New International Study Highlights IOP-Lowering Performance Of Glaukos IStent Inject® Trabecular Micro-Bypass In Standalone Procedure

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that in a study published in Advances in Therapy, 100% of 57 phakic eyes with open-angle glaucoma achieved a = 20% reduction in unmedicated intraocular pressure (IOP) one year after implantation of the iStent inject ® Trabecular Micro-Bypass in a standalone procedure. Phakic refers to eyes that have not undergone prior cataract surgery and have a natural lens.

The iStent inject is a second-generation Micro-Invasive Glaucoma Surgery (MIGS) device that includes two stents preloaded into an auto-injection mechanism. It allows an ophthalmic surgeon to inject the stents from within the eye's anterior chamber through the trabecular meshwork and into Schlemm's canal, the eye's drainage canal. Once in place, the stents are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor.

The study was conducted at a single international site, where 11 surgeons performed the 57 iStent inject procedures. Study researchers reported a high safety profile and plan to follow subjects through five years. Additional study findings at one year postoperative included:
  • All eyes had IOP = 18 mm Hg and 67% of eyes had IOP = 15 mm Hg without medication vs. preoperative unmedicated IOP between 22-38 mm Hg.
  • Mean unmedicated IOP was 14.2 mm Hg, a 42% reduction from preoperative mean unmedicated IOP of 24.4 mm Hg; this reduction was maintained through 18 months.

"Our data suggest that second-generation trabecular stents, implanted as a sole procedure, can achieve sustained IOP and medication reductions in open-angle glaucoma patients," said Richard Lindstrom, MD, who authored the study. "These outcomes are promising because they underscore the potential for iStent inject to be a viable alternative to open-angle glaucoma patients' chronic use of topical ocular hypotensive medications, which often require complex dosing regimens, have multiple side effects and can be ineffective due to high rates of non-compliance."

The iStent inject uses the same fluidic mechanism of action as the first-generation iStent® Trabecular Micro-Bypass, which was approved by the U.S. Food & Drug Administration (FDA) in 2012 for use in conjunction with cataract surgery. 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. The iStent inject is approximately one-third the size of iStent and is for investigational use only in the United States, with two IDE clinical trials underway for two versions of the product, one for use in conjunction with cataract surgery and another for use as a standalone procedure.

In the European Union and Canada, iStent inject is approved for use either in combination with cataract surgery or as a standalone procedure. It is also approved for use in combination with cataract surgery in Australia.

The full Advances in Therapy article is available online at here.

Typically associated with elevated IOP, glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. It is a leading cause of blindness. 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.

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