Sydnexis Submits NDA for SYD-101, Potentially First FDA-Approved Drug to Slow Pediatric Myopia Progression

Sydnexis announced today that the U.S. FDA has accepted the company's New Drug Application (NDA) for its investigational therapy SYD-101, with the review expected to be completed by October 23, 2025. The press release noted,If approved, SYD-101 will become the first drug approved by the US FDA for the treatment of myopia progression in children.

▍AboutSYD-101

The NDA submission is based on the primary and secondary endpoint data from the Phase 3 clinical trial, the STAR study. The study aims to evaluate the efficacy of SYD-101 in slowing the progression of myopia in children and reducing the risk of related complications.SYD-101 is an investigational low-dose atropine sulfate ophthalmic solution designed to achieve therapeutic efficacy for pediatric myopia while enhancing pharmacological stability and reducing discomfort to improve treatment continuity.SYD-101 does not require pH reduction and can maintain a shelf life of up to 3 years at room temperature.

▍The Number of Clinical Trials on Low-Concentration Atropine is Increasing

According to the American Academy of Ophthalmology's research on low-concentration atropine for myopia progression, 0.025% atropine eye drops slowed myopia progression and were well-tolerated in children without any adverse reactions.0.025% Atropine Sulfate Eye Drops Are Recommended as the Initial Dose for Myopia Treatment, Suitable for Children with Myopia.This helps balance the side effects and efficacy of 0.01% concentration atropine and allows for an increase in concentration to control progressive myopia when needed.

On March 11, 2024, the official website of the National Medical Products Administration released a message,Shenyang Xingqi Eye Medicine Co., Ltd. ("Xingqi Eye Medicine") has received approval for the market launch of its 0.01% Atropine Sulfate Eye Drops on March 5th, which will be used to slow the progression of myopia in children and adolescents.Currently, there are no similar products for myopia-related indications available in China. Sydnexis recently told the media that its internet hospital is expected to launch on March 24, when patients will be able to consult with doctors and get prescriptions online.

Global Low-Concentration Atropine Market Suppliers (Manufacturers) Focus on Developing New Treatments for Myopia. Increased R&D expenditure and clinical research by traditional pharmaceutical and biopharmaceutical companies have supported the advancement of innovative ocular therapies. Below are some ongoing clinical trials:

• October 2023,Vyluma announced the results of its CHAMP (Childhood Atropine for Myopia Progression) Phase 3 clinical trial,The study tested the efficacy of its low-dose atropine solution, NVK002. The New Drug Application for NVK002 is currently under review by the FDA, which has set the PDUFA goal date for NVK002 as January 31, 2024.

• May 2022,ENTOD INTERNATIONAL Receives Approval from India's Drug Controller General (DCGI)Can conduct phase III clinical trials of its 0.05% atropine eye drops for treating eye problems across India.

• Sydnexis (global multicenter), Qilu Pharmaceutical, and many other pharmaceutical companies in Chinaare also conducting Phase III clinical trials.

These developments and the increase in the number of clinical trials are expected to drive the growth of the global low-concentration atropine market during the forecast period.

Source: WuXi AppTec, China Newsweek, Qingbai Perspective