Health Canada approves use of iStent inject
Health Canada has approved iStent inject to be used as standalone procedure or in conjunction with cataract surgery to reduce IOP, according to a Glaukos press release.
The approval is for reduction of IOP in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, the release said.
The results of two investigational and three postmarket studies were reviewed as part of the approval process. The studies included 346 patients who were implanted with iStent inject by 57 investigators in nine countries. In one study of iStent inject as a standalone treatment, 58 of 88 participants reached IOP of 18 mm Hg or less at 12 months – the primary endpoint; as a standalone treatment regardless of medication, 71 of 88 participants achieved that IOP – the secondary endpoint.
Ike K. Ahmed, MD, FRCSC, University of Toronto and Trillium Health Partners, said in the release, “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.”