Site icon pharmaceutical daily

Multiple Surgeons to Present Data on Glaukos Technologies at 2019 American Society of Cataract and Refractive Surgery

BusinessWire

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–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
numerous surgeons will present clinical trial and real-world data
regarding it products at the American Society of Cataract and Refractory
Surgery (ASCRS) Annual Meeting on May 3-7, 2019 at the San Diego
Convention Center in downtown San Diego, CA.

In addition, Glaukos is sponsoring an educational symposium in
conjunction with ASCRS and EyeWorld entitled “Utilizing the Latest in
MIGS Technology to Maximize Cataract Outcomes” on May 5, 2019 at
5:15-6:15 pm PDT in Hall E at the San Diego Convention Center. The
faculty includes Richard Lindstrom, MD (Moderator); John Berdahl, MD;
Blake Williamson, MD; and Elizabeth Yeu, MD. Go here
for more information and to register.

Glaukos will also be exhibiting on the showroom floor throughout ASCRS
at booth #3145.

KEY SURGEON PRESENTATIONS BY DAY AND TIME (PDT):

Saturday, May 4, 2019 – Location: Upper
Level, Room 7A

Sunday, May 5, 2019 – Location: Upper
Level, Room 7B

Sunday, May 5, 2019 – Location: Upper
Level, Room 5A

Monday, May 6, 2019 – Location: Upper
Level, Room 7A

Film and Poster Presentations Available
Throughout ASCRS

The ASCRS Annual Meeting is among the largest gatherings of anterior
segment physicians, medical personnel and industry executives in the
ophthalmic industry. All educational content of the ASCRS•ASOA Annual
Meeting is planned by its program committee, and ASCRS•ASOA does not
endorse, promote, approve, or recommend the use of any products, devices
or services.

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. Glaukos MIGS devices are 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, South Africa and other international markets. Glaukos is also
pursuing FDA approval for additional MIGS surgical and sustained
pharmaceutical therapy pipeline products, all of which are
investigational in the United States.

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 iStent® Trabecular
Micro-Bypass (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 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 launched its next-generation iStent inject device in the
United States in September 2018. Glaukos 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 and safety profile of our
products as might be suggested in the presentations at the ASCRS
meeting. These risks, uncertainties and factors are described in detail
under the caption “Risk Factors” and elsewhere in our Annual Report on
Form 10-K for the fiscal year ended December 31, 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.

Contacts

Media Contact:
Cassandra Dump
(619) 971-1887
Cassy@pascalecommunications.com

Investor Contact:
Chris Lewis
Director, Investor Relations,
Corporate Development & Strategy
(949) 481-0510
clewis@glaukos.com

Exit mobile version