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# FDA Reviewing Glaukos NDA for Glaucoma
- URL: https://www.fdaweb.com/fda-reviewing-glaukos-nda-for-glaucoma/
- Published: 2023-05-05T12:00:00.000Z
- Updated: 2026-09-14T18:29:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154386

FDA has accepted for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension. The agency has set a 12/22 user fee review action target date of 12/22.

The submission is based on data from two Phase 3 pivotal trials which the company says met pre-specified primary efficacy endpoints through three months and demonstrated a favorable tolerability and safety profile through 12 months. The implant is designed to “continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time,” Glaukos says.