Sydnexis, Inc. announced the US Food and Drug Administration (FDA) issued a complete response letter (CRL) for the new drug application (NDA) for SYD-101, the company's proprietary 0.01% atropine formulation developed to slow the progression of pediatric myopia in children. Specifically, the FDA says that the data do not support the effectiveness of low-dose atropine in children with myopia. 

Sydnexis’ NDA for SYD-101 was supported by the results of the phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial, comprised of more than 800 children ages 3-14 at treatment initiation. Specifically, the study met its primary efficacy endpoint of proportion of patients with confirmed myopia progression of -0.75D, which the FDA had encouraged the company to use, according to a company-issued press release. A key secondary endpoint, annual myopia progression rate, also met statistical significance at 12, 24, and 36 months, according to Sydnexis. In a subgroup of fast progressors [more than -0.5D/yr] at 36 months, the company says SYD-101 demonstrated a reduction in progression of more than 50%.

“While we are surprised and disappointed with this decision, Sydnexis is committed to working with the FDA to address the items outlined in the CRL and determining the best path forward toward approval for SYD-101,” says Perry Sternberg, chief executive officer of Sydnexis. “Our goal is to provide eyecare professionals in the United States with the first FDA-approved option to help slow the progression of pediatric myopia, rather than continued reliance on compounded formulations of atropine. We remain confident in our data and the potential of SYD-101 to fill a critical innovation gap and treat the most common eye disease in children.” OM