US-based biotechnology firm AiViva Biopharma has begun a Phase I clinical trial of AIV007 for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME).
The company has finished dosing the first cohort of patients diagnosed with wAMD and DME.
The open-label dose-escalation safety trial will enrol up to 24 subjects across multiple sites to receive a single periocular injection of AIV007.
AIV007’s safety, tolerability and efficacy as measured by best corrected visual acuity (BCVA) will be evaluated each month for six months.
AiViva Biopharma CEO, president and co-founder Diane Tang-Liu said: “We are very excited to have initiated this US trial.
“AIV007 is a broad spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation.
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“We believe AIV007 coupled with our proprietary JEL™ technology and administered periocularly, will address the root causes of many ocular diseases.”
AiViva Biopharma’s JEL technology is also used in developing new drugs in various therapeutic areas such as oncology, urology and dermatology.
AMD is a progressive retinal disease that causes loss of vision due to the leakage of fluid and blood from the abnormal blood vessels into and beneath the retina.
The disease affects the central macular portion of the retina, which is responsible for central vision and colour perception.
An estimated 15 million adults aged older than 60 years in the US suffer from AMD.
DME is caused due to the accumulation of intraretinal fluid, usually because of high blood sugar levels.
If left untreated, the condition becomes chronic, leading to permanent vision loss and irreversible damage to the macula.
Founded in 2015, AiViva Biopharma develops focal therapies that target diseases of neovascularisation, abnormal cell proliferation and fibrosis.
The company focuses on developing drugs for ophthalmology, dermatology, urology and oncology using JEL and other proprietary technologies.