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
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.
- 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).
- Seventeen percent of stent eyes vs. 44%
of travoprost eyes required add-on medication.
- 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 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.
About Glaukos
Glaukos (www.glaukos.com) is 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, 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
comprehensive and 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.
Forward-Looking Statements
All statements other than statements of historical facts
included in this press release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements. Although we
believe that we have a reasonable basis for forward-looking
statements contained herein, we caution you that they are based on
current expectations about future events affecting us and are
subject to risks, uncertainties and factors relating to our
operations and business environment, all of which are difficult to
predict and many of which are beyond our control, that may cause
our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties include, without limitation, the
continued efficacy and safety profile of our products as might be
suggested in the published research referenced above. These risks,
uncertainties and factors are described in detail under the caption
“Risk Factors” and elsewhere in our filings with the Securities and
Exchange Commission, including our Annual Report on Form 10-K for
the fiscal year ended December 31, 2018. Our filings with the
Securities and Exchange Commission are available in the Investor
Section of our website at www.glaukos.com or at www.sec.gov. In
addition, information about the risks and benefits of our products
is available on our website at www.glaukos.com. All forward-looking
statements included in this press release are expressly qualified
in their entirety by the foregoing cautionary statements. You are
cautioned not to place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190415005186/en/
Media:Cassandra
Dump619-971-1887cassy@pascalecommunications.comInvestor:Chris
Lewis, Director, Investor Relations, Corporate Development &
Strategy949-481-0510clewis@glaukos.com
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Apr 2023 to Apr 2024