Glaukos announced that the FDA has approved a new drug application (NDA) labeling supplement for iDose TR that allows for re-administration using a repeat treatment protocol.

The FDA approval follows Glaukos’ 2025 NDA labeling supplement submission and is supported by accumulated clinical evidence demonstrating the safety and tolerability of repeat use of iDose TR. According to Glaukos, the updated labeling provides physicians with additional flexibility to manage patients over time and expands access for patients who may benefit from repeat treatment.

“We are pleased to announce this important labeling enhancement for iDose TR, which should help expand access for patients who may benefit from repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time,” said Thomas Burns, chairman and CEO of Glaukos. “This approval further validates iDose TR’s established and proven safety profile and reinforces its leading position in addressing the strong and growing demand within the ophthalmic community for safe, effective, and sustained procedural pharmaceutical alternatives to traditional topical medications.”

Under the revised labeling, physicians may now re-administer iDose TR more than once in patients who maintain a healthy cornea, as defined by corneal endothelial cell density parameters. Across phase 3 and phase 2b clinical studies, iDose TR demonstrated a favorable long-term corneal safety profile, with no clinically significant corneal endothelial cell loss observed through 3 years of follow-up.

Additional support for repeat treatment comes from the iDose TR exchange trial, which evaluated the removal of the original iDose TR implant followed by administration of a second implant. Results showed that the procedure was safe and well tolerated, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period.

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost directly inside the eye, 24 hours a day, for extended periods. The therapy is intended to improve the standard of care in glaucoma by addressing common challenges associated with topical eye drops, including patient non-compliance and chronic side effects.

For more information about iDose TR, including Full Prescribing Information, visit www.iDoseTRhcp.com.