The company is enrolling patients for a pivotal IDE trial. Glaukos is developing a third-generation device, the iStent Supra, which drains into the suprachoroidal space.
Ivantis calls its Hydrus MicroStent the first “intracanalicular scaffold” for primary open-angle glaucoma. The 7-mm stent is inserted into Schlemm’s canal to increase outflow by dilating and stabilizing the canal structure.
The company has already treated over 1,800 patients in clinical trials or registry studies at more than 70 global sites. An IDE study, Hydrus 4, with more than 550 patients, should be completed by mid-year. A European study with Hydrus 2 showed a roughly 40% reduction in IOP using the same trial design as Hydrus 4.
“This device combines the advantages of conjunctiva sparring ab interno trabecular bypass with canal scaffolding and dilation,” said Brett Trauthen, chief scientific officer. “We saw a very robust IOP reduction that persisted through the second year.”
iSTAR Medical aims to augment the natural uveoscleral outflow using STARflo, a silicone device with 27-µm pores. The head of the device extends into the anterior chamber with the body curving through the sclera to the suprachoroidal space.