iStent Cohort Achieved Significantly Higher Treatment Success And
Significantly Fewer iStent Subjects Required Add-on Medications at 5
Years Postoperative, Compared to Topical Prostaglandin Subjects
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and
pharmaceutical company focused on the development and commercialization
of novel surgical devices and sustained pharmaceutical therapies
designed to transform the treatment of glaucoma, announced today that
results of an international glaucoma study published in Ophthalmology
Glaucoma showed standalone implantation of two iStent®
Trabecular Micro-Bypass Stents in newly diagnosed primary open-angle
glaucoma (POAG) eyes achieved a 35.3% reduction in mean
intraocular pressure (IOP) to 16.5 mmHg after five years of follow-up.
The purpose of this prospective, randomized, controlled, multi-surgeon
clinical trial was to evaluate the five-year safety and efficacy of two iStents
vs. topical prostaglandin as an initial intervention in POAG
subjects who had not had prior glaucoma treatment of any kind. A total
of 101 subjects were randomized in a 1:1 ratio to receive either two iStents
in a standalone procedure or once-daily topical travoprost, a commonly
prescribed prostaglandin. At five years, results showed:
-
- Mean diurnal IOP was 16.5 mmHg (35.3% reduction; p < 0.0001) for the
stent group vs. 16.3 mmHg (35.1% reduction) for the travoprost group,
excluding eyes in both cohorts that underwent cataract surgery during
follow-up.
- Mean diurnal IOP was 16.5 mmHg (35.3% reduction; p < 0.0001) for the
-
- Treatment success – defined as mean diurnal IOP of 6 mmHg to 18 mmHg
without add-on medication or secondary glaucoma surgery – was achieved
in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04).
- Treatment success – defined as mean diurnal IOP of 6 mmHg to 18 mmHg
-
- Seventeen percent of stent eyes vs. 44% of travoprost eyes required
add-on medication.
- Seventeen percent of stent eyes vs. 44% of travoprost eyes required
-
- The need for add-on medication arose at a slower rate in the stent
group than in the travoprost group, especially after two years of
follow-up. Study authors observed that from two to five years of
follow-up, add-on medications were initiated in roughly double the
number of travoprost eyes vs. stent eyes.
- The need for add-on medication arose at a slower rate in the stent
-
- The safety profile was excellent in both groups throughout follow-up.
“These results illustrate the enduring efficacy and safety of using
multiple trabecular bypass stents in a standalone procedure as initial
intervention to manage IOP in newly diagnosed, treatment-naïve glaucoma
patients,” said Robert D. Fechtner, MD, an ophthalmic surgeon based in
Syracuse, NY and lead author of the Ophthalmology Glaucoma
article. “Topical ocular hypotensive medications are typical first-line
glaucoma therapy but these drugs can be ineffective due to high rates of
patient non-adherence, ocular surface damage, cost and other factors.
This study shows that not only are Glaukos’ iStents as effective
as once-daily topical travoprost in controlling IOP, but they also
succeed at maintaining IOP reductions over the long-term with fewer
additional medications.”
Three-year outcomes of this study were published in 2016 in Ophthalmology
and Therapy. The most recent article detailing five-year outcomes
may be accessed online here.
“This latest publication represents the first-ever five-year,
protocol-driven, randomized evaluation of standalone iStent implantation
in newly diagnosed glaucoma patients,” said Thomas Burns, Glaukos
president and chief executive officer. “Moreover, it adds meaningful
outcomes data to the growing body of peer-reviewed evidence that
implantation of a single or multiple iStents can reliably achieve
sustained IOP reductions in an elegant, tissue-sparing procedure with a
highly favorable safety profile.”
Glaukos, the study sponsor, is the pioneer of Micro-Invasive Glaucoma
Surgery, or MIGS. The U.S. Food & 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 conjunction with cataract surgery or as a standalone
procedure in the European Union, Armenia, Australia, Brazil, Canada,
Hong Kong, Singapore, South Africa and other international markets.
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 POAG, the
most common form of the disease.
About iStent inject Trabecular Micro-Bypass System (U.S.)
Indication for Use: 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.
Contraindications: The iStent inject is contraindicated in eyes
with angle-closure glaucoma, traumatic, malignant, uveitic, or
neovascular glaucoma, discernible congenital anomalies of the anterior
chamber angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber
Syndrome or any other type of condition that may cause elevated
episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude
congenital anomalies of the angle, PAS, rubeosis, or conditions that
would prohibit adequate visualization of the angle that could lead to
improper placement of the stent and pose a hazard.
MRI Information: The iStent inject is MR-Conditional, i.e., the
device is safe for use in a specified MR environment under specified
conditions; please see Directions for Use (DFU) label for details.
Precautions: The surgeon should monitor the patient postoperatively for
proper maintenance of IOP. The safety and effectiveness of the iStent
inject have not been established as an alternative to the primary
treatment of glaucoma with medications, in children, in eyes with
significant prior trauma, abnormal anterior segment, chronic
inflammation, prior glaucoma surgery (except SLT performed > 90 days
preoperative), glaucoma associated with vascular disorders,
pseudoexfoliative, pigmentary or other secondary open-angle glaucomas,
pseudophakic eyes, phakic eyes without concomitant cataract surgery or
with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or
unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or
less than two stents.
Adverse Events: Common postoperative adverse events reported in the
randomized pivotal trial included stent obstruction (6.2%), intraocular
inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery
only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2
lines ≥ 3 months (2.6% vs. 4.2%).
Caution: Federal law restricts this device to sale by, or on the order
of, a physician. Please see DFU for a complete list of
contraindications, warnings, precautions, and adverse events.
For more information, visit www.glaukos.com.
About iStent Trabecular Micro-Bypass Stent (U.S.)
Indication for Use: 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.
Contraindications: 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.
Warnings: Gonioscopy should be performed prior to surgery to exclude
PAS, rubeosis, and other angle abnormalities or conditions that would
prohibit adequate visualization of the angle that could lead to improper
placement of the stent and pose a hazard. The iStent is
MR-Conditional meaning that the device is safe for use in a specified MR
environment under specified conditions, please see label for details.
Precautions: The surgeon should monitor the patient postoperatively for
proper maintenance of intraocular pressure. The safety and effectiveness
of the iStent has not been established as an alternative to the
primary treatment of glaucoma with medications, in children, in eyes
with significant prior trauma, chronic inflammation, or an abnormal
anterior segment, in pseudophakic patients with glaucoma, in patients
with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in
patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg
after “washout” of medications, or in patients with prior glaucoma
surgery of any type including argon laser trabeculoplasty, for
implantation of more than a single stent, after complications during
cataract surgery, and when implantation has been without concomitant
cataract surgery with IOL implantation for visually significant cataract.
Adverse Events: The most common post-operative adverse events reported
in the randomized pivotal trial included early post-operative corneal
edema (8%), BCVA loss of ≥ 1 line at or after the 3 month visit (7%),
posterior capsular opacification (6%), stent obstruction (4%) early
post-operative anterior chamber cells (3%), and early post-operative
corneal abrasion (3%). Please refer to Directions for Use for additional
adverse event information.
Caution: Federal law restricts this device to sale by, or on the order
of, a physician. Please reference the Directions for Use labeling for a
complete list of contraindications, warnings, precautions, and adverse
events.