Glaukos Submits New Drug Application to FDA for iDose TR

Glaukos announced the submission of a new drug application (NDA) to the FDA for iDose TR. iDose TR is a micro-invasive intraocular implant that has been created to continuously provide therapeutic levels of a proprietary formulation of travoprost from inside the eye for prolonged durations. It is designed to combat the widespread problem of patient non-compliance and chronic side effects that are commonly linked 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,” Mr. Burns added.

The submission of the NDA for iDose TR to the FDA contains information from two phase 3 pivotal trials. Both trials met the primary efficacy endpoints within 3 months and showed a positive safety and tolerability profile within 12 months. The NDA also includes data from the iDose TR exchange trial, which involved a second administration of the implant and removal of the original iDose TR. This trial also demonstrated favorable safety results over a 12-month evaluation period.

The iDose TR is a medication containing a unique form of travoprost, a prostaglandin analog utilized for reducing intraocular pressure. It is administered via a micro-invasive procedure and can be taken out and replaced with a new iDose TR. This feature may provide a dropless alternative to daily eye drops, making it a potential long-term solution.