Company Achieves Randomization Goal with 505
Patients
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 the completion of patient
enrollment in the pivotal phase of its U.S. Food and Drug
Administration (FDA) Investigational Device Exemption (IDE) trial
for the iStent SUPRA® Suprachoroidal Micro-Bypass Stent.
The iStent SUPRA prospective, randomized clinical trial includes
36 sites and 505 subjects with mild-to-moderate primary open-angle
glaucoma and cataracts. Subjects were randomized to receive either
iStent SUPRA in combination with cataract surgery or cataract
surgery alone. The study has a 24-month primary outcome measure of
a 20% or greater reduction in intraocular pressure (IOP) from
baseline. The results of the trial are expected to form the basis
for the company’s future Pre-Market Approval (PMA) submission to
the FDA.
The iStent SUPRA is designed to reduce IOP by accessing the
suprachoroidal space in the eye. Also known as the unconventional
pathway, this area is responsible for approximately 20% of aqueous
fluid outflow. Approximately 4.0 mm in length and curved to follow
the eye’s anatomy, the iStent SUPRA is already approved for
marketing in the European Union and certain other countries outside
the United States.
“We expect the iStent SUPRA to ultimately be an important part
of ophthalmic surgeons’ armamentarium for effectively managing
IOP,” said Thomas Burns, Glaukos president and chief executive
officer. “Achieving this enrollment milestone represents an
important step forward in our goal to provide surgeons and their
patients a comprehensive set of options to address a range of
glaucoma disease state and progression.”
Glaukos pioneered Micro-Invasive Glaucoma Surgery, or MIGS, and
introduced the industry’s flagship MIGS device, the iStent®
Trabecular Micro-Bypass Stent, in 2012. The iStent accesses the
eye’s conventional pathway for aqueous humor outflow, which is
through the trabecular meshwork and into Schlemm’s canal. The
company is also conducting FDA clinical trials for two versions of
its next-generation iStent inject® Trabecular Micro-Bypass Stent,
one version to be used in combination with cataract surgery and the
other version to be used in 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
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 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, the
continued efficacy of our products and the extent to which we may
obtain regulatory approval for any of the products discussed
herein; the extent to which the iStent SUPRA will meet its primary
outcome measure or receive FDA approval; the extent to which the
iStent SUPRA clinical trial will establish efficacy or safety; and
the extent to which the company will be able to achieve its goal of
providing glaucoma surgeons and patients a comprehensive set of
options to address a range of glaucoma disease states and
progression. 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,
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/20170216005253/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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