The newly cleared iStent inject is indicated for micro-invasive glaucoma surgery procedures to reduce intraocular pressure in patients with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, the Laguna Hills, Calif-based company said.
“The Health Canada approval of the iStent inject is another important advancement in the MIGS category. MIGS devices, used early in the glaucoma treatment algorithm, can provide an effective alternative to additional topical medications that can create adherence challenges, side effects and quality-of-life issues. The availability of iStent inject with expanded indications for use as a standalone procedure or in conjunction with cataract surgery means more patients can now benefit from this exciting new class of glaucoma interventions,” Dr. Ike Ahmed of the University of Toronto said in a press release.
Glaukos’ iStent Inject, made from non-ferromagnetic titanium and coated in heparin, is designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP, the company said.
“We are committed to remaining at the forefront of glaucoma innovation and are building a comprehensive portfolio of micro-scale injectable therapies that can serve the full spectrum of surgeon and patient needs. This approval marks an important step forward in our strategy to extend the reach of our iStent technology platform in key regions around the world,” CEO Thomas Burns said in a press release.
Last month, Glaukos won approval from the Australian Therapeutic Goods Administration for the iStent inject for adult patients with mild-to-moderate glaucoma who are currently being treated with ocular hypotensive medication.