- Organizations: Sydnexis
Pipeline
FDA forms advisory committee to review Sydnexis's low-dose atropine
Federal agency to discuss phase 3 clinical data supporting SYD-101 for the treatment of pediatric progressive myopia following NDA rejection.
Pipeline
Sydnexis's low-dose atropine shows strong phase 3 efficacy for pediatric myopia
Recent 3-year data from the STAR trial meets primary and secondary endpoints for SYD-101, including the greatest treatment benefits among younger myopes.
Pipeline
Sydnexis reports phase 3 topline data on SYD-101 eye drop for pediatric myopia
The STAR study met both primary and secondary endpoints for low-dose atropine formulation—just days after the FDA’s NDA rejection.
Research
Viatris and Locus Biosciences to develop antibacterial therapies for ophthalmic infections
Collaboration will utilize Locus’ advanced precision drug development platform to address increasing burden of antimicrobial resistance in eye infections.
Pipeline
FDA rejects Sydnexis’ NDA for low-dose atropine drop
SYD-101 still has the potential to become the first pharmaceutical option for progressive myopia for patients aged 3 to 14.Pipeline
FDA accepts NDA for Sydnexis's low-dose atropine for pediatric myopia
Once-daily drop features unique establishing excipient to avoid rapid atropine degradation; may become first eye drop with 3-year shelf-life.
Business