【Press Release】Oculgen Announces Initiation of Phase II Clinical Trials for Novel Bispecific Antibody OCUL101 Worldwide

Shenzhen Oculgen Biomedical Technology Co., Ltd (Oculgen) announces the planned global initiation of Phase II clinical trials for its novel bispecific antibody, OCUL101. OCUL101 is the world’s first dual-mechanism antibody targeting three blinding retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and geographic atrophy (GA).

Oculgen has successfully completed the Phase 1b multiple ascending dose (MAD) high-dose cohort of monthly intravitreal (IVT) injections in China, part of its ongoing Phase 1b/2 trial for nAMD in China. All patients in P1b trial had a medical history of multiple prior anti-VEGF intravitreal injections for nAMD. The Phase 1b cohort completion has provided valuable safety and efficacy data to support the advancement to Phase II trials.

Early clinical data for OCUL101 is encouraging: it has demonstrated a favorable safety profile in both single ascending dose (SAD) and MAD studies, with no dose-limiting toxicities, serious adverse events, or vision-threatening complications reported. A single high dose of OCUL101 has shown durability beyond 17 weeks, and repeated dosing has suggested enhanced visual superiority in BCVA and anatomical outcomes compared to aflibercept (Eylea).

Oculgen received acceptance from both CDE and the U.S. FDA in February 2026 to initiate the Phase II trials. Its global Phase II program will include three trials in China (covering nAMD, DME, and China’s first biologic Phase 2 trial for GA) and a parallel nAMD Phase II trial in the United States, establishing a worldwide clinical footprint.

Oculgen plans to initiate all Phase 2 trial activities in China and the U.S. starting in April 2026, after which its global clinical program will be fully operational. This effort aligns with Oculgen’s commitment to evaluate OCUL101’s potential and bring hope to patients with these retinal conditions.