Data Show Glaukos’ iStent inject Delivers Greater IOP Reduction vs. iStent

Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced that an independent, a recently published international case series showed that iStent inject Trabecular Micro-Bypass System achieved a greater absolute intraocular pressure (IOP) reduction and a higher medication-free rate at one year postoperative, compared to the first-generation iStent Trabecular Micro-Bypass Stent. All subjects in the case series received stents in combination with cataract surgery.
 
This real-world retrospective case series included 137 eyes with cataract and mild-to-moderate glaucoma or ocular hypertension. More than 73 percent of eyes in both groups were in early states of glaucoma disease progression and approximately 22 percent had prior glaucoma surgery. All procedures were performed by David Manning, M.D., at a single practice in Australia. Consecutive patients received either iStent inject (n=70) or iStent (n=67), based on availability in the Australian market.
 
At one year postoperative, mean IOP in eyes receiving iStent inject decreased 1.8 mmHg more than iStent eyes, based on the decrease in absolute IOP for each group. In addition, 92.9 percent of iStent inject eyes were medication-free at one-year postoperative, vs. 76.1 percent for the iStent eyes. The safety profile was favorable in both groups, with few adverse events and no secondary glaucoma surgeries.
 
“This case series represents one of the first and largest datasets to compare performance of iStent and iStent inject in the hands of a single surgeon and underscores the ability of both devices to effectively reduce IOP and medication burden in a procedure with an excellent safety profile,” said Dr. Manning, a glaucoma surgeon at the Hunter Cataract and Eye Centre in Charleston, South Australia. “Even though the study was not designed for prospective comparison, it highlights the added benefit and peace of mind iStent inject can offer surgeons and patients in terms of reliably managing 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 United States with primary open-angle glaucoma, the most common form of the disease.
 
Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS), which involves insertion of a micro-scale device from within the eye’s anterior chamber through a small corneal incision. Glaukos’ MIGS devices are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. The trabecular meshwork is the site of greatest resistance to outflow in glaucomatous eyes. Glaukos received U.S. Food and Drug Administration (FDA) approval for its first-generation MIGS device, the iStent, in 2012. Its second-generation iStent inject, which received FDA approval in 2018, includes two stents preloaded in an auto-injection mechanism that facilitates stent insertion into multiple trabecular meshwork locations through a single corneal incision. The iStent inject is also approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets. Glaukos is pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.
 
“Dr. Manning’s real-world experience makes clear that iStent and iStent inject both succeed in lowering IOP, with the iStent inject offering some meaningful advantages,” said Thomas Burns, Glaukos president and CEO. “The iStent inject provides surgeons enhanced procedural ease and facilitates creation of two distinct, multi-directional outflow pathways, designed to reduce IOP and the need for topical glaucoma medications, which have troubling side effects and persistently high non-adherence rates. The elegance and predictability of iStent inject represents yet another Glaukos innovation designed to tackle important unmet clinical needs with novel surgical or sustained pharmaceutical solutions for people suffering with glaucoma, corneal disorders and retinal diseases.”
 
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.
 
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 iStent is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
 
Glaukos is an ophthalmic medical technology and pharmaceutical company focused on therapies for the treatment of glaucoma, corneal disorders and retinal diseases. 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 launched its next-generation iStent inject device in the United States in September 2018. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.