iStent® Trabecular Micro-Bypass Stent Reduced IOP and Medication Use in Predominately Hispanic Glaucoma Patient Population, According to Published Study

Case Series in Clinical Ophthalmology Reported Mean IOP of 12.9 mm Hg
and 61% Reduction in Mean Medication Burden 1 Year Following iStent
Implantation in Conjunction with Cataract Surgery

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–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,
today announced that a study of 134 predominantly Hispanic eyes with
open-angle glaucoma (OAG), published in Clinical Ophthalmology,
showed mean intraocular pressure (IOP) of 12.9 mm Hg and a 61% decrease
in mean medication burden one year following implantation of the iStent®
Trabecular Micro-Bypass Stent
in combination with cataract surgery.

The retrospective, consecutive case series includes 168 eyes of 128
patients who underwent iStent implantation with concomitant
cataract surgery, of which 134 eyes in 100 patients have been followed
through one year. Study researchers reported that 87% of subjects had
moderate to severe OAG and 80% were Hispanic, a population segment with
a higher-than-average incidence and prevalence of OAG. Up to 21% of
Hispanics are expected to develop OAG by age 80, according to a
reference cited in the study.

All procedures in the series were performed by Mark J. Gallardo, MD, at
a single site in El Paso, Texas. Before surgery, patients were placed
into three subgroups in accordance with the surgeon’s typical clinical
practice and based on the patient’s IOP level, medication burden and
treatment goal. In the 134 eyes with one-year postoperative follow-up,
the safety profile was favorable and treatment success was achieved in
all three subgroups as follows:

Group 1: Comprised of 65 eyes with controlled IOP on at least one
ocular hypotensive medication preoperatively and a treatment goal to
reduce medication burden while maintaining IOP control. One year
following the procedure, medication burden decreased from a mean of 2.4
medications preoperatively to 0.6 at one year; this decrease was
statistically significant (p<0.001). Further, mean IOP decreased to 12.7
mm Hg, compared to 13.6 mm Hg preoperatively.

Group 2: Comprised of 31 eyes with IOP not controlled on up to
two ocular hypotensive medications preoperatively and a treatment goal
to reduce IOP and maintain or reduce medication burden. One year
following the procedure, all eyes had IOP of 18 mm Hg or lower with a
statistically significant (p<0.001) reduction to a mean IOP of 12.6 mm
Hg, compared to 19.1 mm Hg preoperatively. Medication burden decreased
to a mean of 0.4 medications, compared to 1.1 preoperatively.

Group 3: Comprised of 40 eyes on three or more ocular hypotensive
medications and/or uncontrolled IOP preoperatively with a treatment goal
to reduce IOP in order to avoid filtering surgery. One year following
the procedure, 95% (38 of 40 eyes) achieved their treatment goal. In
these 38 eyes, mean IOP decreased to 13.6 mm Hg, compared to 19.3 mm Hg
preoperatively, which was statistically significant (p< 0.001).
Medication burden decreased to a mean of 1.8 medications, compared to
3.2 preoperatively.

“These data show that iStent in combination with cataract surgery
can effectively reduce IOP and topical ocular hypotensive medication use
in a mainly Hispanic patient population, including those with more
advanced disease,” said Dr. Gallardo. “Importantly, these results were
achieved in a real-life clinical setting, where the treatment goals
differ by patient, based on their individual needs and disease state.
The study’s high success rate overall and within each patient subgroup
underscores the tangible benefits of using trabecular bypass stenting to
manage IOP and medication burden in a demographically diverse glaucoma
patient population.”

The full Clinical Ophthalmology article is available online at

Typically associated with elevated IOP, glaucoma is characterized by
progressive, irreversible and largely asymptomatic vision loss caused by
optic nerve damage. It is a leading cause of blindness. According to
Market Scope, more than 80 million people worldwide have glaucoma,
including 4.5 million people in the United States. Open-angle glaucoma
is the most common form, affecting approximately 3.6 million people in
the United States.

The iStent was approved by the U.S. Food & Drug Administration
(FDA) in June 2012 and is indicated for use in conjunction with cataract
surgery for the reduction of IOP in adult patients with mild-to-moderate
open-angle glaucoma currently treated with ocular hypotensive
medication. The iStent is inserted through the trabecular
meshwork and into Schlemm’s canal, the eye’s drainage system, where it
restores the natural, physiological outflow of aqueous humor. Made of
surgical-grade non-ferromagnetic titanium that is coated with heparin,
the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos
believes it is the smallest medical device ever approved by the FDA.

About iStent Trabecular Micro-Bypass Stent (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

About Glaukos

Glaukos (
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 limitation, the
continued efficacy of our products as might be suggested in the study
described above. 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, 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
or at
In addition, information about the risks and benefits of our products is
available on our website at
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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
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Media Contact:
Pascale Communications
Cassandra Dump,

Glaukos Corporation
Sheree Aronson, 949-367-9600
ext 371
VP, Investor Relations