Zhaoke Ophthalmology Limited has announced positive top-line results from its Phase III clinical trial of TAB014 for the treatment of wet (neovascular) age-related macular degeneration (wAMD). The study, a randomized, double-blind, non-inferiority trial, successfully met its primary endpoint and key secondary endpoints, marking a significant advancement in ophthalmic treatment innovations in China.
The trial enrolled approximately 488 patients across 57 centers, led by Professor Chen Youxin from Peking Union Medical College Hospital. The primary objective was to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in the TAB014-treated group compared to the Lucentis-treated group.
Mechanism of Action
TAB014 is a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody formulated for ophthalmic use. wAMD is characterized by choroidal angiogenesis in the macula, with VEGF playing a crucial role in this process. TAB014 is designed to specifically bind to VEGF, preventing it from binding to its receptors and thereby inhibiting angiogenesis. The drug is intended for intravitreal injection.
Clinical and Commercial Strategy
Zhaoke Ophthalmology has secured full control over the clinical development and commercialization of TAB014 in China, Hong Kong, and Macau through an agreement with TOT BIOPHARM. This positions TAB014 as a potentially cost-effective solution in the rapidly growing market for wAMD treatments.
Current Treatment Landscape
The current standard of care for wAMD often involves anti-VEGF therapies, which, while effective, can be costly. TAB014 aims to provide a more accessible option, potentially reducing the economic burden on patients and healthcare systems.
