Oculgen Completes Enrollment Ahead of Schedule in China Phase II DME Study

Shenzhen, China and California, USA – July 22, 2026 – Oculgen Biomedical Technology Co., Ltd. ("Oculgen") today announced a major milestone in the global development of its First-in-Class anti-VEGF-Complement C5 bispecific fusion protein ophthalmic drug, OCUL101. The company has completed enrollment of all 120 patients in its randomized China Phase II clinical trial in Diabetic Macular Edema (DME), completing enrollment within 3 months, ahead of projected timeline.

This milestone reflects strong investigator and patient enthusiasm, efficient clinical execution, and growing conviction in OCUL101’s differentiated mechanism of action as the global development program continues to expand across DME, neovascular Age-related Macular Degeneration (nAMD) and Geographic Atrophy (GA).

First Human Clinical Evidence Supporting Dual VEGF/C5 Inhibition

The rapid advancement of OCUL101 is supported by encouraging data from its Phase Ib clinical study in patients with previously treated nAMD. The study demonstrated a favorable safety profile across all dose levels, with no dose-limiting toxicities, retinal vasculitis, intraocular inflammation, or treatment-related serious adverse events. Improvements in Best Corrected Visual Acuity (BCVA) and Central Retinal Thickness (CRT) were observed in a dose-dependent manner following single administration and were sustained after three monthly injections. At Week 20 of MAD stage after 3 of loading administrations, BCVA gains were numerically greater than aflibercept, with 44% of OCUL101-treated patients gaining ≥8 ETDRS letters versus none with aflibercept. Clinical benefit persisted up to 7 months in selected patients. Together, these findings provide the first human clinical evidence supporting dual VEGF/C5 inhibition in nAMD and establish scientific foundation for Oculgen’s expanding global Phase II clinical programs.

Global Phase II Development Program Acceleration

The early completion of DME Phase II enrollment in China marks another important milestone in the Company’s comprehensive retinal disease development strategy. 

This multi-center, randomized, double-masked, active-controlled study (CTR20250853) enrolled 120 patients, comparing OCUL101 6.5 mg (n=40), OCUL101 10.4 mg (n=40) and Vabysmo^® 6 mg (n=40). The study is designed to evaluate safety, preliminary efficacy, optimal dosing, and treatment intervals to support subsequent Phase III development.

Oculgen’s global Phase II development programs are now progressing simultaneously across three major indications:

• DME: The China Phase II study has completed enrollment ahead of schedule, with patient follow-up and data analysis underway.

• nAMD: The U.S. Phase II/III STAT study has enrolled its first patient, while Phase II study in China continues to enroll rapidly, with approximately 50% enrollment completed.

• GA: China’s first biologic Phase II trial for GA has completed study initiation activities and is poised to begin patient  enrollment in August 2026.

Addressing Three Major Retinal Indications with a Single Therapeutic Entity

Retinal diseases remain among the leading causes of irreversible vision loss worldwide. While Anti-VEGF therapy has transformed treatment for nAMD and DME, many patients continue to require frequent intravitreal injections and experience incomplete responses. GA on the other hand, lacks effective treatment options, leaving millions of patients in China with no available therapy.

OCUL101 is the world's first anti-VEGF-Complement C5 bispecific fusion protein specifically to simultaneously inhibit angiogenesis, vascular leakage, and complement-mediated inflammation. By targeting two complementary disease pathways within a single molecule, OCUL101 has the potential to deliver broader disease control and improved durability across multiple retinal disorders.

Dr. Chiung-Kuang Chen, Founder, Chairman, and CEO of Oculgen, commented: 

"Completing enrollment in our DME Phase II study 3 months ahead of projected timeline is a significant milestone for the OCUL101 program and reflects both the enthusiasm of investigators and the urgent need for innovative retinal therapies that move beyond VEGF inhibition alone. Combined with encouraging Phase I safety, efficacy and durability, this achievement reinforces our conviction in dual VEGF/C5 inhibition and accelerates our global development strategy across nAMD, DME and GA. We are grateful to the patients, investigators and the clinical teams whose commitment continues to advance this important program.”   

About Shenzhen Oculgen Biomedical Technology Co., Ltd.

Oculgen is dedicated to the field of large-molecule innovative ophthalmic drugs, committed to developing first-in-class therapies for major retinal diseases including nAMD, DME, and GA through independent R&D, with the goal of addressing unmet medical needs of patients worldwide. The company has built end-to-end capabilities spanning from target discovery to commercial development, and has established a multi-tiered product pipeline covering a broad spectrum of retinal disorders, forming a differentiated portfolio. Oculgen will continue to accelerate its global R&D efforts to bring its therapies to patients as soon as possible.

For more information, please visit: www.oculgen.com

Forward-Looking Statements

This press release contains forward-looking statements based on current expectations and assumptions, which involve known and unknown risks and uncertainties. Actual results may differ materially from those expressed in these forward-looking statements. The Company undertakes no obligation to update these forward-looking statements.