Glaukos announces FDA approval of iDose TR NDA labeling supplement

Glaukos (GKOS) 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. 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. 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.