Ophthalmic pharmaceuticals and medical technology company Glaukos Corporation (NYSE:GKOS) announced on Wednesday that the US Food and Drug Administration (FDA) has approved a new drug application (NDA) labeling supplement allowing repeat administration of iDose TR (travoprost intracameral implant).

This approval reflects clinical evidence supporting the safety and tolerability of multiple administrations.

iDose TR is an intracameral, long-duration therapy that delivers continuous travoprost to the eye. It is intended to improve glaucoma treatment by addressing patient non-compliance and side effects associated with topical medications.

Physicians can now re-administer iDose TR in patients with a healthy cornea, as measured by corneal endothelial cell density. Clinical studies showed no clinically significant corneal endothelial cell loss over three years in Phase 2b and Phase 3 trials.

Results from the iDose TR exchange trial demonstrated that removal of the original implant and second administration was safe and well-tolerated, with a favorable safety profile over 12 months.