The FDA has accepted an NDA for SYD-101, a proprietary low-dose atropine formulation developed to slow paediatric myopia progression. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025.
The NDA is supported by data from the pivotal STAR Study, a phase III clinical trial enrolling over 850 children aged 3 to 14. This trial was designed as a 5-arm, multicenter, randomized, double-masked, vehicle-controlled study and the primary outcome measure was the proportion of participants experiencing confirmed myopic progression greater than 0.75 diopters (D), based on spherical equivalent measurements obtained through cycloplegic autorefraction at 36 months.
A recent report estimates that myopia currently affects approximately 30.47% of the global population and projects that by 2050, it will impact around 740 million children and adolescents worldwide. According to the report, genetics contribute significantly to myopia development, meaning children may inherit a predisposition from their parents. However, the report also emphasizes environmental factors, particularly the increased use of screens and digital devices, as important contributors to the rising prevalence of myopia.
If approved, SYD-101 would represent the first FDA-approved pharmaceutical therapy specifically targeting paediatric myopia progression in the United States. The FDA’s decision on SYD-101 is expected by October 23, 2025.
References:
Register now to receive the touchOPHTHALMOLOGY newsletter!
Don’t miss out on hearing about our latest peer reviewed articles, expert opinions, conference news, podcasts and more.
