Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for iDose® TR (travoprost intraocular implant) is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review of the iDose TR NDA is set for December 22, 2023. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505(b)(2) filing.
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