AiViva Biopharma Completes Phase 1 Enrollment for AIV007 in AMD and DME

AiViva Biopharma Inc., a clinical-stage biotechnology company, has announced the successful completion of patient enrollment and dosing in its Phase 1 trial for treating wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Diane Tang-Liu, PhD, CEO, President & Co-Founder of AiViva Biopharma, emphasized the significance of this advancement, stating, “We have accomplished a crucial milestone with the full enrollment in our Phase 1 Safety Trial in the U.S.” The investigational drug, AIV007 (lenvatinib), is a broad-spectrum tyrosine kinase inhibitor that addresses fibrosis, angiogenesis, and inflammation. Administered periocularly and formulated with AiViva's proprietary JEL™ technology, AIV007 has the potential to treat the underlying causes of wAMD, DME, and other ocular diseases. The company anticipates completing the study and sharing full results by the first quarter of 2025.

The Phase 1 trial, which is multicenter and open-label, focuses on dose-escalation safety and involves 18 subjects who have all received a single periocular injection of AIV007. These participants will be monitored monthly for up to six months to evaluate safety, tolerability, biological activity, and the reduction of treatment burdens.

Age-related macular degeneration (AMD) is a progressive retinal disorder that stands as the primary cause of blindness among adults over 60, impacting up to 15 million individuals in the United States. AMD targets the macula, the central part of the retina responsible for central vision and color perception. In cases of wet AMD, vision impairment is caused by abnormal blood vessels leaking fluid and blood into and beneath the retina. Diabetic macular edema manifests as retinal thickening and swelling due to the accumulation of intraretinal fluid, typically resulting from persistently high blood sugar levels. If not treated, chronic macular edema can cause irreversible damage to the macula and permanent vision loss.

AiViva Biopharma is led by a team of experienced industry professionals with a proven track record in drug development and commercialization. The company focuses on addressing significant unmet medical needs through targeted therapies for diseases related to neovascularization, abnormal cell proliferation, and fibrosis. AiViva’s core strengths lie in developing novel drugs using proprietary technologies, including JEL™, across various specialty therapeutic areas such as ophthalmology, dermatology, urology, and oncology.