According to the company, the Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial, with 18 subjects, who each have received a single periocular injection of AIV007.¹

The participants will be evaluated monthly for up to 6 months to assess tolerability, safety, reduction of treatment burden, and biological activity.

Diane Tang-Liu, PhD, CEO, president, and co-founder of AiViva Biopharma, noted in a news release that the full enrollment in the company’s Phase 1 safety trial in the US marked a milestone.

“AIV007 (lenvatinib) is a broad-spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation,” she said in the news release. “We believe AIV007, formulated with our proprietary JELtechnology and administered periocularly, has the potential to address the root causes of wet AMD, DME, and many other ocular diseases.”

Tang-Liu added that the company is on target to have the study completed, and full results available in Q1 2025.

Reference:

1. AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema. GlobeNewswire. Published August 23, 2024. Accessed August 23, 2024.