Zhaoke Ophthalmology-B (06622) announced that on January 5, 2026, Australia's Therapeutic Goods Administration (TGA) has accepted for review the company's registration application for its Atropine Sulfate Eye Drops (0.01% dosage, product code: NVK002), intended for the treatment of myopia progression in children.
The TGA has formally notified the company that its application has passed the preliminary review and will proceed to a full evaluation.
This application is based on the supportive results obtained from the Phase III clinical trials conducted by the company.
Atropine Sulfate Eye Drops (NVK002) is an investigational novel topical ophthalmic solution for controlling the progression of myopia in children and adolescents.
Atropine Sulfate Eye Drops (NVK002) is a patented formulation that successfully addresses the instability issues of low-concentration atropine, a technology protected by intellectual property rights globally.
The Atropine Sulfate Eye Drops (NVK002) are preservative-free and are expected to have a shelf life of over 24 months.
According to information provided by China Insights Consultancy, NVK002 is currently one of the most advanced atropine candidates globally for treating myopia progression, targeting the broadest patient group covering children and adolescents aged 3 to 17.