Surgeons to Present Recent Data and Clinical
Results at European Anterior Segment Conference
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, announced today that various Key Opinion
Leader (KOL) presentations and electronic posters will feature its
iStent® Trabecular Micro-Bypass and iStent inject® Trabecular
Micro-Bypass products at the upcoming European Society of Cataract
and Refractive Surgery (ESCRS) annual congress on October 7 – 11,
2017 in Lisbon, Portugal.
The yearly congress held by the ESCRS is a unique gathering of
physicians, ophthalmic industry leaders and others. The meeting
assists in sharing and advancing new and compelling data to
facilitate conversations regarding best practices, surgical pearls,
outstanding patient care, education and advocacy, and new and
upcoming technologies.
Presentations (Greenwich Mean Time,
GMT):
Monday, October 9, 2017Free Paper Session:
Glaucoma8:00 – 10:30, Room 4.1
- 9:18am – The iStent trabecular
micro-bypass stent reduces post cataract surgery intraocular
pressure (IOP) spikes in advanced glaucomaAuthors: G. Moussa, P.
Pandey, S. Begum, I. Masood
- 9:54am – MIGS with two second
generation trabecular bypass stents in eyes with primary open-angle
glaucoma on one preoperative medication: outcomes through two
yearsAuthors: K. Schargel, J. Belda Sanchis, J. Ruiz Colecha, J.
Campello
Electronic Posters (Viewable at eTerminals located in the
Poster Village)
- Outcomes in mild, moderate and severe
glaucoma through two years following phacoemulsification with
trabecular micro-bypass stent implantation in a predominantly
Hispanic populationAuthors: M. Gallardo, R. Supnet
- Treatment with two second-generation
trabecular micro-bypass stents and postoperative topical
prostaglandin in eyes with open-angle glaucoma taking two
preoperative medications: outcomes through 30 monthsAuthors: J.
Martinez de la Casa
- IOP reduction following iStent inject
implantation in primary open-angle glaucoma eyes depending on lens
condition and further previous surgeryAuthors: F. Ruefer, M.
Matthäi, J. Forster, T. Herbst, D. Holland
- Pilot series of Southeast Asian eyes
which underwent combined iStent trabecular micro-bypass device
implantation and cataract surgeryAuthors: C. Sng, S. Loon, P.
Chew
- Long-term titrated IOP control and
medication reduction following implantation of one, two, or three
trabecular micro-bypass stentsAuthor: L. Voskanyan
Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS), which
involves 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 IOP by restoring the natural outflow pathways
for aqueous humor. In 2012, Glaukos received FDA approval and
launched its first MIGS device, the iStent, which has been shown to
lower IOP in adult patients with mild-to-moderate open-angle
glaucoma.
The company’s next-generation MIGS device, the iStent inject
includes two stents preloaded in an auto-injection mechanism that
allows an ophthalmic surgeon to inject stents into multiple
locations of the trabecular meshwork through a single corneal
incision. The iStent inject has been approved in the European
Union, Australia, Brazil and Canada. Glaukos has U.S. IDE clinical
trials underway for the iStent inject for use in conjunction with
cataract surgery and for a similar product, the iStent SA™, for use
as a standalone procedure. Glaukos has also developed the iStent
Supra® Suprachoroidal Micro-Bypass Stent, which is designed to
reduce IOP by accessing the suprachoroidal space in the eye.
Approved in the European Union, the iStent Supra is also being
evaluated in a U.S. IDE clinical trial.
The company is also pursuing FDA approval of iDose™ Travoprost,
a drug-delivery system designed to elute therapeutic levels of
travoprost, a glaucoma drug, from within the anterior chamber for
extended periods of time.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor on October 7 –
10, 2017 in the FIL – Feira Internacional de Lisboa at booth
#P1128.
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 (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 of our products as might be suggested in the
presentations and posters 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 June 30, 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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version on businesswire.com: http://www.businesswire.com/news/home/20171005006196/en/
Glaukos CorporationInvestor ContactSheree
Aronson+1.949.481.0631saronson@glaukos.comorMedia
ContactCassandra
Dump+1.619.971.1887cassy@pascalecommunications.com
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