Glaukos Corporation has announced that the FDA has approved an NDA labeling supplement allowing for re-administration of iDose® TR using a repeat treatment protocol. The FDA approval is in response to Glaukos’ 2025 NDA labeling supplement application, and reflects accumulated clinical evidence supporting the safety and tolerability of repeat use for iDose TR.
iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
“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, Glaukos chairman and chief executive officer. “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 updated 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. In clinical studies, iDose TR has demonstrated a favorable long-term corneal safety profile, with no clinically significant corneal endothelial cell loss observed through three years across both the Phase 3 and Phase 2b studies. Additionally, results from the iDose TR exchange trial demonstrated a second administration of iDose TR and removal of the original iDose TR implant 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 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
“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, Glaukos chairman and chief executive officer. “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 updated 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. In clinical studies, iDose TR has demonstrated a favorable long-term corneal safety profile, with no clinically significant corneal endothelial cell loss observed through three years across both the Phase 3 and Phase 2b studies. Additionally, results from the iDose TR exchange trial demonstrated a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period.
