6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
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`04.25.2017 | Investors
`
`Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to
`Temporarily Increase Tear Production
`
`First-of-its-Kind Product Further Adds to Allergan's Robust Eye Care Portfolio
`
`DUBLIN, April 25, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN) today announced that it has been granted marketing
`authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first
`and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.
`
`TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production
`of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear
`production completed with 145 aqueous deficient dry eye adult patients. 
`
`"TrueTear™ represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and
`drug-free way to temporarily increase tear production," said David Nicholson, Chief R&D Officer, at Allergan. "As an
`innovator in eye care, we are continually looking for new products to offer through our portfolio, and TrueTear™ represents
`the next step forward."
`
`The new advancement is an addition to Allergan's current eye care portfolio. Last May, Allergan announced positive results
`from two pivotal trials for TrueTear™ that showed an increase in tear production upon nasal neurostimulation in adults
`with aqueous tear deficiency. 
`
`"In clinical trials, TrueTear™ demonstrated increased tear production upon stimulation of the nasal cavity," said John
`Sheppard, M.D., M.M. Sc., professor of Ophthalmology, Eastern Virginia Medical School and president of Virginia Eye
`Consultants. "Interestingly, neurostimulation has been used as an approach for a wide variety of disorders for more than 30
`years. TrueTear™ is the first of its kind to provide a temporary increase in tear production in this way."
`
`About the Studies
`
`This site uses cookies to give you the best possible experience. By browsing our website, you agree to our use of
`Study 1 is a prospective, randomized, controlled, double-masked, multicenter, cross-over trial in which participants used an
`cookies. - Read more
`active device and two control applications. The primary effectiveness endpoint of increased tear production during
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`MYLAN - EXHIBIT 1050
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc. - IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
`intranasal application as measured by Schirmer score compared to both controls was met. Study 2 is a prospective, single-
`arm, multicenter, open-label clinical trial in which participants used TrueTear™ to stimulate tear production for 180
`days. The primary effectiveness endpoint of increased tear production as measured by Schirmer score during application of
`the device compared with basal Schirmer score at Day 180 was met.  Secondary endpoints of increased tear production as
`measured by Schirmer score during application of the device compared with basal Schirmer score at Days 0, 7, 30 and 90
`were also met. The direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye
`disease was not assessed as part of these clinical trials.  All device-related adverse events were mild in nature. There were
`no device-related serious adverse events.
`
`ABOUT TRUETEAR
`
`INDICATION
`TrueTear™ provides a temporary increase in tear production during neurostimulation in adult patients.
`
`IMPORTANT SAFETY INFORMATION
`CONTRAINDICATIONS
`Do not prescribe TrueTear™ to patients with a cardiac pacemaker, implanted or wearable defibrillator, or other implanted
`metallic or electronic device within head or neck; a known hypersensitivity to the hydrogel device material; or chronic or
`recurrent nosebleeds, or bleeding disorder/condition that can lead to increased bleeding.
`
`WARNINGS
`Do not apply stimulation around electronic monitoring equipment (eg, cardiac monitors, ECG alarms), in the bath/shower,
`while driving, operating machinery, during activity in which sneezing/watery eyes may cause risk, areas other than the
`nose, within 3 feet of shortwave or microwave therapy equipment, around flammable anesthetics mixture (air, oxygen or
`nitrous oxygen). Persistent use on irritated nasal tissue may cause injury. Safety/effectiveness not established for longer
`than 6 months or for treating aqueous-deficient dry eye disease. Safety not established in pregnancy, patients under 22
`years of age, patients with nasal or sinus surgery (including nasal cautery) or significant trauma; severe nasal airway
`obstruction or vascularized polyp; active, severe systemic or chronic seasonal allergies; rhinitis or sinusitis requiring
`treatment; untreated nasal infection; and disabling arthritis, neuropathy, severe dexterity impairment or limited motor
`coordination.
`
`PRECAUTIONS
`Consult patients to discontinue use if pain, discomfort or numbness in the nose persists after adjusting for high levels/long
`sessions; to remove studs, nose rings, or other nose jewelry before use; to not use prescription eye medications or nasal
`sprays 30 minutes before or after using TrueTear™. Suspected or diagnosed heart disease patients should follow doctor's
`precautions.  Keep away from children.
`
`ADVERSE EVENTS
`Nasal pain, discomfort or burning (10.3%); transient electrical discomfort (5.2%); nosebleed (5.2%); nasal congestion
`(3.1%); headaches (2.1%); trace blood, dot heme in nostril (2.1%); facial pain (2.1%); sore eye (1.0%); sinus pain (1.0%);
`periorbital pain (1.0%); runny nose (1.0%); nasal ulcers (1.0%); and light-headedness (1.0%).
`
`Caution: Federal law restricts this device to sale by or on the order of a licensed physician. For the full Directions for Use,
`please call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.
`
`About Allergan plc 
`
`Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new
`industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded
`pharmaceuticals, devices and biologic products for patients around the world.
`
`Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical
`aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
`
`Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and
`developing game-changing ideas and innovation for better patient care.  This approach has led to Allergan building one of
`the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in
`development.
`
`Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. 
`Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by
`always doing what is right.
`This site uses cookies to give you the best possible experience. By browsing our website, you agree to our use of
`With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare
`cookies. - Read more
`providers and patients to deliver innovative and meaningful treatments that help people around the world live longer,
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
`healthier lives every day.
`
`For more information, visit Allergan's website at www.Allergan.com.
`
`Forward-Looking Statement
`
`Statements contained in this press release that refer to future events or other non-historical facts are forward-looking
`statements that reflect Allergan's current perspective of existing trends and information as of the date of this release.
`Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking
`statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors
`affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of
`FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued
`demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in
`Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's
`Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter
`ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as
`expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
`
`CONTACTS: 
` 
` 
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` 
` 
` 
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` 
`
`Investors:
`Karina Calzadilla        
`(862) 261­7328
` 
`Media:
`Mark Marmur
`(973) 906­1526
` 
`Suzanne Jacobson
`(201) 273­4724
`
` 
`
`To view the original version on PR Newswire, visit:ttp://www.prnewswire.com/news...
`
`SOURCE Allergan plc
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
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`This site uses cookies to give you the best possible experience. By browsing our website, you agree to our use of
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
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`6/26/2017 Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Produ…
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