Company News
SHENZHEN, China and Berkeley, Calif. — May 26, 2026 — Shenzhen Oculgen Biomedical Technology Co., Ltd. ("Oculgen"), a clinical-stage biotechnology company developing biologics for retinal disease, today announced the activation of its first U.S. clinical sites for the STAT study (STop ATrophy in AMD), a Phase 2/3 multicenter, randomized, masked, active comparator-controlled trial of OCUL101 in adults with neovascular age-related macular degeneration (AMD) with or without geographic atrophy (GA).
OCUL101 is an investigational, anti-VEGF and anti-complement C5, bi-specific humanized antibody-like "trap" administered by intravitreal injection. The molecule is being studied for its ability to bind two distinct mediators implicated in advanced AMD: VEGF, the central driver of choroidal neovascularization in "wet" AMD, and complement component C5, which has been associated with the inflammatory and atrophic changes characteristic of geographic atrophy.
The STAT study is designed to evaluate whether dual blockade of these pathways, delivered in a single intravitreal injection, produces a clinical profile distinguishable from current single-mechanism anti-VEGF therapy.
U.S. site activations follow regulatory clearance under FDA IND 173335. The global STAT program is planned across approximately 70 sites, including 46 sites in the United States and 24 sites in Europe.
"Activating our first U.S. sites is a significant operational milestone and reflects the strength of our partnerships with leading retinal investigators in the United States and Europe," said ChiungKuang Chen, PhD, Chief Executive Officer of Oculgen. "OCUL101 was designed to engage two pathways that are well-characterized contributors to AMD progression. STAT is the trial that will tell us whether engaging both, with one molecule, translates into a meaningful difference for patients."
"The unmet need in advanced AMD is well understood — patients on chronic anti-VEGF therapy live with treatment burden and remain at risk for atrophic progression, while patients on complement inhibitors face a measurable rate of de novo or rebound neovascularization," said Jay M. Stewart, MD, Professor of Clinical Ophthalmology at the University of California, San Francisco. "STAT is designed to assess, with appropriate scientific rigor, whether simultaneous blockade of VEGF and C5 can address both axes of disease in the same eye. We are grateful to the investigators bringing this study to their patients."
STAT is a Phase 2/3, multicenter, randomized, double-masked, active comparator-controlled, parallel-group, 96-week study evaluating the safety, efficacy, durability, and pharmacokinetics of two doses of OCUL101 compared with aflibercept 2 mg in approximately 255 participants with neovascular AMD with or without GA. The study is conducted in two parts:
• Part A (open-label safety lead-in, n=5) evaluates the 10.4 mg High Dose (HD) of OCUL101 administered intravitreally every 4 weeks for three doses, followed by every 8 weeks through Week 36, then PRN through Week 96.
• Part B randomizes approximately 250 participants into four treatment arms evaluating two dose levels and multiple dosing regimens of OCUL101 compared with aflibercept 2 mg.
The primary efficacy endpoint is change from baseline in mean best-corrected visual acuity (BCVA) on the ETDRS chart at Week 36 compared with aflibercept 2 mg, assessed for non-inferiority at a 4.5-letter margin. Secondary endpoints include central subfield thickness on SD-OCT, proportion of participants gaining ≥15 ETDRS letters, change in choroidal neovascularization lesion size on fluorescein angiography and color fundus photography, and change in geographic atrophy lesion size on fundus autofluorescence. An independent Data Monitoring Committee (iDMC) provides ongoing safety oversight.
Week 36 efficacy and safety data are intended to support the Biologics License Application; the study continues to Week 96 for durability and longer-term safety assessment.
Study information is available at ClinicalTrials.gov under identifier [NCT07520318]. Patients interested in clinical trial participation should consult with their retina specialist.
OCUL101 is an investigational humanized, bi-specific antibody-like "trap" engineered to bind VEGF-A and complement component C5. It is administered by intravitreal injection and is being evaluated at two dose levels (6.5 mg / 50 µL and 10.4 mg / 80 µL) on dosing regimens designed to assess every-8-week or extended PRN intervals after a three-dose loading phase. OCUL101 has not been approved by any regulatory authority for any indication.
Shenzhen Oculgen Biomedical Technology Co., Ltd. is a clinical-stage biotechnology company focused on developing bi-specific and multi-specific biologics for serious retinal and ophthalmic diseases. The company is advancing OCUL101 under FDA IND 173335, NMPA INDs 2025LP00090 / 2025LP00091 / 2025LP00092, and corresponding European regulatory authorizations. For more information, visit www.oculgen.com.
info@oculgen.com
Naveed Shams, MD, PhD Medical Monitor, STAT Study naveed@oculgen.com.cn +1 707-812-3866
Forward-looking statements
This press release contains forward-looking statements regarding the clinical development of OCUL101, the design, conduct, and timing of the STAT study (OCUL101-002), and Oculgen’s planned regulatory submissions. These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to clinical trial enrollment results, and timing; safety findings; manufacturing and supply; regulatory review by the U.S. Food and Drug Administration, the European Medicines Agency, China’s National Medical Products Administration, and other authorities; intellectual property; competition; and the company’s financial resources. Oculgen undertakes no obligation to update these forward-looking statements except as required by law.
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