AMA CPT® Editorial Panel Action Applies to
Codes Describing Trabecular Meshwork and Suprachoroidal Stent
Procedures
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 the Current Procedural
Terminology (CPT) Editorial Panel of the American Medical
Association has granted five-year extensions to three Category III
CPT codes that describe insertion of aqueous drainage devices into
the anterior chamber of the eye using Micro-Invasive Glaucoma
Surgery (MIGS).
CPT codes are used by physicians and other healthcare providers
to report and receive Medicare reimbursement for healthcare
services. In consultation with and with the support of the American
Academy of Ophthalmology, American Glaucoma Society and American
Society of Cataract and Refractive Surgery, Glaukos requested and
received extensions through December 31, 2023 on the following
Category III CPT codes:
- 0191T, which describes insertion of an
initial anterior segment aqueous drainage device such as the
company’s iStent® Trabecular Micro-Bypass Stent and iStent inject®
Trabecular Micro-Bypass Stent into the trabecular meshwork. The
iStent was approved by the U.S. Food & Drug Administration
(FDA) and launched in 2012. The iStent inject is currently being
evaluated in U.S. clinical trials and has not been approved by the
FDA.
- 0253T, which describes insertion of an
anterior segment aqueous drainage device such as the company’s
iStent SUPRA® Suprachoroidal Micro-Bypass Stent into the
suprachoroidal space. The iStent SUPRA is currently being evaluated
in U.S. clinical trials and has not been approved by the FDA.
- 0376T, which is an add-on code that
describes insertion of additional anterior segment aqueous drainage
devices, as with the iStent inject.
“The AMA CPT Editorial Panel’s decision to grant these
extensions is important to the continued surgeon adoption of iStent
and MIGS, a new technology class we pioneered to provide glaucoma
patients a viable potential alternative to daily, multi-dose
prescription eye drops or complex surgeries,” said Thomas Burns,
Glaukos president and chief executive officer. “As we pursue FDA
approval of our next-generation iStent technologies, we are pleased
to have the corresponding CPT codes already in place and will use
this time to continue to build upon the growing body of published
research that documents their clinical performance.”
The iStent, which is the industry’s flagship MIGS device, is
inserted through the trabecular meshwork and into Schlemm’s canal
via a small corneal incision made during cataract surgery. Once in
place, it is designed to restore the natural, physiological outflow
of aqueous fluid and reduce intraocular pressure (IOP). The company
is also pursuing FDA approval of two versions of its
next-generation iStent inject 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 for
IOP reduction. The company is also pursuing FDA approval of a third
MIGS device, the iStent SUPRA, which accesses a secondary pathway
for aqueous humor outflow.
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 we may obtain reimbursement coverage
from Medicare or commercial payers for procedures involving our
technologies; 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 Annual Report on Form 10-K for 2016, which was filed
with the Securities and Exchange Commission on March 15, 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 AronsonVP, Investor Relations(949) 367-9600 ext
371saronson@glaukos.com
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