Sydnexis snubbed in pediatric myopia approval bid
Privately-held Californian biopharma Sydnexis has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of pediatric myopia in children.
Sydnexis has stressed that its NDA for SYD-101 was supported by the results of the Phase III STAR trial, the largest global clinical program completed to date in pediatric myopia, which evaluated more than 800 children aged three to 14 at treatment initiation.
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