Newly Diagnosed Primary Open-Angle Glaucoma
Patients Who Received 2 iStents Achieved 43% Reduction in Mean
Intraocular Pressure through 36 Months Following Standalone
Surgery
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 an international study
published in the current issue of Ophthalmology and Therapy showed
that newly diagnosed primary open-angle glaucoma patients achieved
a 43% reduction in mean intraocular pressure (IOP) to 14.6 mm Hg
through 36 months following implantation of two iStent® Trabecular
Micro-Bypass stents in a standalone procedure.
In this prospective study conducted by multiple ophthalmic
surgeons at a single investigational site, 101 phakic subjects with
primary open-angle glaucoma that had not undergone prior glaucoma
treatment of any kind were randomized in a 1:1 ratio to receive
either two iStents in a standalone procedure or topical ocular
hypotensive medication therapy (travoprost). Phakic refers to eyes
that have not undergone prior cataract surgery and contain a
natural lens. The study is designed for follow-up of all subjects
through five years. Through 36 months, study results showed:
- Mean IOP in the stent group (n=39)
declined 43% from 25.5 mm Hg to 14.6 mm Hg, while mean IOP in the
travoprost group (n=34) declined 39% from 25.1 mm Hg to 15.3 mm
Hg.
- 11% of eyes in the stent group required
additional topical medication therapy, compared to 23% in the
travoprost group.
- 91% of eyes in the stent group had IOP
≤ 18 mm Hg without additional topical medication therapy, compared
to 79% of eyes in the travoprost group; 62% of eyes in the stent
group had IOP ≤ 15 mm Hg without additional topical medication
therapy, compared to 21% of eyes in the travoprost group.
“We embarked on this study to assess the potential utility of
iStent as an initial treatment in naïve open-angle glaucoma
patients versus topical travoprost, which is a commonly prescribed
first-line medication therapy,” said Steven D. Vold, MD.
“Three-year safety and efficacy data are promising and show that
two iStents achieved sustained IOP reduction, with fewer subjects
requiring additional topical medication therapy compared to topical
travoprost. These results indicate that iStent implantation as
initial therapy in newly diagnosed glaucoma patients may be a
viable alternative to topical ocular hypotensive medications, which
are often associated with high rates of non-compliance, side
effects and/or ocular surface damage.”
The article may be accessed online at
http://link.springer.com/article/10.1007%2Fs40123-016-0065-3.
Approved by the U.S. Food & Drug Administration (FDA) in
2012, iStent is indicated for use in the United States in
conjunction with cataract surgery for the reduction of IOP in adult
patients with mild-to-moderate open-angle glaucoma currently
treated with ocular hypotensive medication. The iStent is the
industry’s first Micro-Invasive Glaucoma Surgery (MIGS) device. It
is inserted from within the anterior chamber through the trabecular
meshwork and into the eye’s drainage canal, known as Schlemm’s
canal, where it is designed to restore the natural physiological
outflow of aqueous humor. Made of surgical-grade non-ferromagnetic
titanium that is coated with heparin, the iStent is approximately
1.0 mm long and 0.33 mm wide. Glaukos believes it is the smallest
medical device ever approved by the FDA.
The company’s next-generation MIGS device, the iStent inject®
Trabecular Micro-Bypass Stent includes two stents preloaded in an
auto-injection mechanism that allows an ophthalmic surgeon to
inject stents into multiple trabecular meshwork locations through a
single corneal entry point. The iStent inject has been approved in
the European Union, Australia and Canada. The iStent inject is for
investigational use only in the United States, with two IDE
clinical trials underway for two versions of the product, one for
use in conjunction with cataract surgery and another for use as a
standalone procedure.
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 limitation, our
ability to receive additional approvals of our products, including,
without limitation, the iStent inject® Trabecular Micro-Bypass
Stent, by the FDA and other regulatory bodies; and the continued
efficacy of our products as might be suggested in the international
study described 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 Quarterly Report on Form 10-Q for the quarter ended
June 30, 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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for 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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