Business Wire04.24.19
Glaukos Corporation announced that results of an international glaucoma study showed use of iStent Trabecular Micro-Bypass Stent during cataract surgerydelivered a 38 percent reduction in mean intraocular pressure (IOP) to 14.7 mmHg after five years of follow-up.
The prospective, non-randomized, consecutive case series was conducted at the Eye Clinic Marienplatz in Munich, Germany, by Medical Director Tobias H. Neuhann, M.D., and included 65 eyes of 43 patients with open-angle glaucoma or ocular hypertension. Thirty-eight percent of eyes had undergone prior trabeculectomy and/or glaucoma laser procedures and 68 percent were on at least two preoperative glaucoma medications.
Additional study findings for eyes followed through five years (n=26 eyes) included:
“The five-year outcomes for this study—which demonstrated appreciable reductions in IOP and medications along with an excellent safety profile—are among the longest of any published report on the use of trabecular micro-bypass stents in combination with cataract surgery,” said Dr. Neuhann, who performed all of the procedures and authored the study. “Importantly, the dataset evaluated outcomes in a varied patient population in terms of the type of glaucoma and the level of disease severity, and included many patients with significant preoperative medication burden and a history of prior glaucoma surgeries. This realistic scenario makes the outcomes particularly relevant for the typical ophthalmic practice, which must regularly evaluate treatment options for a wide range of glaucoma patients’ needs.”
Glaukos is the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The U.S. Food and 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 the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa, and other international markets.
“Dr. Neuhann’s five-year results further underscore the potent and sustained IOP-lowering capability of our iStent technology in real-world clinical situations,” said Thomas Burns, Glaukos president and CEO. “Moreover, these latest results add to the already formidable body of clinical evidence that helps ophthalmic surgeons appreciate the durability, predictability and reliability of using a single or multiple trabecular micro-bypass stents in combination with cataract surgery to effectively manage patients’ 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.
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.
Glaukos is an ophthalmic medical technology and pharmaceutical company developing and commercializing surgical devices and sustained pharmaceutical therapies designed to transform the treatment of 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 launched its next-generation iStent inject device in the United States in September 2018. Glaukos is leveraging its platform technology to build a proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent inject, measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
The prospective, non-randomized, consecutive case series was conducted at the Eye Clinic Marienplatz in Munich, Germany, by Medical Director Tobias H. Neuhann, M.D., and included 65 eyes of 43 patients with open-angle glaucoma or ocular hypertension. Thirty-eight percent of eyes had undergone prior trabeculectomy and/or glaucoma laser procedures and 68 percent were on at least two preoperative glaucoma medications.
Additional study findings for eyes followed through five years (n=26 eyes) included:
- A total of 92 percent of eyes had IOP ≤18 mmHg and 65 percent had IOP ≤15 mmHg.
- Mean medication use declined 75 percent to 0.5 topical ocular hypotensive medications, vs. 2.0 preoperatively.
- Approximately 69 percent of eyes were medication-free vs. 5 percent preoperatively.
- The safety profile was favorable throughout follow-up.
“The five-year outcomes for this study—which demonstrated appreciable reductions in IOP and medications along with an excellent safety profile—are among the longest of any published report on the use of trabecular micro-bypass stents in combination with cataract surgery,” said Dr. Neuhann, who performed all of the procedures and authored the study. “Importantly, the dataset evaluated outcomes in a varied patient population in terms of the type of glaucoma and the level of disease severity, and included many patients with significant preoperative medication burden and a history of prior glaucoma surgeries. This realistic scenario makes the outcomes particularly relevant for the typical ophthalmic practice, which must regularly evaluate treatment options for a wide range of glaucoma patients’ needs.”
Glaukos is the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The U.S. Food and 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 the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa, and other international markets.
“Dr. Neuhann’s five-year results further underscore the potent and sustained IOP-lowering capability of our iStent technology in real-world clinical situations,” said Thomas Burns, Glaukos president and CEO. “Moreover, these latest results add to the already formidable body of clinical evidence that helps ophthalmic surgeons appreciate the durability, predictability and reliability of using a single or multiple trabecular micro-bypass stents in combination with cataract surgery to effectively manage patients’ 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.
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.
Glaukos is an ophthalmic medical technology and pharmaceutical company developing and commercializing surgical devices and sustained pharmaceutical therapies designed to transform the treatment of 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 launched its next-generation iStent inject device in the United States in September 2018. Glaukos is leveraging its platform technology to build a proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent inject, measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
