Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia

Sydnexis

11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and has assigned a PDUFA target action date of 23 October 2025. 

If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of paediatric myopia in the US.

Read Sydnexis press release

Michael Wonder

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Michael Wonder