Glaukos submits New Drug Application to FDA for micro-invasive intraocular implant

The NDA submission includes data from two Phase 3 pivotal trials of the implant. (Adobe Stock image)

Glaukos Corp. today announced the submission of its New Drug Application (NDA) to the FDA for its micro-invasive intraocular implant (iDose TR).

According to the company’s news release, the micro-invasive intraocular implant is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. The implant 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 CEO, said in the 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 the implant, 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.

According to the news release, administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. 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.