In October 2025, the FDA issued a complete response letter to Sydnexis regarding SYD-101, an investigational formulation of low-dose atropine 0.01%. Despite achieving its primary phase 3 efficacy endpoint, the eye drop was not approved.
More recently, the FDA announced that it will hold an advisory committee meeting Oct. 30 to address SYD-101, renewing the eye care community’s hope for an on-label low-dose formulation of atropine.
In a round table discussion, Healio | OSN Pediatrics/Strabismus Board Members M. Edward Wilson, MD, and Douglas R. Fredrick, MD, discussed the FDA’s shortcomings in