■ Glaukos has received the “Day 74” notice from FDA regarding its iDose TR (travoprost intraocular implant) new drug application (NDA). The PDUFA goal date is set for December 22, 2023.

The iDose TR is a microinvasive intraocular implant that continuously delivers therapeutic levels of a proprietary formulation of travoprost for extended periods and can be removed and replaced with a new implant. This potentially dropless solution is a way to address patient noncompliance and chronic side effects associated with topical IOP-lowering medications.

The NDA is based on data from 2 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. The submission also includes data from the iDose TR exchange trial, which evaluated removal and replacement of a second iDose TR showing a favorable safety profile over 12 months.

“We look forward to working closely with the FDA throughout their review process and continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension,” said chairman and CEO Thomas Burns in a news release.