86% of Eyes Had IOP ≤ 18 mm Hg at Three Years
Postoperative, According to Results Published in Clinical
Ophthalmology
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical
technology company focused on the development and commercialization
of breakthrough products and procedures designed to transform the
treatment of glaucoma, today announced that a study published in
Clinical Ophthalmology showed that two iStent® Trabecular
Micro-Bypass Stents and one topical ocular hypotensive medication
achieved a 38% reduction in mean medicated intraocular pressure
(IOP) three years following surgery in 37 phakic eyes. Phakic
refers to eyes that have not undergone prior cataract surgery and
still have a natural lens.
This prospective study, conducted at a single international
site, enrolled patients with open-angle glaucoma (OAG) not
controlled on two topical medications and with unmedicated IOP of
22-38 mm Hg. All patients in the study received two iStents in a
standalone procedure, and began daily use of topical travoprost one
day after surgery. Through three years, 86% of eyes achieved IOP ≤
18 mm Hg. Mean medicated IOP in these eyes decreased to 14.0 mm Hg
on one medication, versus 22.4 mm Hg on two medications
preoperatively. The safety profile was favorable with no
intraoperative or device-related adverse events reported.
These three-year results update 18-month data from the same
study that was published in 2014 in the Journal of Cataract and
Refractive Surgery. In that publication, follow-up through 18
months showed a decrease in medicated IOP to 14 mm Hg or less on
one medication, versus 22.2 mm Hg on two medications
preoperatively. Study researchers plan to continue to follow
patients through five years postoperative.
“The three-year data demonstrate the long-term performance and
safety of trabecular bypass stents and topical travoprost in
subjects with OAG not controlled on two medications,” said David F.
Chang, MD, who authored the Clinical Ophthalmology article. “In
addition, our results support the hypothetical synergy of using
trabecular stents to increase outflow through the conventional
aqueous fluid pathway while also using a prostaglandin analog such
as topical travoprost to increase outflow through the uveoscleral,
or unconventional, pathway.”
Glaukos is the study sponsor and the pioneer of Micro-Invasive
Glaucoma Surgery, or MIGS. The iStent was approved by the U.S. Food
& Drug Administration in 2012 and is the industry’s flagship
MIGS device. Inserted through the trabecular meshwork and into
Schlemm’s canal via a small corneal incision made during cataract
surgery, the iStent is designed to restore the natural,
physiological outflow of aqueous fluid through the conventional
pathway and reduce IOP. The company also is pursuing FDA approval
of two versions of its next-generation iStent inject® Trabecular
Micro-Bypass device: one for use in combination with cataract
surgery and another for use in a standalone procedure. The iStent
inject is designed to deploy two stents into separate trabecular
meshwork locations and is being evaluated in FDA clinical trials
for IOP reduction. The company also is pursuing FDA approval of a
third MIGS device, the iStent SUPRA, which accesses the uveoscleral
pathway for aqueous humor outflow.
“Our fundamental goal is to transform glaucoma therapy by
providing ophthalmic surgeons and their patients a full complement
of micro-scale glaucoma technologies that deliver sustained
reductions in IOP and topical medication use,” said Thomas Burns,
Glaukos president and chief executive officer. “Study results like
these help to strengthen our view that future glaucoma therapy may
ultimately involve use of multiple stents and multiple pathways for
aqueous fluid outflow to manage patients’ IOP and disease
progression.”
Glaucoma is characterized by progressive, irreversible and
largely asymptomatic vision loss caused by optic nerve damage.
There is no cure for the disease and reducing IOP is the only
proven treatment. According to Market Scope, more than 80 million
people worldwide have glaucoma, including 4.5 million people in the
United States. Open-angle glaucoma is the most common form,
affecting approximately 3.6 million people in the United
States.
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
company focused on the development and commercialization of
breakthrough products and procedures 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, measuring 1.0 mm long and 0.33 mm
wide, 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 limitations, the
continued efficacy of our products as might be suggested in the
study described herein; the extent to which the company will be
able to obtain regulatory approval for its next-generation
products; and the extent to which the company’s next-generation
products will obtain an indication of use for multiple stents and
multiple pathways for aqueous fluid outflow. 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 year ended December 31, 2016 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170413005281/en/
Glaukos CorporationMedia Contact:Cassandra Dump(619)
971-1887cassy@pascalecommunications.comorInvestor
Contact:Sheree AronsonVP, Investor Relations(949) 367-9600 ext
371saronson@glaukos.com
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