Company Revises 2017 Net Sales Guidance
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, will provide an overview of its growth
strategy and market opportunity, update progress of its innovative
pipeline products and revise 2017 net sales guidance during its
Investor Day meeting today in New York City.
“As the founder and pioneer of Micro-Invasive Glaucoma Surgery
(MIGS), we see tremendous future potential for Glaukos to leverage
our market-expanding portfolio of injectable iStent® MIGS devices
and novel iDose® drug delivery system,” said Thomas Burns, Glaukos
president and chief executive officer. “With core competencies in
micro-engineering design and manufacturability, drug formulation,
regulatory strategy and commercial execution, we are building
robust technology platforms to facilitate our transformation into a
glaucoma-centric pharmaceutical-device company focused on important
clinical needs aimed at driving sustained, longer-term growth.”
Key Pipeline Developments
Among the topics Glaukos management will discuss today are the
following updates about its iDose Travoprost and iStent pipeline
products:
iDose Travoprost:
The company will provide an overview of the preliminary efficacy
and safety results from the U.S. Investigational New Drug (IND)
Phase II clinical trial to evaluate the reduction of intraocular
pressure (IOP) by its Travoprost Intraocular Implant with the iDose
delivery system in patients with open-angle glaucoma. Implanted
during a micro-invasive procedure, the iDose Travoprost is designed
to continuously elute therapeutic levels of medication from within
the eye for extended periods of time. It is filled with a special
formulation of travoprost, a prostaglandin analog used to reduce
IOP, and capped with a membrane designed for continuous controlled
drug elution into the anterior chamber. When depleted, the iDose
Travoprost can be removed and replaced in a similar, subsequent
procedure.
The purpose of the 154-patient, multi-center, randomized,
double-blind Phase II trial is to evaluate two models of the iDose
delivery system with different travoprost elution rates, compared
to topical timolol maleate ophthalmic solution, 0.5%. Preliminary
results showed that both models of the iDose Travoprost are
currently achieving an approximate 8 mm Hg reduction in mean IOP in
the cohort of patients followed through nine months postoperative.
In addition, the preliminary study results showed a favorable
safety profile for iDose Travoprost, with no incidents of hyperemia
reported.
“These preliminary results are very encouraging and illustrate
the potential for iDose Travoprost to achieve significant duration
of effect and provide a favorable safety profile, which are
critical factors to effectively addressing the ubiquitous problem
of patient non-adherence to topical glaucoma medication regimens,”
said Mr. Burns. “We look forward to working with the FDA to
continue the IND evaluation process.”
The Phase II iDose Travoprost trial design calls for subjects to
be followed through three years. Glaukos expects to review the
iDose Travoprost results with the FDA in the fourth quarter and to
commence Phase III trials in early 2018.
iStent infinite™:
The company will announce plans to pursue U.S. FDA approval of
iStent infinite, a three-stent trabecular bypass standalone
solution for refractory open-angle glaucoma patients. In the fourth
quarter of 2017, the company expects to submit an Investigational
Device Evaluation (IDE) filing with the FDA, with plans to conduct
a one-year clinical study of approximately 65 subjects, followed by
a 510(k) submission.
“By addressing the needs of refractory glaucoma patients, the
iStent infinite will round out our industry-leading portfolio of
MIGS devices, designed to restore natural physiological outflow
through an elegant, facile procedure,” said Mr. Burns. “We expect
the iStent infinite to be an attractive alternative to invasive,
late-stage glaucoma surgeries that often subject patients to high
failure and complication rates.”
The iStent infinite will be intended for patients whose IOP is
uncontrolled by maximal medication therapy or incisional surgeries
such as trabeculectomies or tube shunt implantation. An
international case series of 30 subjects – including 27 with prior
trabeculectomies – showed that three trabecular bypass stents
implanted in a standalone procedure provided a 52% reduction in
mean IOP to 13.7 mm Hg at 12 months postoperative. Over the same
one-year period, subjects achieved a 77% reduction in the mean
number of topical medications used, to 0.43 postoperative vs. 1.83
preoperatively.
2017 Guidance
At today’s Investor Day, Glaukos management will also discuss
revisions to its 2017 net sales guidance. The company is revising
its guidance for third quarter and full year 2017 net sales to a
range of $38 million to $40 million and $155 million to $160
million, respectively. This compares to prior guidance of $41
million to $43 million for the third quarter and $162 million to
$167 million for the full year 2017. The revised guidance reflects
the company’s current assessment of certain transitory impacts to
iStent procedure volumes, including commercial carrier
reimbursement, recent hurricanes and reimbursement changes in
Australia, together with less transitory factors, including new
MIGS competition entering the market.
Investor Day and Webcast Information
The company will host its Investor Day meeting today in New York
City, beginning at 8 a.m. EDT and concluding at approximately 11:30
a.m. EDT. A live webcast of the meeting, including slide
presentations, will be available on the Glaukos website at
http://investors.glaukos.com. An archived replay will also be
available on the website following the meeting.
About Glaukos
Glaukos (www.glaukos.com) 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. These
forward-looking statements include our expectations about our iDose
Travoprost and iStent infinite pipeline products and our financial
guidance for the third quarter and full year 2017. 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,
uncertainties about our ability to maintain profitability; our
dependence on the success and market acceptance of the iStent; our
ability to leverage our sales and marketing infrastructure to
increase market penetration and acceptance both in the United
States and internationally of our products; our dependence on a
limited number of third-party suppliers for components of our
products; the occurrence of a crippling accident, natural disaster
or other disruption of our business and at our primary facility,
which may materially affect our manufacturing capacity and
operations; maintaining adequate coverage or reimbursement by
third-party payors for procedures using the iStent or other
products in development; our ability to properly train, and gain
acceptance and trust from, ophthalmic surgeons in the use of our
products; our ability to successfully develop and commercialize
additional products; our ability to compete effectively in the
highly competitive and rapidly changing medical device industry and
against current and future competitors (including MIGS competitors)
that, in some cases, are large public companies or divisions of
publicly traded companies that have competitive advantages; the
timing, effect and expense of navigating different regulatory
approval processes as we develop additional products and penetrate
foreign markets; the impact of any product liability claims against
us and any related litigation; the effect of the extensive and
increasing federal and state regulation in the healthcare industry
on us and our suppliers; the lengthy and expensive clinical trial
process and the uncertainty of outcomes from any particular
clinical trial; our ability to protect, and the expense and
time-consuming nature of protecting, our intellectual property
against third parties and competitors that could develop and
commercialize similar or identical products; the impact of any
claims against us of infringement or misappropriation of third
party intellectual property rights and any related litigation; and
the market’s perception of our limited operating history as a
public company. These and other known 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 2016 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170914005466/en/
Glaukos CorporationSheree AronsonVP, Investor Relations(949)
481-0361saronson@glaukos.com
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