Sydnexis setback highlights FDA’s  lack of transparency, concerns about shifting goalposts

The fallout from a complete response letter FDA recently sent to Sydnexis for SYD-101, its pediatric myopia treatment, embodies the frustrations that have swirled around the agency for years and have intensified since January: shifting approval goalposts, inconsistent evidentiary requirements across divisions and centers, disconnects between FDA’s interpretation of a disease and the clinical consensus, and limited transparency.

FDA’s CRL to Sydnexis Inc. for SYD-101, a low-dose atropine therapy for pediatric myopia, has stunned clinicians who treat the condition. Editorials in medical journals have called the rejection “baffling” and “puzzling,” and physicians’ reactions have ranged from “rage to disbelief,” according to the Review of Optometry...