Zhaoke Ophthalmology Limited announced the top-line results from its one-year Phase III clinical trial (" Mini-CHAMP") of one of the Company's core products, NVK002. Analysis of this multi-center study, performed after one year of treatment, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children, and indicates consistent trends with the Phase III CHAMP clinical study performed by the Company's US partner, Vyluma Inc. ("Vyluma") during its first year. Phase III Mini-CHAMP is a randomized, double-masked, placebo-controlled, multi-center clinical study.

The main objective is to evaluate the efficacy and safety of NVK002 in slowing the progression of myopia in Children and adolescents in China. The trial involved 16 centers and enrolled 526 children and adolescents, co-led by Professor Qu Xiao Mei from Eye and ENT Hospital of Fudan University and Professor Yang Xiao from Zhongshan Ophthalmic Center, Sun Yat-Sen University as the Principal Investigators. The study consists of two stages: a one-year treatment period to evaluate the safety and efficacy of NVK002, after which enrolled patients are re-randomized for a masked, one-year treatment period to characterize cessation of therapy.

Mini-CHAMP successfully met its primary efficacy endpoint with both doses of 0.01% and 0.02% NVK002 achieving statistically and clinically meaningful differences versus placebo in terms of slowing myopia progress in the study population. NVK002 at both doses were well tolerated and safe as reflected by the low treatment discontinuation rates and low ocular serious adverse events (SAEs) respectively. The Company plans to communicate with regulatory authorities to advance the process of New Drug Application ("NDA") for NVK002 in China combining the results from Mini-CHAMP with Vyluma's data from Phase III CHAMP study.

The Company has been conducting a parallel two-year Phase III clinical trial ('China CHAMP). The China CHAMP trial involved 18 centers and enrolled 777 patients. Patient enrollment was completed on July 21, 2022.

On October 11, 2023, Vyluma announced positive top-line results from the second stage of its Phase III CHAMP clinical study NVK002. Analysis of the results of this multi-center, international study conducted after four years of treatment and follow up, show continued strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as an potential treatment for myopia in children.