AiViva Biopharma has announced the completion of enrollment and dosing for all participants in its Phase 1 clinical trial evaluating AIV007 for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). This multi-center, open-label, dose-escalation safety trial aims to assess the safety and tolerability of AIV007, a novel tyrosine kinase inhibitor, administered via periocular injection.
The Phase 1 trial enrolled 18 participants who each received a single periocular injection of AIV007. These participants will be monitored monthly for six months to evaluate the drug's safety profile. The company anticipates having the complete study results available in the first quarter of 2025.
AIV007: A Novel Approach to AMD and DME
AIV007 (lenvatinib) is designed as a broad-spectrum tyrosine kinase inhibitor that targets the convergence of fibrosis, angiogenesis, and inflammation, key factors in the pathology of wet AMD and DME. According to Diane Tang-Liu, PhD, AiViva’s CEO, president, and co-founder, AIV007, formulated with AiViva's proprietary JEL technology and administered periocularly, has the potential to address the root causes of wet AMD, DME, and other ocular diseases.
Current Treatment Landscape and Unmet Needs
Wet AMD and DME are leading causes of vision loss worldwide. Current treatments often involve repeated intravitreal injections of anti-VEGF (vascular endothelial growth factor) agents, which can be burdensome for patients. AIV007's unique mechanism of action and potential for less frequent administration via periocular injection could represent a significant advancement in the treatment of these conditions, if proven safe and effective.
Trial Design and Endpoints
The Phase 1 trial is designed as a multi-center, open-label, dose-escalation study. The primary endpoint is the assessment of safety and tolerability of a single periocular injection of AIV007. Participants will be evaluated monthly for adverse events and changes in visual acuity over a six-month period.
