GOOD NEWS丨Yeedozencom assisted Singqi in the approval of 0.01% atropine sulfate eye drops
Atropine sulfate eye drops is an ophthalmic preparation with atropine sulfate as the active ingredient. It is one of the drugs proved by evidence-based medicine to be effective in slowing the progression of myopia. As a domestic ophthalmology pioneer, Singqi Ophthalmology signed a cooperation agreement with the National Eye Centre of Singapore (SNEC) in June 2016. In 2019, Sinqi reached an in-depth cooperation with Yeedozencom to carry out phase III clinical trials on the effectiveness and safety of the product in delaying the progression of myopia in children.
In October 2019, Yeedozencom also organized and held the first investigator meeting and project initiation meeting to deeply discuss the design and implementation of the project, and completed the first subject enrollment in July 2020.
It lasted for 2 years, and a total of 406 subjects completed follow-up observation and obtained positive results, and there were statistically significant differences between the treatment group and the control group in the key efficacy indicators, and the treatment group was superior to the control group, effective as single agent and safe in the long term. In May 2023, after the expert validation meeting of accelerated approval application approved, Atropine Sulfate Eye Drops was approved as a new variety to delay the progression of myopia in children with obvious clinical advantages, and was included in the priority review and approval process.
On March 11, 2024, according to the official website of NMPA, Atropine Sulfate Eye Drops was approved for marketing (Acceptance Number.: CXHS2300047), which is formally used to delay the progress of myopia in children. The approval of it will further establish Singqi 's leading position in the ophthalmic industry and have a far-reaching impact on China's and even the global youth myopia market.
