Prospective, Randomized Trial Highlights 5-Year Performance of 2 Standalone Glaukos iStents vs. Topical Prostaglandin in Newly Diagnosed Glaucoma Patients - Seite 2

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Thomas Burns, Glaukos president and chief executive officer. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Glaukos, the study sponsor, 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 conjunction with cataract surgery or as a standalone procedure in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets.

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 POAG, the most common form of the disease.

About iStent inject Trabecular Micro-Bypass System (U.S.)

Indication for Use: The iStent inject Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma.

Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.