【Press Release】Oculgen Launches U.S. Phase II/III STAT Study to Advance Treatment for Neovascular Age-Related Macular Degeneration (nAMD)

First clinical sites initiated and ready to enroll participants

Shenzhen, China — May 5, 2026 — Oculgen Biomedical Technology Company Limited today announced the U.S. launch of the STAT Study (STop ATrophy in AMD), a Phase II/III clinical trial evaluating OCUL101 for the treatment of neovascular age-related macular degeneration (nAMD), with or without geographic atrophy (GA). Study clinical sites are now activated and prepared to enroll the participants.The STAT Study is a multicenter, randomized, masked, active comparator-controlled trial designed to assess the safety and efficacy of two dose levels of OCUL101. OCUL101 is an investigational bi-specific antibody engineered to simultaneously inhibit vascular endothelial growth factor (VEGF) and complement component C5—two key pathways implicated in vision loss and disease progression in AMD.

Despite advances in anti-VEGF therapy, many patients with nAMD continue to experience suboptimal outcomes, particularly those with poor response to current existing treatments and coexisting geographic atrophy. “By targeting both VEGF and complement-mediated inflammation, OCUL101 represents a promising approach to address multiple drivers of disease. The launch of the STAT Study marks an important milestone as we work to bring forward new options for patients.”

Age-related macular degeneration is a leading cause of vision loss worldwide. While anti-VEGF therapies have improved outcomes for many patients with nAMD, there remains a significant unmet need, especially for those with concurrent GA or inadequate response to current treatments.

The STAT Study will be conducted across multiple clinical sites in the United States, with additional regions planned in subsequent phases. The study will evaluate visual outcomes, retinal anatomy, and safety across treatment arms, with the goal of determining whether dual-pathway inhibition can improve and sustain vision outcomes while addressing disease progression.

Study Highlights

Study Product: OCUL101

Development Phase: Phase II/III

Design: Multicenter, randomized, masked, active comparator-controlled

Indication: Neovascular AMD with or without geographic atrophy

Status: Study enrollment initiating in the U.S.

About OCUL101

OCUL101 is an investigational, bi-specific humanized antibody designed to inhibit both VEGF and complement C5. By targeting angiogenesis and complement-driven inflammation, OCUL101 aims to provide a differentiated approach for the treatment of retinal diseases such as nAMD.

About Oculgen Biomedical Technology Company Limited

Oculgen Biomedical Technology Company Limited is a clinical-stage biotechnology company focused on developing innovative therapies for ophthalmic diseases. The company is committed to advancing treatments that address significant unmet medical needs and improve outcomes for patients with vision-threatening conditions.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development and potential benefits of OCUL101 and the STAT Study. These statements are subject to risks and uncertainties, and actual results may differ materially. Oculgen undertakes no obligation to update these statements except as required by law.

Media Contact:

Juliette Bridges

Sr. Director

Oculgen Biomedical Technology Company Limited

info@oculgen.com

www.oculgen.com