Glaukos Corporation 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.
“The acceptance of the iDose TR NDA represents another important step in bringing this potential game-changing therapy one step closer to patients who may need a new treatment alternative,” said Thomas Burns, Glaukos chairman and CEO. “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.”
The NDA submission includes data from two phase 3 pivotal trials of iDose TR, which both successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months.
In addition, the submission also includes data from the iDose TR exchange trial, which included a second administration of iDose TR and removal of the original iDose TR , with the second iDose TR administration demonstrating a favorable safety profile over a 12-month evaluation period.
iDose TR is a micro-invasive intraocular implant designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time.
It is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment.
iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical IOP-lowering medications.