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06.08.2018 | Products

Allergan’s RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05% Approved in Canada

-- New Delivery System Will Now Provide RESTASIS® in a Preservative Free, Easy-to-Use, Multi-Dose Bottle --

-- RESTASIS the Only* Health Canada Approved Treatment to Help Patients Produce More of Their Own Tears --

MARKHAM, ONTARIO – Thursday, June 7, 2018 - Allergan plc announced today that it has received approval from Health Canada for RESTASIS MULTIDOSE (Cyclosporine Ophthalmic Emulsion) 0.05%.

RESTASIS MULTIDOSE is a preservative-free, multi-dose bottle offering the same preservative-free formulation of RESTASIS®, in a new, easy-to-use multi-dose bottle. RESTASIS® is the leading^* treatment approved in Canada to treat the signs and symptoms of Dry Eye1-4.

RESTASIS® has helped more than 6.6 Million patients in North America5 since its launch, by increasing the eyes' natural ability to produce tears, which may be reduced by the inflammation associated with Chronic Dry Eye1-4. RESTASIS® starts to reverse the cycle of inflammation when treatment begins, and works to improve ocular surface health and tear quality as treatment continues1-4. RESTASIS® alleviates the feelings of dryness, grittiness, burning and stinging and it helps improve the ability to perform daily activities like driving, reading or using a computer1-4.

"RESTASIS MULTIDOSE will be an important addition to the treatment options available to patients, 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 Dry Eye expert Dr. Bruce Jackson, MD, RCPSC.

RESTASIS MULTIDOSE, the only multi-dose Preservative Free prescription option for the treatment of Dry Eye, 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 provides a convenient solution for patients who prefer multi-dose formats.

The new RESTASIS MULTIDOSE bottle is an advanced delivery system which ensures sterility to prevent contamination4. The bottle is slightly larger and easier to manipulate than the single-use vials for many patients. At Allergan we continuously look for innovation to help our patients wherever possible, to get the best medication to treat their conditions.

"RESTASIS MULTIDOSE exemplifies Allergan's commitment to innovation and customer responsiveness," said Carmen Enciu, Medical Director and Head of the Canadian Chief Medical Office, Allergan Canada. "Through our Open Science model, we strive to deliver advancements to help improve patient care, such as the new multi-dose bottle."

RESTASIS MULTIDOSE will be available in Canada this summer with specific timing to be confirmed.

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.

About RESTASIS

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 Eye1-4.

About Allergan plc

Allergan plc, headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine 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, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan’s success is powered by our 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 .

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 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

*As of June 2nd 2018 ^*Measured by total volume of prescriptions in Canada as of April 2018

CONTACTS: Media:

Liana N. Del Medico
Associate Director, Corporate Communications
Allergan Inc.
T. 905 940 7003

Fiona Buchanan
Argyle Public Relationships
fbuchanan@argylepr.com
T. 416-968-7311

References:

1. Rao SN. Topical cyclosporine 0.05% for the prevention of Dry Eye Disease Progression. J Ocul Pharmacol Ther 2010;26(2):157-163.

2. Rao SN. Reversibility of dry eye deceleration after topical cyclosporine 0.05% withdrawal. J Ocul Pharmacol Ther 2011;00(0):1-7.

3. Stonecipher KG, et al. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye Clin Ophthalmol 2016;10:887-95.

4. Restasis MultiDoseTM Product Monograph, Allergan Inc., June 1, 2018

5. Data on file, Allergan Inc