Three-Year Outcomes Reveal 37% Mean IOP Decline
to 14.3 mmHg, 68% Decline in Mean Number of Topical Ocular
Hypotensive Medications and Favorable Safety Profile
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 a single-site international study of
glaucoma subjects recently published in Ophthalmology and Therapy
showed that the iStent inject® Trabecular Micro-Bypass System,
combined with cataract surgery, achieved a 37% reduction in mean
intraocular pressure (IOP) to 14.3 mmHg after three years of
follow-up.
The prospective, non-randomized, consecutive case series was
conducted by Fritz H. Hengerer, MD at the University of Heidelberg
in Heidelberg, Germany and included 81 eyes of 55 glaucoma subjects
undergoing cataract surgery. The cohort’s preoperative mean
medicated IOP was 22.6 mmHg and the preoperative mean number of
topical ocular hypotensive medications was 2.5. Approximately 32%
of eyes had undergone prior glaucoma surgery and 56% of eyes were
on at least three medications prior to iStent inject
implantation.
Additional study findings for subjects followed through three
years (n=41 eyes) included:
- Mean medication burden decreased 68% to
0.8.
- 93% of eyes experienced reduced
medications; 54% of eyes were medication free vs. 1%
preoperatively.
- All eyes achieved IOP at or below 18
mmHg and 71% achieved IOP at or below 15 mmHg.
- IOP was reduced by 20% or greater in
78% of eyes.
- The safety profile was favorable with
no intraoperative complications or significant side effects
reported.
“These study results are particularly noteworthy because they
were achieved across a clinically diverse patient population that
reflects a real-world practice,” said Dr. Hengerer, who performed
all of the procedures and authored the study. “The results show
that iStent inject in combination with cataract surgery is a
procedure capable of delivering substantial reductions in IOP and
medication burden not only in mild to moderate glaucoma cases, but
also in subjects who were previously using multiple topical
medications or had undergone prior glaucoma surgeries.”
The full published article is available here. Certain data from
this study were presented previously at ophthalmic conferences in
the United States and Europe.
Glaukos 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® Trabecular Micro-Bypass
Stent, in 2012 and approved its second-generation iStent inject
device 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 and South Africa.
“This study underscores the potential for iStent inject to be a
viable alternative to glaucoma patients’ chronic use of topical
medications, which often require complex dosing regimens, have
multiple side effects and can be ineffective due to high rates of
non-adherence,” said Thomas Burns, Glaukos president and chief
executive officer. “Our fundamental goal is to transform glaucoma
therapy by providing ophthalmic surgeons and their patients a
comprehensive set of MIGS technologies designed to safely and
effectively manage IOP across the full range of glaucoma
progression and severity.”
Glaukos is pursuing FDA approval for additional MIGS surgical
and sustained pharmaceutical therapy 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 U.S. with primary open-angle glaucoma, 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 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
safety and efficacy of our products, as might be suggested in the
published research referenced above, and the extent to which the
additional MIGS surgical and sustained pharmaceutical therapy
products we are developing receive applicable regulatory approval
or are commercialized in the United States or internationally.
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 Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018 filed
with the Securities and Exchange Commission. 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/20181211005188/en/
Glaukos CorporationMedia Contact:Cassandra Dump,
619-971-1887cassy@pascalecommunications.comorInvestor
Contact:Chris Lewis, Director, Investor Relations, Corporate
Development & Strategy949-481-0510clewis@glaukos.com
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Sep 2023 to Sep 2024