Poised for Significant Growth in
Prescription Dry Eye Segment
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye
health company dedicated to helping people see better to live
better, today announced it has completed its acquisition of XIIDRA
(lifitegrast ophthalmic solution) 5%, a non-steroid eye drop
specifically approved to treat the signs and symptoms of dry eye
disease (DED) focusing on inflammation associated with dry eye, and
certain other ophthalmology assets.
In addition to XIIDRA, Bausch + Lomb’s dry eye offering includes
eye and contact lens drops from the company’s consumer brand
franchises and its pharmaceutical business, including MIEBO™
(perfluorohexyloctane ophthalmic solution), which launched in the
United States earlier this month as the first and only FDA-approved
prescription eye drop for DED that directly targets tear
evaporation.
“We expect to quickly take a leading position in the growing
prescription dry eye category with the XIIDRA acquisition and MIEBO
launch and, importantly, help the millions of patients not
currently receiving adequate treatment for dry eye disease,” said
Brent Saunders, chairman and CEO, Bausch + Lomb.
DED affects approximately 739 million people worldwide,
including approximately 38 million people in the United States.1
The prescription U.S. DED field is expected to grow at a
double-digit compounded annual growth rate over the next five
years.2
As part of the transaction, Bausch + Lomb also acquired
libvatrep (also known as SAF312), an investigational compound being
studied for the treatment of chronic ocular surface pain, and
AcuStream™ technology, an investigational device that may have the
potential to facilitate precise dosing and accurate delivery of
certain topical ophthalmic medications to the eye.3,4 Libvatrep is
currently in Phase 2b development with study results anticipated to
be completed in the second half of 2023.
Transaction Details Under the terms of the agreement,
Bausch + Lomb, through an affiliate, acquired XIIDRA and the other
ophthalmology assets from Novartis for up to $2.5 billion,
including an upfront payment of $1.75 billion in cash with
potential milestone obligations of up to $750 million based on
sales thresholds and pipeline commercialization. Bausch + Lomb also
brought on the sales force supporting XIIDRA. The company funded
the acquisition with the previously announced offering of $1.4
billion aggregate principal amount of 8.375% senior secured notes
due 2028 (“Notes”) and $500 million of new term B loans under an
incremental term loan facility (“Term Loan Facility”). The issuance
of the Notes and the closing of the Term Loan Facility occurred
substantially concurrently with the closing of the acquisition.
WHAT IS XIIDRA? XIIDRA (lifitegrast ophthalmic solution)
5% is a prescription eye drop used to treat the signs and symptoms
of dry eye disease.
IMPORTANT SAFETY INFORMATION Do not use XIIDRA if you are
allergic to any of its ingredients. Seek medical care immediately
if you get any symptoms of an allergic reaction.
The most common side effects of XIIDRA include eye irritation,
discomfort or blurred vision when the drops are applied to the
eyes, and an unusual taste sensation.
To help avoid eye injury or contamination of the solution, do
not touch the container tip to your eye or any surface. If you wear
contact lenses, remove them before using XIIDRA and wait for at
least 15 minutes before placing them back in your eyes.
It is not known if XIIDRA is safe and effective in children
under 17 years of age.
Click here for full Prescribing Information for
XIIDRA.
WHAT IS MIEBO? MIEBO™ (perfluorohexyloctane ophthalmic
solution) is used to treat the signs and symptoms of dry eye
disease.
IMPORTANT SAFETY INFORMATION
- Patients should remove contact lenses before using MIEBO and
wait for at least 30 minutes before reinserting.
- It is important for patients to use MIEBO exactly as
prescribed.
- It is not known if MIEBO is safe and effective in children
under the age of 18.
- The most common eye side effect seen in studies was blurred
vision (1% to 3% of patients reported blurred vision and eye
redness).
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Click here for full Prescribing Information for
MIEBO.
About Bausch + Lomb Bausch + Lomb is dedicated to
protecting and enhancing the gift of sight for millions of people
around the world – from the moment of birth through every phase of
life. Its comprehensive portfolio of more than 400 products
includes contact lenses, lens care products, eye care products,
ophthalmic pharmaceuticals, over-the-counter products and
ophthalmic surgical devices and instruments. Founded in 1853,
Bausch + Lomb has a significant global research and development,
manufacturing and commercial footprint with approximately 13,000
employees and a presence in nearly 100 countries. Bausch + Lomb is
headquartered in Vaughan, Ontario with corporate offices in
Bridgewater, New Jersey. For more information, visit www.bausch.com
and connect with us on Twitter, LinkedIn, Facebook and
Instagram.
Bausch + Lomb Forward-looking Statements This news
release may contain forward-looking statements, including, but not
limited to, the anticipated impact of the transaction, including
our anticipated stake in the dry eye field. Forward-looking
statements may generally be identified by the use of the words
“anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,”
“could,” “would,” “will,” “may,” “believes,” “estimates,”
“potential,” “target,” or “continue” and variations or similar
expressions. These statements are based upon the current
expectations and beliefs of management and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include, but are not limited to, the
risks and uncertainties discussed in Bausch + Lomb’s filings with
the U.S. Securities and Exchange Commission and the Canadian
Securities Administrators (including its Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2023, and its Annual
Report on Form 10-K for the fiscal year ended Dec. 31, 2022), which
factors are incorporated herein by reference. In addition, such
risks and uncertainties include, but are not limited to, the
following: the effect of the announcement or closing of the
Transaction on the market price of Bausch + Lomb’s common stock and
Bausch + Lomb’s ability to maintain relationships with customers,
suppliers, other business partners or governmental entities; the
impact of the Transaction on Bausch + Lomb’s business, financial
position and results of operations, including with respect to
expectations regarding margin expansion, accretion and
deleveraging; the possibility that the expected benefits of the
Transaction will not be realized or will not be realized within the
expected time period; and risks relating to potential diversion of
management attention away from Bausch + Lomb’s ongoing business
operations. Readers are cautioned not to place undue reliance on
any of these forward-looking statements. These forward-looking
statements speak only as of the date hereof. Bausch + Lomb
undertakes no obligation to update any of these forward-looking
statements to reflect events or circumstances after the date of
this news release or to reflect actual outcomes, unless required by
law.
References
- Downs P. 2020 Dry Eye Products Market Report: A Global Analysis
for 2019 to 2025. Market Scope; 2020.
- U.S. dry-eye size including aqueous supplements, secretagogues,
corticosteroids, LFA-1 antagonists, calcineurin inhibitors across
anti-inflammatory and non-anti-inflammatory drug classes. Source:
DRG (12/2022); Expert interviews; Analyst reports.
- Quiroz-Mercado H, Ivri E, Gonzalez-Salinas R, et al. Clinical
evaluation of a novel electromechanical topical ocular drug
delivery system: two phase 1 proof of concept studies. Clin
Ophthalmol. 2020;14:139-147.
- Data on file. AcuStream repetitive acute and real-time delivery
study. Novartis, 2022.
© 2023 Bausch + Lomb.
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version on businesswire.com: https://www.businesswire.com/news/home/20230928609662/en/
Media: T.J. Crawford tj.crawford@bausch.com (908)
705-2851
Lainie Keller lainie.keller@bausch.com (908) 927-1198
Investor: George Gadkowski george.gadkowski@bausch.com
(877) 354-3705 (toll free) (908) 927-0735
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