According to Analysis Published in Journal of
Medical Economics, Cumulative Cost at Five Years was Lowest for
Two-Stent Procedure, Compared to Laser Treatment or Topical
Medication Only
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 analysis published
in the Journal of Medical Economics evaluating various options for
treating elevated intraocular pressure (IOP) in open-angle glaucoma
patients showed that two iStent® Trabecular Micro-Bypass Stents had
a lower projected average cumulative cost at five years than either
selective laser trabeculoplasty (SLT) or topical glaucoma
medication only.
The population-based, annual state-transition, probabilistic,
cost-of-care model used in the analysis was designed to assess
direct costs for three treatment options – two iStents, SLT or
topical medication only – over a five-year time horizon. A
clinician panel provided treatment strategy change probabilities
and direct costs for drugs, procedures and complications that were
included in the analysis.
According to the study authors, the projected average cumulative
cost at five years was $4,420 for the two-stent procedure, compared
to $4,730 for SLT and $6,217 for topical medication only. The model
showed that while the two-stent procedure had the highest initial
year cost, it also had the lowest annual marginal cost for each
subsequent year. Over the same time period, costs in each year
following SLT or topical medication only were more than double that
of the two-stent procedure.
“While numerous international studies have shown the ability of
two trabecular meshwork stents to effectively control IOP in
open-angle glaucoma patients, this analysis is the first to reveal
the potential cost efficiency of trabecular stenting, especially
over longer time horizons,” said John P. Berdahl, MD, a South
Dakota-based ophthalmic surgeon and one of the authors of the
Journal of Medical Economics article. “Our research indicates that
the two-stent treatment option may reduce glaucoma-related health
resource use and contribute to direct cost savings, particularly
when compared to topical medication only, which is the most
commonly used treatment option today but is often ineffective due
to high rates of patient non-compliance.”
Glaukos is the study sponsor and the pioneer of Micro-Invasive
Glaucoma Surgery, or MIGS. MIGS involves insertion of a micro-scale
device from within the eye’s anterior chamber through a small
corneal incision. MIGS devices are designed to reduce intraocular
pressure by restoring the natural outflow pathways for aqueous
humor. In 2012, Glaukos received U.S. Food & Drug
Administration (FDA) approval for the iStent, which is implanted in
conjunction with cataract surgery and has been shown to lower IOP
in adult patients with mild-to moderate open-angle glaucoma.
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 iStent
inject is approved for use in the European Union, Canada,
Australia, Singapore and Brazil. 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 core strategy is to provide a full complement of
micro-scale treatment options that can effectively manage IOP and
overcome many of the drawbacks of conventional therapies,” said
Thomas Burns, Glaukos president and chief executive officer.
“Peer-reviewed study results like these help to illustrate the
potential for our technologies to offer important clinical and
economic benefits for physicians, patients and the healthcare
system.”
The full Journal of Medical Economics article is available
here.
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 and cost efficiency 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 2016 and our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2017. 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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