Glaukos submits new drug application for iDose TR
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.
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The submission also includes positive data from an exchange trial that demonstrated successful safety results when an original iDose TR was removed and replaced with a new one.
“The submission of the iDose TR NDA represents a significant milestone for our company, resulting from more than a decade of our teams’ unrelenting research, development and clinical efforts to bring this potential game-changing therapy one step closer to patients who may need a new glaucoma treatment alternative,” Thomas Burns, chairman and CEO of Glaukos, said in the release.