iStent inject Achieved 42% Reduction in Mean IOP to 14.6 mmHg and 82%
Reduction in Mean Medications to 0.55 at 3 Years Postoperative with
Favorable Safety Profile in Real-World Cohort
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
results of an independent, international study published in Advances
in Therapy showed standalone implantation of the iStent inject®
Trabecular Micro-Bypass System in eyes with substantial glaucoma
disease burden achieved a 42% reduction in mean intraocular pressure
(IOP) to 14.6 mmHg and an 82% reduction in mean medications to 0.55 at
three years postoperative.
This prospective, consecutive case series of 44 eyes was conducted to
evaluate the long-term outcomes of the two-stent iStent inject
system as a sole procedure in predominantly primary open-angle glaucoma
subjects with considerable disease burden. The cohort’s preoperative
mean IOP was 25.3 mmHg on a mean of 2.98 ocular hypotensive medications,
with 75% of eyes on three to five medications and no eyes
medication-free. Moreover, 50% of eyes had a history of prior glaucoma
surgery.
All iStent inject procedures were performed by Fritz H. Hengerer,
MD, PhD at an academic ophthalmology center in Heidelberg, Germany.
Additional results of eyes with three-year follow-up showed:
-
Mean IOP ≤ 18 mmHg was achieved by 97% of eyes vs. 9.1% preoperatively
(p<0.0001), and mean IOP ≤ 15 mmHg was achieved by 70% of eyes vs.
2.3% preoperatively (p<0.0001). - IOP decreased ≥ 20% vs. preoperative measurements in 88% of eyes.
-
Sixty-one percent of eyes were medication free and all eyes maintained
or decreased their three-year medication burden vs. preoperative
levels. -
The safety profile was favorable, with minimal adverse events and
stable corrected distance visual acuity reported.
“The results of this study highlight the profound efficacy and safety
profile of iStent inject as a sole procedure in a glaucoma
patient population with substantial disease burden,” said Dr. Hengerer,
the study’s author. “Of particular note is the very high portion of eyes
– 97% – that achieved IOP at or below 18 mmHg at three years
postoperative. This finding is key to our fundamental clinical goal of
preserving glaucoma patients’ vision because reaching this IOP threshold
is known to be associated with lessened visual field decline.”
Certain data from this study have been presented previously at
professional ophthalmic meetings in the United States and Europe. The
full article in Advances in Therapy may be accessed online here.
“While iStent inject has been studied primarily in patients with
mild-to-moderate open-angle glaucoma, Dr. Hengerer’s results add to an
emerging body of evidence suggesting that our multiple-stent technology
may also be a viable option for patients with more advanced disease,
including those who have undergone prior surgeries,” said Thomas Burns,
Glaukos president and chief executive officer. “Results like these
further strengthen our resolve to advance our strategy to provide
ophthalmic surgeons and their patients a comprehensive suite of
injectable, micro-scale solutions capable of addressing a full range of
glaucoma progression and disease states.”
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.
Glaucoma is characterized by progressive, irreversible vision loss
caused by optic nerve damage. There is no cure for the disease. However,
by reducing the eye pressure, the only proven effective treatment,
vision may be stabilized. Based on analysis of population-based surveys,
medical claims data and other statistics, the company estimates that
there are approximately 5.4 million people in the U.S. with primary
open-angle glaucoma, the most common form of the disease.
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 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
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
continued efficacy and safety profile of our products, as well as the
potential applications of our products as might be suggested in the
published research referenced 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 Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and our Quarterly Report on Form 10-Q for the first
quarter ended March 31, 2019. 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