Sydnexis Inc. announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States, the company said in a press release. 

The NDA application is based on 3-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities.

“SYD-101’s novel, proprietary formulation was uniquely designed to deliver superior drug activity, maximum stability, and optimal comfort,” said Patrick Johnson, PhD, president at Sydnexis, in the press release. “We knew we wanted to evaluate SYD-101 in a very robust study. Our landmark STAR Study is the largest clinical study ever completed for the treatment of progression of pediatric myopia, enrolling more than 850 patients across a broad patient population of 3- to 14-year-olds.”