Business Wire07.23.19
Glaukos Corporation announced that results of an independent, international study showed standalone implantation of the iStent inject Trabecular Micro-Bypass System in eyes with substantial glaucoma disease burden achieved a 42 percent reduction in mean intraocular pressure (IOP) to 14.6 mmHg and an 82 percent reduction in mean medications to 0.55 at three years postoperative.
This prospective, consecutive case series of 44 eyes was conducted to evaluate the long-term outcomes of the two-stent iStent inject system as a sole procedure in predominantly primary open-angle glaucoma subjects with considerable disease burden. The cohort’s preoperative mean IOP was 25.3 mmHg on a mean of 2.98 ocular hypotensive medications, with 75 percent of eyes on three to five medications and no eyes medication-free. Moreover, 50 percent of eyes had a history of prior glaucoma surgery.
All iStent inject procedures were performed by Fritz H. Hengerer, M.D., Ph.D., at an academic ophthalmology center in Heidelberg, Germany. Additional results of eyes with three-year follow-up showed:
“The results of this study highlight the profound efficacy and safety profile of iStent inject as a sole procedure in a glaucoma patient population with substantial disease burden,” said Dr. Hengerer, the study’s author. “Of particular note is the very high portion of eyes— 97 percent—that achieved IOP at or below 18 mmHg at three years postoperative. This finding is key to our fundamental clinical goal of preserving glaucoma patients’ vision because reaching this IOP threshold is known to be associated with lessened visual field decline.”
Certain data from this study have been presented previously at professional ophthalmic meetings in the United States and Europe.
“While iStent inject has been studied primarily in patients with mild-to-moderate open-angle glaucoma, Dr. Hengerer’s results add to an emerging body of evidence suggesting that our multiple-stent technology may also be a viable option for patients with more advanced disease, including those who have undergone prior surgeries,” said Thomas Burns, Glaukos president and CEO. “Results like these further strengthen our resolve to advance our strategy to provide ophthalmic surgeons and their patients a comprehensive suite of injectable, micro-scale solutions capable of addressing a full range of glaucoma progression and disease states.”
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. In 2012, Glaukos received U.S. Food and Drug Administration (FDA) approval and launched its first MIGS device, the iStent Trabecular Micro-Bypass Stent.
The company’s second-generation MIGS device, the iStent inject Trabecular Micro-Bypass System, was approved by the FDA in June 2018. The iStent inject includes two stents preloaded in an auto-injection mechanism that allows an ophthalmic surgeon to inject stents into multiple locations of the trabecular meshwork through a single corneal incision. The iStent inject has also been approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa, and other international markets. Glaukos is also pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.
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 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 focused on the development and commercialization of 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.
This prospective, consecutive case series of 44 eyes was conducted to evaluate the long-term outcomes of the two-stent iStent inject system as a sole procedure in predominantly primary open-angle glaucoma subjects with considerable disease burden. The cohort’s preoperative mean IOP was 25.3 mmHg on a mean of 2.98 ocular hypotensive medications, with 75 percent of eyes on three to five medications and no eyes medication-free. Moreover, 50 percent of eyes had a history of prior glaucoma surgery.
All iStent inject procedures were performed by Fritz H. Hengerer, M.D., Ph.D., at an academic ophthalmology center in Heidelberg, Germany. Additional results of eyes with three-year follow-up showed:
- Mean IOP ≤ 18 mmHg was achieved by 97 percent of eyes vs. 9.1 percent preoperatively (p<0.0001), and mean IOP ≤ 15 mmHg was achieved by 70 percent of eyes vs. 2.3 percent preoperatively (p<0.0001).
- IOP decreased ≥ 20 percent vs. preoperative measurements in 88 percent of eyes.
- Sixty-one percent of eyes were medication free and all eyes maintained or decreased their three-year medication burden vs. preoperative levels.
- The safety profile was favorable, with minimal adverse events and stable corrected distance visual acuity reported.
“The results of this study highlight the profound efficacy and safety profile of iStent inject as a sole procedure in a glaucoma patient population with substantial disease burden,” said Dr. Hengerer, the study’s author. “Of particular note is the very high portion of eyes— 97 percent—that achieved IOP at or below 18 mmHg at three years postoperative. This finding is key to our fundamental clinical goal of preserving glaucoma patients’ vision because reaching this IOP threshold is known to be associated with lessened visual field decline.”
Certain data from this study have been presented previously at professional ophthalmic meetings in the United States and Europe.
“While iStent inject has been studied primarily in patients with mild-to-moderate open-angle glaucoma, Dr. Hengerer’s results add to an emerging body of evidence suggesting that our multiple-stent technology may also be a viable option for patients with more advanced disease, including those who have undergone prior surgeries,” said Thomas Burns, Glaukos president and CEO. “Results like these further strengthen our resolve to advance our strategy to provide ophthalmic surgeons and their patients a comprehensive suite of injectable, micro-scale solutions capable of addressing a full range of glaucoma progression and disease states.”
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. In 2012, Glaukos received U.S. Food and Drug Administration (FDA) approval and launched its first MIGS device, the iStent Trabecular Micro-Bypass Stent.
The company’s second-generation MIGS device, the iStent inject Trabecular Micro-Bypass System, was approved by the FDA in June 2018. The iStent inject includes two stents preloaded in an auto-injection mechanism that allows an ophthalmic surgeon to inject stents into multiple locations of the trabecular meshwork through a single corneal incision. The iStent inject has also been approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa, and other international markets. Glaukos is also pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.
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 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 focused on the development and commercialization of 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.