Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA declined to approve SYD-101, a low-dose atropine formulation that would have been the first pharmaceutical treatment for slowing the progression of pediatric myopia in the U.S., according to a press release from Sydnexis.
SYD-101 is a 0.01% atropine formulation that is designed for “enhanced ocular tissue permeability” and stable at room temperature for up to 3 years, according to the company.
The FDA wrote in its complete response letter that although the drug met its primary efficacy