Glaukos submitted a new drug application to the FDA for the iDose TR, a microinvasive intraocular implant designed to continuously deliver a travoprost formulation for the treatment of glaucoma.
The submission is supported by positive data from two phase 3 pivotal trials that “achieved the prespecified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months,” according to a company press release.
The submission also includes positive data from an exchange trial that demonstrated successful safety results when an