- Expands Alcon’s leading surgical portfolio and leverages the
company’s commercial execution expertise
- Strong safety and efficacy profile evidenced by five-year
study on Hydrus Microstent, a minimally invasive glaucoma surgery
(MIGS) device
- Indicated to lower intraocular pressure for open-angle
glaucoma patients in connection with cataract surgery*, Hydrus
Microstent is part of a large surgical glaucoma market with a
growing patient population
Ad hoc announcement pursuant to Art. 53 LR
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, today announced its intention to
acquire Ivantis®, developer and manufacturer of the novel Hydrus®
Microstent, a minimally-invasive glaucoma surgery (MIGS) device
designed to lower intraocular pressure for open-angle glaucoma
patients in connection with cataract surgery*. The intended
acquisition affirms Alcon’s commitment to the surgical glaucoma
space, further strengthening its industry-leading portfolio across
cataract, refractive, retina and glaucoma.
The five-year HORIZON clinical study of Hydrus Microstent is the
longest, continuous follow-up of a MIGS device. It demonstrated
that 65% of Hydrus Microstent patients remained medication-free at
five years post-implant. The results also showed over 60% reduction
in risk of invasive secondary glaucoma surgeries compared to
cataract surgery alone – and its safety profile was sustained
through the five-year follow up.1 Among MIGS rated in the 2020
American Academy of Ophthalmology Primary Open-Angle Glaucoma
Preferred Practice Pattern (PPP), the Hydrus Microstent received
the highest grade for quality body of evidence and a strong
recommendation.2
“Glaucoma is the second-largest cause of blindness after
cataracts, impacting more than 75 million people globally, with
significant unmet patient need. This transaction will allow us to
add a uniquely effective product into our glaucoma portfolio around
the world," said David Endicott, CEO of Alcon. "Our global
commercial footprint and development capabilities make us well
positioned to build on the success of Ivantis and help even more
patients see brilliantly with Hydrus Microstent.”
“With more than 85,000 Hydrus devices implanted, now is the time
to expand access globally, and Alcon is the right partner as the
global leader in eye care,” said Dave Van Meter, President and CEO
of Ivantis. “We started this with a mission to bring unprecedented
scientific rigor to the MIGS space, and we are gratified and
humbled by the rapid adoption of Hydrus since our launch in late
2018. Thanks to the relentless, unwavering commitment of Ivantis
employees and our investors, we now have the opportunity to bring
the clinically proven Hydrus technology to more glaucoma patients
worldwide.”
Hydrus Microstent was approved by the FDA in August 2018 for use
in conjunction with cataract surgery in the United States. In the
UK, Canada, Australia, Singapore, and Germany, the MIGS device is
indicated for primary open-angle glaucoma in conjunction with
cataract surgery or as a stand-alone procedure.
Alcon will pay $475 million in upfront consideration to acquire
Ivantis, Inc. Alcon may be required to make additional contingent
payments upon the achievement of certain regulatory and commercial
milestones. The transaction is anticipated to close in the first
quarter of 2022 subject to customary closing conditions, including
regulatory approval.
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.
About Ivantis
Ivantis Inc. is a privately-held company established in 2007 to
design, develop and commercialize new technologies to treat eye
disease. Investors include New Enterprise Associates, Delphi
Ventures, Foresite Capital, RA Capital Management, Ascension
Ventures, EDBI, GBS Ventures, MemorialCare Innovation Fund, Merieux
Development and Vertex Healthcare. The company is headquartered in
Irvine, California. Ivantis, Hydrus and Tri-Modal are registered
trademarks of Ivantis Inc. All rights reserved 2020.
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.
References
- Ahmed, I.K. (2021, Mar. 4-7). 5 Year Follow Up from the HORIZON
Trial. American Glaucoma Society Virtual Annual Meeting.
- Primary Open-Angle Glaucoma Preferred Practice Pattern®. Gedde,
Steven J. et al. Ophthalmology 2020;128(1): 71-150.
*Currently approved for standalone use and commercialized in the
UK, 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 Karen
King Allen Trang + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort
Worth) investor.relations@alcon.com
Media Relations Blake Overby
+ 41 589 112 111 (Geneva) + 1 817 551 8057 (Fort Worth)
globalmedia.relations@alcon.com
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