Health Canada Approves Glaukos’ Glaucoma Stent System
Canadian regulators have approved California-based Glaukos’ iStent inject trabecular micro-bypass stent to reduce intraocular pressure in patients diagnosed with three types of glaucoma.
The system has an injector that delivers two preloaded stents through a single corneal entry point. The stents are about one-third the size of the company’s original iStent.
The stent can be used in combination with cataract surgery for patients who require IOP reduction or as a standalone procedure for patients who have elevated IOP despite prior treatment with glaucoma medications or conventional surgeries.
As part of the approval process, Health Canada reviewed the results of two investigational and three postmarket studies of 346 patients, which showed positive results using the stent as a standalone procedure and with medications.
The stent is approved in the EU and Australia, and Glaukos is seeking approval from the FDA to distribute it in the U.S. — John Bechtel