US FDA Accepts Glaukos’ NDA for iDose TR Implant for Glaucoma

Glaukos announced May 5 that the US FDA had accepted the new drug application (NDA) for its iDose TR (travoprost intraocular implant) in glaucoma and set a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 22.

iDose TR is implanted in the anterior chamber, anchored to the sclera just behind the trabecular meshwork. It is designed to release travoprost for at least a year, and can be removed and replaced, offering an alternative to daily eye drop treatment for glaucoma, Glaukos says.

The submission includes positive results from a trial designed to evaluate the safety of a surgical exchange procedure for the iDose TR.

Glaukos, of Aliso Viejo, California, said the exchange procedure was safe and well-tolerated, and no subject in the exchange trial suffered greater than a 30 percent endothelial cell loss over the extended evaluation period of more than five years, on average.