- Alcon will leverage its global footprint and leadership in
ophthalmology to drive future growth, bringing this innovative
device to more patients worldwide
- Ivantis associates, including manufacturing and sales, are
immediately integrated into Alcon to ensure continuity for new and
existing customers
- Differentiated five-year data demonstrating clinical impact
will be showcased at 2022 medical meetings
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, today announced the closing of
its previously announced acquisition of Ivantis®, developer of the
novel Hydrus® Microstent, a minimally invasive glaucoma surgery
(MIGS) device designed to lower eye pressure for open-angle
glaucoma patients in connection with cataract surgery.*
With this acquisition, the immediate integration of Ivantis
associates helps ensure continuity of the business and
relationships with existing customers. It also allows Alcon to
begin its future growth plans to bring Hydrus Microstent to more
international markets and prioritize its ongoing evidence-based
research.
“We believe this transaction will further strengthen our global
surgical portfolio and help provide a platform for more growth in
the glaucoma space,” said David Endicott, CEO of Alcon. “As we
welcome Ivantis associates into Alcon, we look forward to
introducing Hydrus Microstent on a broader, global scale in the
near future to help even more patients see brilliantly.”
Longstanding clinical safety and efficacy data, which will be
highlighted at 2022 medical meetings, is a cornerstone of Hydrus
Microstent and its market adoption to date. Its five-year HORIZON
data demonstrated clinically meaningful and statistically
significant clinical benefits over the full five years, including
sustained reduction in medication use and the need for invasive
secondary glaucoma surgery. The safety profile was also sustained
through the five-year follow-up.1
“This is an important time for Hydrus Microstent as we continue
to learn more about its long-term efficacy and outcomes for
glaucoma patients worldwide. The visual field data recently
showcased at the American Academy of Ophthalmology annual meeting
showed Hydrus Microstent as the first MIGS device to demonstrate a
reduced rate of visual field loss compared to cataract surgery
alone. This is an important milestone for surgeons and their
patients,” said Dr. Ike Ahmed, Research Director at Kensington Eye
Institute, Director of the Glaucoma and Advanced Anterior Segment
Surgery (GAASS) Fellowship Program at the University of Toronto,
and Professor of Ophthalmology and Visual Sciences at the
University of Utah’s John A. Moran Eye Center. “I am confident that
Alcon’s acquisition of Ivantis will help drive even more research
and adoption of Hydrus Microstent.”
Continuing this rigorous ongoing research, Alcon plans to pursue
stand-alone surgery indications for Hydrus Microstent in the U.S.
with clinical trials underway and additional information about
potential expansion plans will be provided in the future.
In the U.S., Hydrus Microstent, which is part of a large and
growing market, is currently indicated for the reduction of
intraocular pressure in adult patients with mild to moderate
primary open-angle glaucoma in conjunction with cataract surgery.
In the U.K., Canada, Australia, Singapore and Germany, the device
is indicated for primary open-angle glaucoma in conjunction with
cataract surgery and as a stand-alone procedure.
About Alcon
Alcon helps people see brilliantly. As the global leader in eye
care with a heritage spanning more than seven decades, we offer the
broadest portfolio of products to enhance sight and improve
people’s lives. Our Surgical and Vision Care products touch the
lives of more than 260 million people in over 140 countries each
year living with conditions like cataracts, glaucoma, retinal
diseases, and refractive errors. Our more than 23,000 associates
are enhancing the quality of life through innovative products,
partnerships with Eye Care Professionals and programs that advance
access to quality eye care. Learn more at www.alcon.com.
About Hydrus Microstent
Roughly the size of an eyelash, the Hydrus Microstent is a
next-generation MIGS device designed to reduce eye pressure by
reestablishing flow through Schlemm's canal, the eye's natural
outflow pathway. When placed in the canal during minimally invasive
microsurgery, the device restores the flow of fluid in the eye,
using a Tri-Modal® mechanism of action: the Hydrus Microstent
dilates and scaffolds Schlemm's canal to augment outflow of aqueous
humor from the anterior chamber. It maintains an opening through
the trabecular meshwork from the anterior chamber into Schlemm's
canal. Its length spans approximately 90 degrees of the canal to
provide consistent access to multiple fluid collector channels in
the eye. Approved by the FDA in August 2018 for use in conjunction
with cataract surgery, the Hydrus Microstent is one of the most
rigorously researched and thoroughly studied MIGS devices.
References
- Ahmed, I.K. (2021, Mar. 4-7). 5 Year Follow Up from the HORIZON
Trial. American Glaucoma Society Virtual Annual Meeting.
