Glaukos, an ophthalmic medical technology and pharmaceutical company, announced that results of an international glaucoma study published in the Journal of Cataract and Refractive Surgery showed use of iStent Trabecular Micro-Bypass Stent during cataract surgery delivered a 38% reduction in mean intraocular pressure (IOP) to 14.7 mmHg after five years of follow-up.
Image: International glaucoma study has confirmed long-term efficacy and safety profile of Glaukos iStent implantation in combination with cataract surgery. Photo: courtesy of one pluse one / FreeDigitalPhotos.net.
The prospective, non-randomized, consecutive case series was conducted at the Eye Clinic Marienplatz in Munich, Germany by Medical Director Tobias H. Neuhann, MD and included 65 eyes of 43 patients with open-angle glaucoma or ocular hypertension.
Thirty-eight percent of eyes had undergone prior trabeculectomy and/or glaucoma laser procedures and 68% were on at least two preoperative glaucoma medications.
Additional study findings for eyes followed through five years (n=26 eyes) included:
A total of 92% of eyes had IOP ≤18 mmHg and 65% had IOP ≤15 mmHg.
Mean medication use declined 75% to 0.5 topical ocular hypotensive medications, vs. 2.0 preoperatively.
Approximately 69% of eyes were medication-free vs. 5% preoperatively.
The safety profile was favorable throughout follow-up.
These results were presented in part at the 2016 annual meeting of the European Society of Cataract and Refractive Surgeons and three-year outcomes of this study were published in the Journal of Cataract and Refractive Surgery in 2015.
“The five-year outcomes for this study – which demonstrated appreciable reductions in IOP and medications along with an excellent safety profile – are among the longest of any published report on the use of trabecular micro-bypass stents in combination with cataract surgery,” said Dr. Neuhann, who performed all of the procedures and authored the study.
“Importantly, the dataset evaluated outcomes in a varied patient population in terms of the type of glaucoma and the level of disease severity, and included many patients with significant preoperative medication burden and a history of prior glaucoma surgeries. This realistic scenario makes the outcomes particularly relevant for the typical ophthalmic practice, which must regularly evaluate treatment options for a wide range of glaucoma patients’ needs.”
Glaukos is the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The U.S. Food & Drug Administration (FDA) approved the company’s first MIGS device, the iStent, in 2012 and approved its second-generation iStent inject Trabecular Micro-Bypass System in 2018.
Inserted through a small corneal incision made during cataract surgery, the iStent is designed to reduce IOP by restoring the natural physiological outflow of aqueous humor.
The iStent inject relies on the same fluidic method of action but is designed to deploy two stents into separate trabecular meshwork locations through a single corneal entry point for enhanced IOP reduction and procedural ease. The iStent inject is also approved for use in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets.
“Dr. Neuhann’s five-year results further underscore the potent and sustained IOP-lowering capability of our iStent technology in real-world clinical situations,” said Thomas Burns, Glaukos president and chief executive officer.
“Moreover, these latest results add to the already formidable body of clinical evidence that helps ophthalmic surgeons appreciate the durability, predictability and reliability of using a single or multiple trabecular micro-bypass stents in combination with cataract surgery to effectively manage patients’ IOP.”
Glaucoma is characterized by progressive, irreversible vision loss caused by optic nerve damage. There is no cure for the disease. However, by reducing the eye pressure, the only proven effective treatment, vision may be stabilized. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. with primary open-angle glaucoma, the most common form of the disease.
Source: Company Press Release