AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema
Novel JEL™ Technology for Periocular Administration
COSTA MESA, Calif., Aug. 23, 2024 (GLOBE NEWSWIRE) -- 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 U.S." 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."
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.
About Age-Related Macular Degeneration and Diabetic Macular Edema
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.
About AiViva Biopharma, Inc.
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. Core competencies include development of novel drugs using proprietary technologies, including JEL™, in specialty therapeutic areas of ophthalmology, dermatology, urology and oncology. Please visit www.aiviva.com to learn more.
Contact:
AiViva Biopharma
office@aiviva.com
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