Glaukos Submits NDA to FDA for iDose TR

Glaukos announced the submission of a new drug application (NDA) to the FDA for iDose TR, 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,” Thomas Burns, Glaukos chairman and chief executive officer, said in a company news release. “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 prespecified 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 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.