Pivotal Trial Results for Glaukos’ iStent inject® Published in Leading Ophthalmic Journal
In the study, 387 subjects were randomized to iStent inject in combination with cataract surgery and 118 subjects were randomized to cataract surgery only.
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
the U.S. Investigational Device Exemption (IDE) pivotal trial results
for its next-generation iStent inject®
Trabecular Micro-Bypass System have been published in Ophthalmology.
Results of the iStent inject prospective, randomized, controlled,
multicenter clinical trial, which included 505 mild-to-moderate primary
open-angle glaucoma (POAG) subjects from 41 investigational sites,
formed the basis for Food & Drug Administration approval of the device
in June 2018. In the study, 387 subjects were randomized to iStent
inject in combination with cataract surgery and 118 subjects were
randomized to cataract surgery only. Subjects were followed through 24
months with annual medication washouts.
The iStent inject met the study’s primary and secondary
effectiveness endpoints as follows:
-
At 24 months, 75.8% of the iStent inject cohort achieved a 20%
or greater reduction in unmedicated diurnal intraocular pressure
(DIOP), compared to 61.9% for the cataract-only cohort (p = 0.005). -
At 24 months, the mean reduction in unmedicated DIOP was 7.0 mmHg for
the iStent inject cohort, compared to 5.4 mmHg for the
cataract-only cohort (p < 0.001).
Through 24 months, the overall safety profile of iStent inject
was highly favorable, with the rate of adverse events for iStent
inject in combination with cataract surgery similar to cataract
surgery alone.
Additional key findings highlighted in the Ophthalmology article
include:
-
At 24 months, observed data show that the iStent inject cohort
achieved a 31% reduction in mean observed unmedicated DIOP to 17.1
mmHg from an unmedicated baseline DIOP of 24.8 mmHg. -
At 24 months, observed data show that 63.2% of the iStent inject
cohort achieved unmedicated mean DIOP at or below 18 mmHg, compared to
50.0% for the cataract-only cohort. -
At 23 months, observed data show that the iStent inject cohort
achieved a 75% reduction in the mean number of medications, compared
to 47% for the cataract-only cohort. -
At 23 months, of the responders, 84% of treatment eyes were medication
free, compared to 67% of the control eyes.
“These published results reinforce the performance and safety of iStent
inject, which now offers ophthalmic surgeons an important new
treatment option for effectively managing IOP in glaucoma patients while
potentially reducing or eliminating the need for topical hypotensive
medications,” said Thomas W. Samuelson, MD, a surgeon at Minnesota Eye
Consultants and Adjunct Professor at the University of Minnesota, as
well as trial investigator and author of the Ophthalmology article.
“The results of the U.S. IDE pivotal trial, along with the expanding
library of peer-reviewed clinical evidence, confirm that iStent
inject combined with phacoemulsification provides predictable,
clinically significant IOP reductions and an excellent safety profile
through an elegant, micro-invasive procedure with minimal tissue
disruption.”
“Publication of the iStent inject pivotal study in a leading
ophthalmic journal represents an important milestone for Glaukos,” said
Thomas Burns, Glaukos president and chief executive officer. “We
continue to be encouraged with the U.S. ophthalmic community’s response
to iStent inject. Surgeon feedback and emerging real-world
results in the U.S. mirror our experience in international markets and
continue to provide us with high confidence in the product’s prospects
and what it means for glaucoma surgeons and their patients.”
Glaukos commenced a U.S. commercial launch of iStent inject in
September 2018. The product is also commercially available in the
European Union, Armenia, Australia, Brazil, Canada, Hong Kong,
Singapore, South Africa and other international markets.
The iStent inject is designed to optimize the natural
physiological outflow of aqueous humor by creating two patent bypasses
through the trabecular meshwork, the main source of resistance in
glaucomatous eyes, resulting in multi-directional flow through Schlemm’s
canal. It includes two heparin-coated titanium stents preloaded into an
auto-injection system that allows the surgeon to precisely implant
stents into two trabecular meshwork locations through a single corneal
entry point in a straightforward click-and-release motion. The iStent
inject is the company’s next-generation trabecular micro-bypass
technology and is based on the same fluidic method of action as the
company’s first-generation pioneering iStent® Trabecular
Micro-Bypass Stent, which has been implanted in more than 450,000
eyes worldwide since its introduction in 2012 and has earned a
reputation of demonstrated efficacy with an excellent safety profile.
Each iStent inject stent is approximately 0.23 mm x 0.36 mm,
or about one-third the size of the first-generation iStent.
The company believes the iStent inject is the smallest
medical device ever approved by the FDA.
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 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
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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 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
year ended December 31, 2018. 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
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