DUBLIN, Oct. 28, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of RESTASIS since the launch in 2003. RESTASIS® is the one and only prescription treatment FDA approved to help patients with a type of Chronic Dry Eye make more of their own tears.
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RESTASIS® helps increase your eyes' natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye. RESTASIS® did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
'RESTASIS MULTIDOSE™ will be an important addition to the Allergan family of dry eye products, as it will enable healthcare providers to offer an additional option for those patients who may prefer their eye drops in a multi-dose bottle versus single-use vials,' said Neda Shamie, MD, fellowship-trained cornea and cataract specialist, of Advanced Vision Care, of Los Angeles, Calif.
RESTASIS MULTIDOSE™ is designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative. The new multi-dose bottle uses less plastic than a package of single-use vials and will be available for the same price.
'RESTASIS MULTIDOSE™ exemplifies Allergan's commitment to innovation and customer responsiveness,' said David Nicholson, Chief R&D Officer at Allergan. 'Through our Open Science model, we drive to deliver advancements in highly engineered developments, such as the new multi-dose bottle.'
About Chronic Dry Eye
One type of chronic dry eye is caused by reduced tear production due to inflammation. Dry eye is often a chronic disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.
RESTASIS® and RESTASIS MULTIDOSE Ophthalmic Emulsion help increase your eyes' natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye. RESTASIS® and RESTASIS MULTIDOSE did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
Important Safety Information
Do not use RESTASIS® and RESTASIS MULTIDOSE Ophthalmic Emulsion if you are allergic to any of the ingredients. Be careful not to touch the container tip to your eye or other surfaces, to help avoid eye injury and contamination. RESTASIS® and RESTASIS MULTIDOSE should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use of RESTASIS® and RESTASIS MULTIDOSE and may be reinserted after 15 minutes.
The most common side effect is a temporary burning sensation. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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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.
With commercial operations in approximately 100 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 Allergan's website at www.Allergan.com.
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 June 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.
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