Innovative Technology Offers a Drug-Free & Drop-Free Option for Patients Suffering from Inadequate Tear Production
DUBLIN, April 13, 2018 /PRNewswire/ — Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced the official launch of TrueTear®, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.
TrueTear®, a handheld neurostimulation device with disposable tips that is inserted into the nasal cavity to induce the production of natural tears, is a novel and innovative approach for those patients with inadequate tear production. In two clinical trials, TrueTear® was shown to be safe and effective for temporarily increasing tear production in adult patients.
The neurostimulation device will be officially launched during the 2018 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators annual meetings being held April 13-17 in Washington, DC.
"TrueTear® is the latest in a long line of innovations that have helped make Allergan a leading global eye care company. We are excited to add this drug-free, drop-free treatment option for adult patients with inadequate tear production to our current portfolio. This milestone truly represents our company's ongoing commitment to developing eye care products that help improve the lives of patients," said Jag Dosanjh, Senior Vice President, US Eye Care. "For more than 70 years, Allergan has remained focused on delivering the most innovative eye care products in the industry. TrueTear®continues the proud heritage of our foundational philosophy: to bring innovative treatments to patients around the world."
"As seen in clinical trials and in my own post-approval experience treating patients, TrueTear® provides tiny pulses of energy within the nasal cavity to create tears and may be appropriate for most patients with inadequate tear production," said John Sheppard, M.D., M.M. Sc., F.A.C.S., Professor of Ophthalmology, Eastern Virginia Medical Schooland President of Virginia Eye Consultants in Norfolk, Virginia. "TrueTear® is the first device of its kind, providing a temporary increase in tear production with neurostimulation, thereby returning the ocular surface to a more normal physiologic state without prescribing drops or surgery."
Allergan: 70 Years Advancing Eye Care
As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry over the last 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion. Our eye care pipeline includes 13 additional agents for multiple ocular conditions.
Our commitment to the well-being of patients is also reflected in philanthropy. Allergan and The Allergan Foundation support more than 150 organizations around the world working to improve lives and communities. We remain steadfast in helping eye care providers deliver the best in patient care through innovative products and outreach programs.
The TrueTear® device is a prescription-only device. Adult patients with dry eye should consult with their eye care professional about TrueTear®.
TrueTear® Important Information
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 visit www.allergan.com/truetear/usa.htm or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.
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 on existing trends and information as of the date of this release. 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; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; 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, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Daphne Karydas
(862) 261-8006
Media:
Amy Rose
(862) 261-7001
Lisa Kim
(714) 246-3843
SOURCE Allergan plc
