Study in Clinical Ophthalmology Reveals Mean
IOP of 15.17 mm Hg and 56% Reduction in Mean Glaucoma Medications 2
Years Following iStent Implantation in Combination with Cataract
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 a study published in
Clinical Ophthalmology showed that a consistent cohort of 107
open-angle glaucoma (OAG) eyes receiving the iStent® Trabecular
Micro-Bypass Stent in combination with cataract surgery achieved a
22% reduction in mean intraocular pressure (IOP) to 15.17 mm Hg and
a 56% reduction in mean ocular hypotension medications to 0.61 two
years following surgery.
The retrospective, consecutive case series includes 350 eyes
that underwent iStent implantation with concomitant cataract
surgery between October 2012 and December 2015. Study researchers
reported a favorable safety profile and postoperative follow-up of
all eyes is ongoing. All procedures were performed by John P.
Berdahl, MD, at a single site in Sioux Falls, South Dakota. The
series represents Dr. Berdahl’s typical clinical use of the iStent.
In this study, OAG subjects were defined as patients with primary
OAG, normal tension glaucoma and ocular hypertension, with no cases
excluded.
“Our data show that mild-to-moderate OAG patients receiving a
single iStent with cataract surgery can achieve sustained IOP
levels approaching 15 mm Hg and also reduce their dependence on
glaucoma medications,” said Dr. Berdahl. “These outcomes are
important because controlling IOP is the only proven treatment for
glaucoma and its management is often hindered by the poor
compliance, cost and side effects associated with topical ocular
hypotensive medications that patients must administer one or more
times a day for the rest of their lives.”
Study researchers indicated that, to their knowledge, this study
represents the largest sample size published to date regarding the
iStent in combination with cataract surgery. The full Clinical
Ophthalmology article is available online at
https://www.dovepress.com/clinical-evaluation-of-a-trabecular-microbypass-stent-with-phacoemulsi-peer-reviewed-article-OPTH.
Typically associated with elevated IOP, glaucoma is
characterized by progressive, irreversible and largely asymptomatic
vision loss caused by optic nerve damage. It is a leading cause of
blindness. 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.
The iStent was approved by the U.S. Food & Drug
Administration (FDA) in June 2012 and is indicated for use 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 inserted
through the trabecular meshwork and into Schlemm’s canal, the eye’s
drainage system, where it restores 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.
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, the
continued efficacy of our products as might be suggested in the
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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Glaukos CorporationMedia Contact:Cassandra Dump,
619-971-1887cassy@pascalecommunications.comorInvestor
Contact:Sheree Aronson, 949-367-9600 ext 371VP, Investor
Relationssaronson@glaukos.com
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