Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company, announced that it has received a "Day 74" notification from the US Food and Drug Administration (FDA) confirming that the previously submitted New Drug Application (NDA) for iDose TR (travoprost intraocular implant) is sufficiently complete to allow a substantive review. The FDA's goal date for completing its review of the iDose TR NDA under the Prescription Drug User Fee Act (PDUFA) is December 22, 2023. This date is consistent with management's expectations for the 505(b)(2) filing and reflects a standard 10-month review period.
"The acceptance of the iDose TR NDA represents another important step in bringing this potentially 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 we continue to believe iDose TR has the potential to be a transformative novel technology capable of fundamentally improving 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 favourable 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 favourable safety profile over a 12-month evaluation period.
The iDose TR intraocular implant is a micro-invasive intraocular implant designed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. iDose TR is intended to continuously deliver therapeutic levels of travoprost from within the eye for extended periods of time. It is designed to be removed and replaced with a new iDose TR, potentially providing a long-term dropless alternative to daily eye drop treatment.
The goal of iDose TR is to address common patient noncompliance and chronic side effects associated with topical IOP-lowering medications. Glaukos is an ophthalmic medical technology and pharmaceutical company specialising in the development and commercialization of novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
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