Glaukos announces FDA acceptance of NDA submission for Epioxa

Glaukos

24 February 2025 - PDUFA date set for 20 October 2025.

Glaukos Corporation today announced it has received the “Day 74” notification from the US FDA acknowledging the previously submitted new drug application for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review.

Read Glaukos press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier