■ Glaukos announced that it has submitted a New Drug Application (NDA) to the FDA for iDose TR, its microinvasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost within the eye for extended periods. The NDA includes data from 2 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. The application also includes data from the iDose TR exchange trial, which included removal of the original implant and administration of a second iDose TR, with the second administration demonstrating a favorable safety profile over 12 months.

“We look forward to working closely with the FDA in its 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,” Thomas Burns, Glaukos chairman and chief executive officer, said in a news release.