Glaukos Corporation (NYSE: GKOS), an ophthalmic medical
technology company focused on development and commercialization of
breakthrough products and procedures designed to transform the
treatment of glaucoma, announced today that its products will be
featured in various presentations during the annual American
Academy of Ophthalmology (AAO) meeting in Chicago, IL, at McCormick
Place convention center on October 15–18, 2016.
Glaukos is sponsoring an educational symposium for surgeons
entitled “The Complete MIGS Procedure” on Saturday, October 15,
2016, from 5:30 – 7:30 p.m. (CDT) in the Grand Ballroom at the
Renaissance Chicago Downtown Hotel. Faculty includes Kerry Solomon,
MD; Ike Ahmed, MD; Robert Cionni, MD; Steve Sarkisian, MD; and
Jeffrey Whitman, MD.
In addition, Glaukos technologies will be the subject of three
scientific poster presentations on Monday, October 17, 2016, as
follows:
12:30 p.m. – 2:00 p.m. (CDT), Location:
Hall A:
- Mark Gallardo, MD – Poster #PO386:
Efficacy of Trabecular Microbypass in Conjunction With Cataract
Surgery in a Predominately Hispanic Patient Population Primarily
Suffering From Moderate to Severe Open-Angle Glaucoma
- Fritz Hengerer, MD – Poster #PO389:
Second-Generation Trabecular Micro-Bypass Stents in Open-Angle
Glaucoma Patients With or Without Prior Glaucoma Surgery
- Shi Tan, MBCHB – Poster #PO405:
Manchester iStent Study: Five-Year Results and Cost Analysis
Glaukos will be exhibiting at booth 626 on the showroom floor
for the duration of the meeting.
Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS), which
involves the insertion of a micro-scale device from within the
eye's anterior chamber through a small corneal incision. The MIGS
device is 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 and
launched the flagship MIGS device, the iStent Trabecular
Micro-Bypass Stent®, which has been shown to lower intraocular
pressure in adult patients with mild-to-moderate open-angle
glaucoma undergoing cataract surgery.
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. Glaukos has also
developed the iStent Supra® Suprachoroidal Micro-Bypass Stent,
which is designed to reduce intraocular pressure by accessing the
suprachoroidal space in the eye and is approved in the European
Union. The iStent inject is for investigational use only in the
United States, with two IDE clinical trials underway for two
versions of the device, one for use in conjunction with cataract
surgery and another for use in a standalone procedure. An IDE
clinical trial is also underway for the iStent Supra, which is for
investigational use only in the United States.
About iStent® Trabecular Micro-Bypass
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 Corporation
Glaukos 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. (www.glaukos.com)
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 and
iStent Supra, by the FDA and other regulatory bodies; and the
continued efficacy of our products as might be suggested in the
symposium and poster presentations at AAO. These and other known
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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version on businesswire.com: http://www.businesswire.com/news/home/20161006005208/en/
Media Contact:Pascale CommunicationsCassandra Dump, (619)
971-1887Cassy@pascalecommunications.comorInvestor
Contact:Glaukos CorporationSheree Aronson, (949) 367-9600, Ext.
371saronson@glaukos.com
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