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Biopharmaceuticals Ophthalmology Product Launch

 News Release - March 22, 2017

Allergan Announces Availability of RESTASIS MULTIDOSE(TM) (Cyclosporine Ophthalmic Emulsion) 0.05% -- the First FDA-Approved Preservative Free Prescription Eye Drop Available in a Multidose Bottle

DUBLIN, March 22, 2017 -- (Healthcare Sales & Marketing Network) -- Allergan plc (AGN) today announced the availability of RESTASIS MULTIDOSE™, which is the same preservative-free RESTASIS® formulation, but now offered in a multidose bottle. RESTASIS® is the first and only prescription medication FDA-approved to help patients with a type of Chronic Dry Eye make more of their own tears. RESTASIS MultiDose™ is the first and only FDA-approved preservative-free, prescription eye drop in the U.S. to be available in a multidose bottle. RESTASIS® was accessible only in single-use vials, since its launch in 2003 until now.

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.

"Since RESTASIS MultiDose™ is the only FDA-approved preservative-free prescription eye drop in the U.S. to be offered in a multidose bottle, patients now have a choice of a multidose bottle or single-use vials," said Neda Shamie, MD, of Advanced Vision Care, in Los Angeles, Calif.

RESTASIS MULTIDOSE™ is designed with a patented unidirectional valve and air filter technology. The new multi-dose bottle uses less plastic than a package of single-use vials and will be available for the same price.

"We are continuously looking to improve patient care through state-of-the-art product engineering, and RESTASIS MULTIDOSE™ reflects that commitment," said David Nicholson, Chief R&D Officer at Allergan. "This new multi-dose bottle is designed to maintain the preservative-free formulation."

Allergan offers eligible RESTASIS MultiDose™ patients a savings program called My Tears, My Rewards® which helps patients save on each prescription. For more information on the savings program and to determine eligibility, visit www.Restasis.com/savings or call 844-4MY-TEARS.

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 Eye. RESTASIS® and RESTASIS MULTIDOSE™ did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.

About RESTASIS MULTIDOSE™

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.

Indications and Usage

RESTASIS® and RESTASIS MULTIDOSE™ ophthalmic emulsion are indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Important Safety Information

Contraindications

RESTASIS® and RESTASIS MULTIDOSE™ are contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

Warnings and Precautions

Potential for Eye Injury and Contamination: Be careful not to touch the container tip to your eye or other surfaces to avoid potential for eye injury and contamination.

Use With Contact Lenses: RESTASIS® and RESTASIS MULTIDOSE™ should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS® and RESTASIS MULTIDOSE™ ophthalmic emulsion.

Adverse Reactions

In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion 0.05% was ocular burning (upon instillation)—17%. Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

For Restasis® and Restasis Multidose™ full prescribing information, visit www.allergan.com/assets/pdf/restasis_pi and https://www.allergan.com/assets/pdf/restasis-multidose_pi.

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.

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, 2016. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.


Source: Allergan

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