FDA allows re-administration of iDose® TR
The US Food and Drug Administration (FDA) approved a new drug application labeling supplement that allows for the re-administration of iDose® TR (travoprost intracameral implant) using a repeat treatment protocol.
Clinicians can now re-administer iDose TR more than once in patients who have a healthy cornea, as defined by corneal endothelial cell density paramethers.
Results from the iDose TR exchange trial showed that a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated. The second iDose TR implant maintained a “favorable” safety profile over 12-months of follow-up.
iDose TR is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Source: Press release
