Oculgen Announces First U.S. Patient Enrolled in STAT Study of OCUL101 for Neovascular AMD

SHENZHEN, China and Los Angeles, California — June 19, 2026 — Shenzhen Oculgen Biomedical Technology Co., Ltd. (“Oculgen”) today announced that the first U.S. participant has been enrolled in the STAT study (ClinicalTrials.gov Identifier: NCT07520318), a Phase 2/3 clinical trial evaluating the investigational agent OCUL101 in adults with treatment-naïve neovascular (“wet”) age-related macular degeneration (nAMD).

About OCUL101

OCUL101 is an investigational, humanized, bispecific antibody-like “trap” administered by intravitreal injection. It is being studied for its ability to bind two distinct mediators implicated in AMD: VEGF, a central driver of choroidal neovascularization in neovascular (“wet”) AMD, and complement C5, a component of the complement cascade associated with the inflammatory and atrophic processes seen in age-related macular degeneration.

Approved anti-VEGF therapies target neovascularization but are not indicated to prevent atrophic progression. The scientific rationale for OCUL101 is to engage both pathways with a single molecule; whether this approach offers clinical benefit is the subject of ongoing investigation and has not been established.

About the STAT Study

STAT (STop ATrophy in AMD) is a Phase 2/3, multicenter, randomized, double-masked, active comparator-controlled, 96-week study evaluating two dose levels of OCUL101 compared with aflibercept 2 mg in approximately 255 participants. The study is registered on ClinicalTrials.gov (NCT07520318). Pre-specified Week 36 efficacy and safety data are intended to inform a future Biologics License Application (BLA).

The first U.S. enrollment was completed at a participating clinical site in Los Angeles, California— a key operational milestone for the global STAT program. U.S. site activation followed clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The global STAT program is planned across approximately 70 sites, including 46 sites in the United States and 24 sites in Europe.

Acknowledgements

Oculgen is grateful to the participants who are contributing to this research and to the investigators, study coordinators, and site staff across the United States and Europe. Enrollment is ongoing, and the company looks forward to sharing further progress.

About Oculgen

Oculgen is a clinical-stage biotechnology company focused on developing bispecific and multi-specific biologics for serious retinal and ophthalmic diseases. For more information, visit www.oculgen.com.

Important Information About Investigational Use

OCUL101 is an investigational agent that has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Its safety and efficacy have not been established. This communication is intended to describe the conduct and progress of a clinical trial and is not an offer, promotion, or advertisement of OCUL101, and it should not be interpreted as a recommendation to use, prescribe, or seek any investigational product. Decisions about participation in a clinical trial should be made in consultation with a qualified healthcare professional and are governed by the IRB-approved informed consent process.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the design, conduct, timing, and anticipated milestones of the STAT study and the potential regulatory pathway for OCUL101. These statements are based on current expectations and are subject to risks and uncertainties — including those relating to clinical development, enrollment, the outcome of ongoing and future studies, and interactions with regulatory authorities — that could cause actual results to differ materially. Forward-looking statements speak only as of the date of this release, and Oculgen undertakes no obligation to update them except as required by law.

Contacts

Media and investor inquiries

info@oculgen.com

Medical / scientific inquiries

Naveed Shams, MD, PhD

Medical Monitor, STAT Study

naveed@oculgen.com.cn

+1 707-812-3866