- Gazzard et al. AGS 2022 Abstract (in review).
*Currently approved for stand-alone use and commercialized in
the U.K., Canada, Australia, Singapore and Germany.
Forward-looking
Statements
This press release contains, and our officers and
representatives may from time to time make, certain
“forward-looking statements” within the meaning of the safe harbor
provisions of the US Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words such
as: “anticipate,” “intend,” “commitment,” “look forward,”
“maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,”
“project,” “estimate,” “expect,” “strategy,” “future,” “likely,”
“may,” “should,” “will” and similar references to future periods.
Examples of forward-looking statements include, among others,
statements Alcon makes regarding its plans and decisions relating
to the acquisition of Ivantis Inc. and the manufacture,
distribution, marketing and/or sale of the Hydrus® Microstent; the
ability of Alcon to execute on these plans; market growth
assumptions; and generally, its expectations concerning its future
performance.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
Alcon’s current beliefs, expectations and assumptions regarding the
future of its business, future plans and strategies, and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties and risks that
are difficult to predict such as: the effect of the COVID-19
pandemic as well as other viral or disease outbreaks and the
availability and the public’s acceptance of vaccines; the
commercial success of its products and its ability to maintain and
strengthen its position in its markets; the success of its research
and development efforts, including its ability to innovate to
compete effectively; its success in completing and integrating
strategic acquisitions; the possibility that various closing
conditions for the transaction may not be satisfied or waived,
including that a governmental entity may prohibit, delay or refuse
to grant approval for the consummation of the transaction;
transaction costs; pricing pressure from changes in third party
payor coverage and reimbursement methodologies; global and regional
economic, financial, legal, tax, political, and social change; data
breaches or other disruptions of its information technology
systems; ongoing industry consolidation; its ability to properly
educate and train healthcare providers on its products; changes in
inventory levels or buying patterns of its customers; the impact of
a disruption in its global supply chain or important facilities;
ability to service its debt obligations; its ability to comply with
the US Foreign Corrupt Practices Act of 1977 and other applicable
anti-corruption laws, particularly given that it has entered into a
three-year Deferred Prosecution Agreement with the US Department of
Justice; uncertainty and impact relating to the potential phasing
out of LIBOR and transition to alternative reference rates; the
need for additional financing through the issuance of debt or
equity; its reliance on outsourcing key business functions; its
ability to protect its intellectual property; the impact of
unauthorized importation of its products from countries with lower
prices to countries with higher prices; uncertainties regarding the
success of Alcon's separation and Spin-off from Novartis and the
subsequent transformation program, including the expected
separation and transformation costs, as well as any potential
savings, incurred or realized by Alcon; the effects of litigation,
including product liability lawsuits and government investigations;
its ability to comply with all laws to which it may be subject;
effect of product recalls or voluntary market withdrawals; the
implementation of its enterprise resource planning system; its
ability to attract and retain qualified personnel; the accuracy of
its accounting estimates and assumptions, including pension plan
obligations and the carrying value of intangible assets; the
ability to obtain regulatory clearance and approval of its products
as well as compliance with any post-approval obligations, including
quality control of its manufacturing; legislative and regulatory
reform; the ability of Alcon Pharmaceuticals Ltd. to comply with
its investment tax incentive agreement with the Swiss State
Secretariat for Economic Affairs in Switzerland and the Canton of
Fribourg, Switzerland; its ability to manage environmental, social
and governance matters to the satisfaction of its many
stakeholders, some of which may have competing interests; its
ability to operate as a stand-alone company; whether the
transitional services Novartis has agreed to provide Alcon are
sufficient; the impact of the spin-off from Novartis on Alcon's
shareholder base; the impact of being listed on two stock
exchanges; the ability to declare and pay dividends; the different
rights afforded to its shareholders as a Swiss corporation compared
to a US corporation; and the effect of maintaining or losing its
foreign private issuer status under US securities laws. Additional
factors are discussed in Alcon’s filings with the United States
Securities and Exchange Commission, including its Form 20-F. Should
one or more of these uncertainties or risks materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those anticipated. Therefore, you should not rely
on any of these forward-looking statements.
Forward-looking statements in this press release speak only as
of the date of its filing, and Alcon assumes no obligation to
update forward-looking statements as a result of new information,
future events or otherwise.
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Investor Relations Allen
Trang + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
investor.relations@alcon.com
Media Relations Blake Overby
+ 1 817 551 4328 (Fort Worth) + 1 682 321 2897 (Fort Worth)
globalmedia.relations@alcon.com
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