Glaukos Corporation (NYSE: GKOS), an ophthalmic medical
technology and pharmaceutical company focused on the development
and commercialization of novel surgical devices and sustained
pharmaceutical therapies designed to transform the treatment of
glaucoma, announced today that its products will be included in
various physician presentations at the 36th Congress of the
European Society of Cataract and Refractive Surgeons (ESCRS) on
September 22-26, 2018, at the Messe Wien Exhibition and Congress
Center in Vienna, Austria.
The yearly ESCRS congress 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.
Key Presentations
(CEST):
Saturday, September 22Presented Poster
Session3:00-4:30pm, Poster Village, Pod 2
- 4:10pm – Evaluation of
second-generation trabecular micro-bypass stents in patients with
mild to severe glaucoma: a Canadian studyPresenting Author: P.
Harasymowycz
Sunday, September 23Free Paper Session: Cataract
Surgery and Glaucoma2:00-4:00pm, Room A3, Podium 1
- 2:30pm – A prospective randomized U.S.
IDE pivotal study of second-generation trabecular micro-bypass
stents implanted in conjunction with cataract surgeryPresenting
Author: T. Samuelson
- 2:58pm – Single-surgeon experience with
ab interno trabecular micro-bypass stent implantation with
concomitant cataract surgery in a predominantly Hispanic patient
population with primary open-angle glaucoma (OAG): two-year
outcomesPresenting Author: M. Gallardo
Monday, September 24Free Paper Session: Glaucoma and
Posterior Segment8:00-10:30am, Room A3, Podium 1
- 8:30am – Outcomes through 60 months
following standalone implantation of two trabecular micro-bypass
stents in eyes with OAG not controlled on one medicationPresenting
Author: E. Donnenfeld
Presented Poster Session9:30-11:00am, Poster Village, Pod
3
- 9:30am – Micro-Invasive Glaucoma
Surgery (MIGS) with second-generation trabecular micro-bypass
stents combined with topical prostaglandin in eyes with OAG on two
preoperative medications: 42-month outcomesPresenting Author: B.
Ang
E-Posters (Viewable at eTerminals located in the Poster
Village)
- Prospective, randomized Phase 2 study
evaluating the safety and efficacy of travoprost intraocular
implantsAuthor: R. Ang
- Long-term intraocular pressure (IOP)
control with one, two or three trabecular micro-bypass stents for
OAG: 54-month outcomesAuthor: A. Carceller Guillamet
- Single-surgeon experience with
second-generation trabecular micro-bypass stents: long-term
outcomes following implantation in patients with OAGAuthors: I.
Conrad-Hengerer, G. Auffarth
- Initial results after implantation of
second-generation trabecular micro-bypass stents in a combined
cataract and glaucoma procedureAuthor: K. Gundersen
- Treatment with standalone implantation
of two trabecular micro-bypass stents combined with topical
prostaglandin in OAG on two preoperative medications: five-year
outcomesAuthor: A. Junemann
- Evaluation of MIGS with trabecular
micro-bypass stents during cataract surgery in one of the largest
cohorts of single-surgeon reportsAuthor: E. Liang
- IOP reduction after combined phaco and
iStent inject in phakic eyes and standalone iStent inject in
pseudophakic eyes: preliminary resultsAuthors: M. Pavel, A.
Nagar
- MIGS with second-generation trabecular
micro-bypass stents in OAG on one preoperative medication: 42-month
outcomesAuthor: M. Toteberg-Harms
- Five-year outcomes of two trabecular
micro-bypass stents vs. prostaglandin in newly diagnosed OAGAuthor:
S. Vold
Glaukos pioneered 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 U.S. Food and Drug Administration (FDA)
approval and launched its first MIGS device, the iStent® Trabecular
Micro-Bypass Stent.
The company’s second-generation MIGS device, the iStent inject®
Trabecular Micro-Bypass System, was approved by the FDA in June
2018. 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 also been
approved in the European Union, Armenia, Australia, Brazil, Canada,
Hong Kong, Singapore and South Africa.
In addition, Glaukos is pursuing FDA approval for additional
MIGS surgical and sustained pharmaceutical therapy pipeline
products, all of which are investigational in the U.S.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor at booth
#B330.
About iStent inject Trabecular Micro-Bypass System
(U.S.)
Indication for Use: The iStent inject Trabecular Micro-Bypass
System Model G2-M-IS is indicated for use in conjunction with
cataract surgery for the reduction of IOP in adult patients with
mild-to-moderate primary open-angle glaucoma.
Contraindications: The iStent inject is contraindicated in eyes
with angle-closure glaucoma, traumatic, malignant, uveitic, or
neovascular glaucoma, discernible congenital anomalies of the
anterior chamber angle, retrobulbar tumor, thyroid eye disease, or
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 congenital anomalies of the angle, PAS, rubeosis, or
conditions that would prohibit adequate visualization of the angle
that could lead to improper placement of the stent and pose a
hazard.
MRI Information: The iStent inject is MR-Conditional, i.e., the
device is safe for use in a specified MR environment under
specified conditions; please see Directions for Use (DFU) label for
details.
Precautions: The surgeon should monitor the patient
postoperatively for proper maintenance of IOP. The safety and
effectiveness of the iStent inject have not been established as an
alternative to the primary treatment of glaucoma with medications,
in children, in eyes with significant prior trauma, abnormal
anterior segment, chronic inflammation, prior glaucoma surgery
(except SLT performed > 90 days preoperative), glaucoma
associated with vascular disorders, pseudoexfoliative, pigmentary
or other secondary open-angle glaucomas, pseudophakic eyes, phakic
eyes without concomitant cataract surgery or with complicated
cataract surgery, eyes with medicated IOP > 24 mmHg or
unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation
of more or less than two stents.
Adverse Events: Common postoperative adverse events reported in
the randomized pivotal trial included stent obstruction (6.2%),
intraocular inflammation (5.7% for iStent inject vs. 4.2% for
cataract surgery only), secondary surgical intervention (5.4% vs.
5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%).
Caution: Federal law restricts this device to sale by, or on the
order of, a physician. Please see DFU for a complete list of
contraindications, warnings, precautions, and adverse events.
For more information, visit www.glaukos.com.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic medical technology
and pharmaceutical company focused on the development and
commercialization of novel surgical devices and sustained
pharmaceutical therapies 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 inject, measuring 0.23 mm wide and 0.36 mm
long, 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
extent to which our products may obtain regulatory approval and
market acceptance, and the continued efficacy of our products as
might be suggested in the presentations at the ESCRS meeting. 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, 2018 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180921005019/en/
Glaukos CorporationInvestor ContactChris
LewisDirector, Investor Relations, Corporate Development &
Strategy+1-949-481-0510clewis@glaukos.comorMedia
ContactCassandra
Dump+1-619-971-1887cassy@pascalecommunications.com
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Glaukos (NYSE:GKOS)
Historical Stock Chart
From Apr 2023 to Apr 2024