8/16/22, 11:21 AM
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`Bausch+ Lomb Receives FDA Approval of LUMIFY™ - The Only Over-The-Counter Eye Drop With Low-Dose Brimonidine For T ...
`
`BAUSCH- Health
`
`Bausch+ Lomb Receives FDA Approval of
`LUMIFY™ - The Only Over-The-Counter Eye Drop
`With Low-Dose Brimonidine For The Treatment
`Of Eye Redness
`
`December 22, 2017
`
`Clinical Studies Showed 95% Symptom Improvement At One Minute, And Reduced
`Redness For Up To Eight Hours
`
`LAVAL, Quebec, Dec. 22, 2017 / PRNewswire/ -- Bausch + Lomb, a leading global eye health
`company and wholly owned subsidiary of Valeant Pharmaceutica ls International, Inc. ( NYSE:
`VRX and TSX: VRX) ( "Va leant"), today announced that the U.S. Food and Drug Administration
`(FDA) has approved LUMIFY™ (brimonidine tartrate ophthalmic solution 0.025%) as the first
`and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate for the
`treatment of ocular redness. Bri monidine, which was first approved by the FDA in 1996 for
`intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in
`prescription eye care products.
`
`"With today's approval of LUMIFY, consumers have a new and unique treatment option to
`relieve red, irritated eyes," said Joseph C. Papa, chairman and CEO of Va leant. "LUMIFY is the
`fi rst and only OTC eye drop with low-dose brimonidine, which has been clinically proven to be
`safe and effective since its initial approval as a prescription medication in 1996. We expect
`LUMIFY wi ll be available for purchase in major reta ilers in the second quarter of 2018."
`
`Ocular redness is a common condition that can be ca used by inflammation of almost any part
`of the eye. With frequent use, non selective redness re lieving eye drops that constrict blood
`vessels in the eye can result in users developing a tolerance or loss of effectiveness, as well as
`rebound redness. In contrast, low dose brimonidine, the active ingredient in LUMIFY, selectively
`constricts veins in the eye, increasing the availability of oxygen to surrounding tissue, thereby
`reducing the potential risk of these side effects.
`
`"Patients with eye redness and irritation can experience negative social connotations, which
`may impact daily life," said Dr. Paul Karpecki, OD, FAAO, Director of Corneal Services at
`Kentucky Eye I nstitute. "Having a drop that reduces redness without the side effects of
`rebound hyperem ia or tachyphylaxis, which may lead to overuse and potential cornea l toxicity,
`is a very exciting option that I look forward to recommending to my patients."
`
`For more information, please visit
`www.bausch.com
`
`https://ir.bauschhealth.com/news-releases/2017 /12-22-2017-200318686
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`1/3
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`Eye Therapies Exhibit 2104, 1 of 3
`Slayback v. Eye Therapies - IPR2022-00142
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`Bausch + Lomb Receives FDA Approval of LUMIFY™ - The Only Over-The-Counter Eye Drop With Low-Dose Brimonidine For T…
`8/16/22, 11:21 AM
`The brimonidine tartrate ophthalmic solution 0.025% product was licensed by Eye Therapies,
`Inc. to Bausch + Lomb.
`
`About Bausch + Lomb
`Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye
`health organization that is solely focused on protecting, enhancing and restoring people's
`eyesight. Its core businesses include over-the-counter supplements, eye care products,
`ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices
`and instruments. Bausch + Lomb develops, manufactures and markets one of the most
`comprehensive product portfolios in our industry, which is available in more than 100 countries.
`
`About Valeant
`Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty
`pharmaceutical company that develops, manufactures and markets a broad range of
`pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye
`health, neurology and branded generics. More information about Valeant can be found at
`www.valeant.com
`
`. F
`
`orward-looking Statements
`This news release may contain forward-looking statements which may generally be identified
`by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would,"
`"may," "will," "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, risks and uncertainties discussed in the Company's
`most recent annual or quarterly report and detailed from time to time in Valeant's other filings
`with the Securities and Exchange Commission and the Canadian Securities Administrators,
`which factors are incorporated herein by reference. 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. Valeant 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.
`
`LUMIFY is a trademark of Bausch & Lomb Incorporated or its affiliates.
`© 2017 Bausch & Lomb Incorporated.
`
`LUM.0020.USA.17
`
`Investor Contact:
`
`Arthur Shannon
`
`Media Contact:
`
`Lainie Keller
`
`arthur.shannon@valeant.com
`
`lainie.keller@valeant.com
`
`(514) 856-3855
`
`(908) 927-0617
`
`https://ir.bauschhealth.com/news-releases/2017/12-22-2017-200318686
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`2/3
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`Eye Therapies Exhibit 2104, 2 of 3
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`Bausch + Lomb Receives FDA Approval of LUMIFY™ - The Only Over-The-Counter Eye Drop With Low-Dose Brimonidine For T…
`8/16/22, 11:21 AM
`(877) 281-6642 (toll free)
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`-only-over-the-counter-eye-drop-with-low-dose-brimonidine-for-the-treatment-of-eye-redness-
`300575106.html
`
`SOURCE Valeant Pharmaceuticals International, Inc.; Bausch + Lomb
`
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`IR and Communications Contacts
`General Investor Relations
`Email: ir@bauschhealth.com
`877-281-6642
`514-856-3855 (Canada)
`
`Media inquiries
`Kevin Wiggins
`Email:
`Corporate.communications@bauschhealth.com
`Ofce: 908-541-3785
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`t h e L e g a l N o t i c e a n d P r i v a c y P o l i c y .
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`Eye Therapies Exhibit 2104, 3 of 3
`Slayback v. Eye Therapies - IPR2022-00142
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