Glaukos Corporation announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iDose TR.
iDose TR is a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.
“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,” said Thomas Burns, Glaukos chairman and CEO. “We look forward to working closely with the FDA in their pending review process and continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”
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.
Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure (IOP).
The iDose TR 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.