Study Evaluates a Single Glaukos iStent Trabecular Micro-Bypass Stent as a Standalone Procedure

Glaukos Corporation, an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, announced that a study published recently in the Journal of Glaucoma showed that a single iStent Trabecular Micro-Bypass Stent significantly reduced intraocular pressure (IOP) when implanted as a standalone procedure in pseudophakic eyes with open-angle glaucoma. Pseudophakic refers to eyes in which the natural lens has previously been removed and replaced with an intraocular lens.
 
In this retrospective, consecutive case series, researchers from the University of South Dakota Sanford School of Medicine and Sioux Falls-based Vance Thomson Vision evaluated iStent procedure outcomes in 42 pseudophakic eyes with preoperative mean IOP of 20.26 mm Hg. In 21 eyes followed for two years, mean medicated IOP decreased 6.64 mm Hg to 13.62 mm Hg, or 33 percent.
 
In total, 96 percent of study patients with pre-operative medicated IOP ≥ 19 mm Hg achieved an IOP reduction at their last collected follow-up. With a low rate of postoperative IOP spikes and only one patient requiring additional glaucoma surgery, the safety profile was favorable. In order to mimic the device’s actual clinical use, study researchers enrolled patients with primary open-angle glaucoma, normal tension glaucoma and ocular hypertension, with no other exclusion criteria.
 
“While multiple studies and years of real-world experience have demonstrated the ability of iStent to achieve sustained IOP reductions when used in combination with cataract surgery, we wanted to explore the IOP-lowering performance of iStent as a sole procedure in pseudophakic eyes,” said John P. Berdahl, M.D., who performed all of the procedures evaluated in the study. “In this series of iStent procedures occurring between October 2012 and May 2015, we recorded IOP reductions at one and two years postoperatively that were both clinically and statistically significant.”
 
Dr. Berdahl added, “These types of results are important to glaucoma surgeons and patients because landmark studies such as the Early Manifest Glaucoma Trial have shown that every 1 mm Hg improvement in IOP can reduce the likelihood of disease progression.”
 
The iStent was approved by the U.S. Food & Drug Administration (FDA) in June 2012 and is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. Made of surgical-grade non-ferromagnetic titanium that is coated with heparin, the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos believes it is the smallest medical device ever approved by the FDA.
 
Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing IOP is the only proven treatment. According to Market Scope, more than 80 million people worldwide have glaucoma, including 4.5 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.6 million people in the United States.
 
The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8 percent), BCVA loss of ≥ 1 line at or after the three-month visit (7 percent), posterior capsular opacification (6 percent), stent obstruction (4 percent) early post-operative anterior chamber cells (3 percent), and early post-operative corneal abrasion (3 percent).
 
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of products and procedures to treat glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.