Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical
and medical technology company focused on novel therapies for the
treatment of glaucoma, corneal disorders and retinal diseases,
announced today that its technologies will be featured in various
scientific programming at the American Academy of Ophthalmology
(AAO) annual meeting, being held October 18-21, 2024, in Chicago,
IL. Glaukos will be exhibiting onsite at booth #2608.
In addition, Glaukos is sponsoring an educational symposium in
conjunction with EyeWorld and AAO entitled, “iDose® TR: The Gateway
to Interventional Glaucoma” on Saturday, October 19, 2024, at
7:00-8:00 a.m. CT in the Grand Horizon EF Ballroom at the Marriott
Marquis McCormick Place. The faculty includes Ike Ahmed, MD; John
Berdahl, MD; Nathan Radcliffe, MD; Deborah Ristvedt, DO; and Savak
Teymoorian, MD. Go here for more information and to register.
Key Glaucoma Posters:
- John Berdahl, MD Effect of Travoprost Intracameral
Implant in Eyes with Prior Failed Selective Laser Trabeculoplasty
(SLT)
- Mohammed ElMallah, MD Travoprost Intracameral Implant
(iDose TR) Delivers Therapeutic Aqueous Humor Drug Levels and
Lowers IOP Over 24 Months
- Ali Salimi, MD A Decade-Long Outcome of Two
First-Generation Trabecular Micro-Bypass Stents with Cataract
Surgery in POAG
Key Corneal Health Presentations:
- 2:15-2:45 p.m., Weijie Lin, MD Risk Factors for
Complications After CXL for KCN
Abstract information can be found at
www.aao.org/annual-meeting.
The AAO Annual Meeting is among the largest gatherings of
ophthalmic physicians, medical personnel, and industry executives
in the ophthalmic industry. All educational content of the AAO
Annual Meeting is planned by its program committee, and AAO does
not endorse, promote, approve or recommend the use of any products,
devices or services.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and
medical technology company focused on developing and
commercializing novel therapies for the treatment of glaucoma,
corneal disorders and retinal diseases. Glaukos first developed
Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the
traditional glaucoma treatment paradigm, launching its first MIGS
device commercially in 2012. In 2024, Glaukos commenced commercial
launch activities for iDose TR, a first-of-its-kind, long-duration,
intracameral procedural pharmaceutical designed to deliver 24/7
glaucoma drug therapy inside the eye for extended periods of time.
Glaukos also markets the only FDA-approved corneal cross-linking
therapy utilizing a proprietary bio-activated pharmaceutical for
the treatment of keratoconus, a rare corneal disorder. Glaukos
continues to successfully develop and advance a robust pipeline of
novel, dropless platform technologies designed to meaningfully
advance the standard of care and improve outcomes for patients
suffering from chronic eye diseases.
About iDose® TR (U.S.)
iDose TR (travoprost intracameral implant) is a long duration
prostaglandin analog approved for a single administration and
indicated for the reduction of intraocular pressure (IOP) in
patients with open-angle glaucoma (OAG) or ocular hypertension
(OHT). Made from medical-grade titanium, iDose TR is implanted
through the trabecular meshwork and back wall of Schlemm's canal,
directly into scleral tissue. Once implanted, 75 mcg of a novel,
preservative-free, proprietary formulation of travoprost
continuously elutes into the anterior chamber via
membrane-controlled diffusion, allowing for 24/7 release of
medication.
Indication for Use: iDose TR (travoprost intracameral implant)
is indicated for the reduction of intraocular pressure (IOP) in
patients with open angle glaucoma (OAG) or ocular hypertension
(OHT).
Dosage and Administration: For ophthalmic intracameral
administration. The intracameral administration should be carried
out under standard aseptic conditions.
Contraindications: iDose TR is contraindicated in patients with
active or suspected ocular or periocular infections, patients with
corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal
guttatae), patients with prior corneal transplantation, or
endothelial cell transplants (e.g., Descemet’s Stripping Automated
Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity
to travoprost or to any other components of the product.
Warnings and Precautions: iDose TR should be used with caution
in patients with narrow angles or other angle abnormalities.
Monitor patients routinely to confirm the location of the iDose TR
at the site of administration. Increased pigmentation of the iris
can occur. Iris pigmentation is likely to be permanent.
Adverse Reactions: In controlled studies, the most common ocular
adverse reactions reported in 2% to 6% of patients were increases
in intraocular pressure, iritis, dry eye, visual field defects, eye
pain, ocular hyperaemia, and reduced visual acuity.
About iStent inject® W Trabecular Micro-Bypass System
(U.S.)
Indication for Use: The iStent inject W Trabecular Micro-Bypass
System Model G2-W is indicated for use in conjunction with cataract
surgery for the reduction of intraocular pressure (IOP) in adult
patients with mild to moderate primary open-angle glaucoma.
Contraindications: The iStent inject W is contraindicated in
eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or
neovascular glaucoma, discernible congenital anomalies of the
anterior chamber (AC) 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 W 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 W 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 iStent inject 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.
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
timing and extent to which obtain regulatory approval for
investigational products, our ability to successfully commercialize
such products, the ability to obtain and maintain adequate
financial coverage and reimbursement for our products, and the
continued efficacy and safety profile of our products as might be
suggested in the presentations at the AAO meeting. These and other
risks, uncertainties and factors related to Glaukos, and our
business are described in detail under the caption “Risk Factors”
and elsewhere in our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2024, which was filed with the Securities and
Exchange Commission (SEC) on August 2, 2024. Our filings with the
SEC 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: https://www.businesswire.com/news/home/20241014933684/en/
Media Contact – Glaucoma: Melissa Roy (978) 758-1365
mroy@jpa.com
Media Contact – Corneal Health: Michele Gray (917) 449-9250
michele@mgraycommunications.com
Investor Contact: Chris Lewis Vice President, Investor Relations
& Corporate Affairs (949) 481-0510 clewis@glaukos.com
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