The FDA intends to hold an advisory committee meeting on SYD-101, which is being investigated for pediatric myopia but was not approved despite achieving endpoints in a phase 3 trial, according to a press release from Sydnexis.
The announcement follows a formal dispute resolution request that Sydnexis sent the FDA after the agency issued its complete response letter opting not to approve SYD-101 in October 2025.
SYD-101 is an investigational formulation of low-dose atropine 0.01%. Compounded atropine for pediatric progressive myopia management depends on access to compounding pharmacies and is