AiViva Biopharma completes patient enrollment in phase 1 trial of AIV007 for age-related macular degeneration and diabetic macular edema
Overview
AiViva Biopharma Inc., a clinical-stage biotechnology company, announced that it has fully enrolled and completed dosing the last patient in a phase 1 trial with wet age-related macular degeneration (wAMD), and/or diabetic macular edema (DME). “We have achieved a major milestone, full enrollment in our phase 1, safety trial in the US” said Diane Tang-Liu, PhD, CEO, president & co-founder of AiViva Biopharma. “AIV007 (lenvatinib) is a broad-spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation. We believe AIV007, formulated with our proprietary JEL technology and administered periocularly, has the potential to address the root causes of wet AMD, DME and many other ocular diseases. We are on target to have the study completed, and full results Q1 2025.
Phase I Trial
This phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial, with 18 subjects, who have received a single periocular injection of AIV007 and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, biological activity, and the reduction of treatment burden.
Age-Related Macular Degeneration
- AMD is a progressive retinal disease that is the leading cause of blindness in adults over the age of 60, affecting up to 15 million US people.
- AMD affects the macular, center portion of the retina, that is responsible for central vision and color perception.
- In patients with wet AMD vision loss is caused by abnormal blood vessels leaking fluid and blood into and beneath the retina.
Diabetic Macular Edema
- Diabetic macular edema is manifested as retinal thickening and swelling caused by accumulation of intraretinal fluid usually due to blood sugar levels being consistently high.
- If untreated, chronic macular edema can lead to irreversible damage of the macula and permanent vision loss.
About AiViva
- AiViva is a clinical stage biotech company led by a team of seasoned industry experts with proven track record in drug development and commercialization.
- AiViva has developed innovative approaches to address high unmet medical needs through focal therapies that target diseases of neovascularization, abnormal cell proliferation, and fibrosis.
