Glaukos announced that implantation of one, two, or three iStent Trabecular Micro-Bypass Stents achieved mean unmedicated IOP reductions of 30%, 37%, and 43%, respectively, at 36 months postoperative. The results of the study were published in Clinical Ophthalmology.
In this prospective, randomized study conducted by multiple surgeons at a single investigational site, 119 open-angle glaucoma (OAG) subjects with preoperative unmedicated IOP of 22 mmHg to 38 mmHg received one, two or three iStents in a standalone procedure. At approximately 36 months postoperative, the one-, two- and three-stent groups achieved unmedicated (post-washout) mean IOP of 17.4 mmHg, 15.8 mmHg, and 14.2 mmHg, respectively, compared to preoperative unmedicated mean IOP of 25.0 mmHg for the one- and two-stent groups and 25.1 mmHg for the three-stent group. At 42 months, 61%, 91% and 91% of eyes in the one-, two- and three-stent groups, respectively, achieved a ≥20% reduction in IOP without medication.
“The latest results of this ongoing study further underscore the durable and substantial IOP-lowering and medication-reducing effects of one or multiple iStents in mild-to-moderate glaucoma patients,” L. Jay Katz, MD FACS, who co-authored the study, said in a company news release. Dr. Katz is the director of Glaucoma Service at the Wills Eye Hospital and is Glaukos chief medical officer. “Moreover, the study’s findings corroborate the data of prior laboratory investigations and clinical studies, making clear that the most significant portion of the IOP reduction results from implantation of the first stent, with each additional stent providing additional incremental benefits.”
According to the study authors, no intraoperative or perioperative complications were reported. During 42 months of postoperative follow-up, the most commonly reported adverse event was progression of pre-existing cataract. However, no eyes required additional glaucoma surgery.
The full article is available here. Outcomes in this study through 18 months were published in 2015 by Clinical Ophthalmology. Study subjects will continue to be followed for a total of 60 months.
“At Glaukos, we have long believed in the potential to titrate MIGS technologies in order to effectively manage glaucoma patients’ IOP based on their specific clinical needs,” said Thomas Burns, Glaukos president and chief executive officer. “While the indication for our current iStent device is for implantation of a single stent in mild-to-moderate glaucoma patients undergoing cataract surgery, these latest study results help to illustrate the value of ultimately providing surgeons a comprehensive array of single- and multi-stent MIGS devices designed to address a full range of glaucoma disease states and progression.”
- iStent inject Trabecular Micro-Bypass System, which is designed for use during cataract surgery and allows a surgeon to inject stents into two trabecular meshwork locations through a single corneal entry point. The iStent inject is approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South America.
- iStent SA Trabecular Micro-Bypass System, which is a standalone, two-stent procedure that is similar to the iStent inject and designed to reduce IOP in pseudophakic, mild-to-moderate OAG eyes.
- iStent infinite Trabecular Micro-Bypass System, which is a standalone, three-stent procedure, designed to reduce IOP in refractory OAG patients.
- iStent Supra Suprachoroidal Micro-Bypass Stent, which is designed to reduce IOP by accessing the eye’s suprachoroidal space and is approved in the European Union.
- iDose Travoprost, which is an implant containing a special formulation of travoprost, a prostaglandin analog used to reduce IOP. Implanted during a micro-invasive procedure, the iDose Travoprost is designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time. When depleted, it can be removed and replaced in a similar, subsequent procedure.