"Allergan plc NYSE AGN httpstudio.financialcontent.comprnewsPageQuoteTickerAGN 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 FDAcleared 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  aqueous deficient dry eye adult patients.  TrueTear represents a technological breakthrough for eye care professionals as it delivers an effective noninvasive and drugfree way to temporarily increase tear production said David Nicholson Chief RD 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 Allergans 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  years. TrueTear is the first of its kind to provide a temporary increase in tear production in this way. About the Studies Study  is a prospective randomized controlled doublemasked multicenter crossover trial in which participants used an active device and two control applications. The primary effectiveness endpoint of increased tear production during intranasal application as measured by Schirmer score compared to both controls was met. Study  is a prospective singlearm multicenter openlabel clinical trial in which participants used TrueTear to stimulate tear production for  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  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    and  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 devicerelated adverse events were mild in nature. There were no devicerelated 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 disordercondition that can lead to increased bleeding. WARNINGS  Do not apply stimulation around electronic monitoring equipment eg cardiac monitors ECG alarms in the bathshower while driving operating machinery during activity in which sneezingwatery eyes may cause risk areas other than the nose within  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. Safetyeffectiveness not established for longer than  months or for treating aqueousdeficient dry eye disease. Safety not established in pregnancy patients under  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 levelslong sessions to remove studs nose rings or other nose jewelry before use to not use prescription eye medications or nasal sprays  minutes before or after using TrueTear. Suspected or diagnosed heart disease patients should follow doctors precautions.  Keep away from children. ADVERSE EVENTS  Nasal pain discomfort or burning . transient electrical discomfort . nosebleed . nasal congestion . headaches . trace blood dot heme in nostril . facial pain . sore eye . sinus pain . periorbital pain . runny nose . nasal ulcers . and lightheadedness .. 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 . Please call  to report an adverse event. About Allergan plc   Allergan plc NYSE AGN httpstudio.financialcontent.comprnewsPageQuoteTickerAGN 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 bestinclass products for the central nervous system eye care medical aesthetics and dermatology gastroenterology womens health urology and antiinfective therapeutic categories. Allergan is an industry leader in Open Science the Companys RD model which defines our approach to identifying and developing gamechanging 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  midtolate stage pipeline programs in development.  Our Companys success is powered by our more than  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. With commercial operations in approximately  countries Allergan is committed to working with physicians healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer healthier lives every day. For more information visit Allergans website at  http  ForwardLooking Statement  Statements contained in this press release that refer to future events or other nonhistorical facts are forwardlooking statements that reflect Allergans 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 forwardlooking statements. Actual results may differ materially from Allergans current expectations depending upon a number of factors affecting Allergans 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 Allergans products difficulties or delays in manufacturing and other risks and uncertainties detailed in Allergans periodic public filings with the Securities and Exchange Commission including but not limited to Allergans Annual Report on Form K for the year ended December   and Quarterly Report on Form Q for the quarter ended September   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 forwardlooking statements.  CONTACTS  Investors   Karina Calzadilla                   Media    Mark Marmur          Suzanne Jacobson      SOURCE Allergan plc Related Links http"