www.surrozen.com. 

Forward-Looking Statements 
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, such as the Company’s plan to initiate the DUET Phase 1b/2a study in DME patients by year-end 2026, the availability of data, such as initial data from the DUET study being anticipated in the second half of 2027, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates). These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for its product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2025, and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

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