According to the company, the Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial. Up to 24 subjects will receive a single periocular injection and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, and efficacy measured by best corrected visual acuity.

(Image Credit: AdobeStock/Eugene)

AiViva Biopharma Inc. announced that it has begun a Phase 1 trial and completed dosing the first cohort of patients diagnosed with wet age-related macular degeneration (wAMD), and/or diabetic macular edema (DME).

“We are very excited to have initiated this U.S. trial,” Diane Tang-Liu, PhD, CEO, president and co-founder of AiViva Biopharma, said in a news release. “AIV007 is a broad spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation. We believe AIV007 coupled with our proprietary JEL technology and administered periocularly, will address the root causes of many ocular diseases.”

About AMD and DME

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 U.S. 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 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.