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An FDA advisory committee convened on Oct. 30 to discuss SYD-101, a low-dose atropine eye drop that the FDA declined to approve last year for the slowing of pediatric myopia.
SYD-101 (atropine 0.01%, Sydnexis) met its primary endpoint in a phase 3 trial, but the FDA determined that the overall results suggested “limited to no clinical benefit.” Sydnexis submitted a formal dispute resolution request after receiving the FDA’s complete response letter in October 2025.
Representatives from Sydnexis gave an hour-long