While both iStent and iStent inject showed significant IOP and medication reduction in combo-cataract procedures at 1 year postoperative, iStent inject achieved greater absolute IOP declines with 93% of subjects medication-free vs. 76% of iStent subjects
Image: Glaukos’ iStent inject delivers greater IOP reduction vs. iStent. Photo: Courtesy of Aline Berry/Pixabay
Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that an independent, international case series published in Ophthalmology and Therapy 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% of eyes in both groups were in early states of glaucoma disease progression and approximately 22% had prior glaucoma surgery. All procedures were performed by David Manning, MD, 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% of iStent inject eyes were medication-free at one-year postoperative, vs. 76.1% 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 U.S. 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 chief executive officer. “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.”
Source: Company Press Release