Key Takeaways

  • The first US participant has been enrolled in the phase 2/3 STAT trial evaluating OCUL101 for treatment-naïve wet AMD
  • OCUL101 is a dual-target investigational biologic designed to bind both VEGF and complement C5, addressing angiogenic and inflammatory pathways implicated in AMD
  • The global study plans to enroll approximately 255 participants across 70 sites in the United States and Europe

Shenzhen Oculgen Biomedical Technology Co. (Oculgen) announced that the first US participant has been enrolled in the phase 2/3 STAT study (NCT07520318), which is evaluating the investigational agent OCUL101 in adults with treatment-naïve wet age-related macular degeneration (AMD).

The STAT study, short for STop ATrophy in AMD, is a multicenter, randomized, double-masked, active comparator-controlled trial designed to evaluate the efficacy and safety of two dose levels of OCUL101 compared with aflibercept 2 mg. The study is expected to enroll approximately 255 participants and will follow patients for 96 weeks. The global STAT program is expected to include approximately 70 clinical sites, comprising 46 sites in the United States and 24 sites across Europe. 

According to Oculgen, pre-specified efficacy and safety data collected through Week 36 are intended to support future regulatory discussions and may inform a planned Biologics License Application submission.

The enrollment marks a milestone for the global development program and follows clearance of Oculgen's investigational new drug application by the FDA. The first US participant was enrolled at a clinical site in Los Angeles.

OCUL101 is an investigational humanized bispecific antibody-like trap administered by intravitreal injection. The agent is designed to target two biological pathways implicated in AMD by binding vascular endothelial growth factor (VEGF) and complement component C5, which has been associated with inflammatory and atrophic processes in the disease.

According to Oculgen, current anti-VEGF therapies are effective at controlling neovascularization but are not approved to prevent retinal atrophy. OCUL101's dual-target mechanism is intended to address both angiogenic and complement-mediated pathways with a single therapeutic molecule. However, the clinical benefit of this approach remains under investigation and has not yet been established.