AGN Allergan plc

DUBLIN, Sept. 19, 2017 /PRNewswire/ -- For over 17 years, the highly-coveted Allure Best of Beauty Breakthrough Awards have recognized hair, makeup and skin products, fragrances and devices  for their innovative formulations, performance and technologies.  Today Allergan plc (NYSE: AGN) is happy to announce that Allure has awarded the 2017 Best of Beauty Breakthrough Award to three of the company's products: JUVÉDERM VOLBELLA^® XC, RHOFADE^® (oxymetazoline HCl) cream 1%, and SkinMedica^® Lytera 2.0 Pigment Correcting Serum.

"As a company, Allergan is committed to innovation and developing products that meet evolving patient needs, which is why we continue to be a leader in the aesthetic and medical dermatology categories," said Bill Meury, Chief Commercial Officer at Allergan,  "We are proud and grateful that Allure has recognized this commitment with their prestigious Beauty Breakthrough Award."

JUVÉDERM VOLBELLA^® XC was honored marking the second Allure Beauty Breakthrough award for the JUVÉDERM^® collection of fillers (JUVÉDERM VOLUMA^® XC won in 2014). Both products feature Allergans proprietary VYCROSS^® technology.This second win for the collection emphasizes the brand's position as the dermal filler category leader and recognizes the technology's tailored gel properties and specialized filler product offerings for specific treatment areas. JUVÉDERM VOLBELLA^® XC adds subtle volume to lips and softens the appearance of vertical lip lines in adults over the age of 21.^1-4

A 2017 addition to Allergan's Medical Dermatology portfolio, RHOFADE^® cream was also named an Allure Beauty Breakthrough Award winner. RHOFADE^® cream is a prescription medicine used on the skin to treat ongoing facial redness due to rosacea in adults.⁵ Since FDA approval in January, the brand has made great strides in educating media and consumers about ongoing facial redness due to rosacea.

Finally, Allure named SkinMedica^® Lytera^® 2.0 Pigment Correcting Serum a breakthrough product, which marks the fifth time SkinMedica^® has won an Allure Beauty Award, and the second time the brand has earned the publication's breakthrough accolade. This is also the fourth editorial award for Lytera^® 2.0 since launch, adding to the nine wins collected by the product's predecessor, Lytera^® Skin Brightening Complex. SkinMedica^® Lytera^® 2.0 Pigment Correcting Serum is an advanced pigment-correcting serum with an innovative formula that is retinol and hydroquinone free that reduces the appearance of existing skin discoloration and supports  the skin's ability to resist intrinsic and extrinsic factors that can cause reoccurring and future discoloration.

The 2017 Beauty Breakthrough Award winners will be announced in the October issue of Allure.

JUVÉDERM VOLUMA^® XC and JUVÉDERM VOLBELLA^® XC Important Information

APPROVED USES

JUVÉDERM VOLUMA^® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21.

JUVÉDERM VOLBELLA^®  XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive JUVÉDERM VOLUMA^®  XC or JUVÉDERM VOLBELLA^® XC injectable gels?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins used in these products.

What precautions should my doctor advise me about?

• Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
• The safety of JUVÉDERM VOLUMA^® XC in patients under 35 years or over 65 years, and the safety of JUVÉDERM VOLBELLA^® XC in patients under 22 years has not been studied
• The safety and effectiveness of JUVÉDERM VOLUMA^® XC in areas other than the cheek area, and JUVÉDERM VOLBELLA^® XC in areas other than the lips and perioral area have not been established in controlled clinical studies
• Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
• Patients who experience skin injury near the site of injection with these products may be at higher risk for side effects
• Tell your doctor if you are on immunosuppressive therapy used to decrease the body's immune response, as use of these products may result in an increased risk of infection
• Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

What are possible side effects?

The most common side effects included swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching. With JUVÉDERM VOLUMA^® XC, most side effects were moderate (uncomfortable) and lasted 2 to 4 weeks.  For JUVÉDERM VOLBELLA^® XC, most side effects were mild or moderate and lasted 30 days or less.

One of the risks with using these products is unintentional injection into a blood vessel, and, while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.

As with all skin injection procedures, there is a risk of infection.

To report a side effect with JUVÉDERM VOLUMA^® XC or JUVÉDERM VOLBELLA^® XC, or for product information, please call Allergan at 1-800-433-8871. Please also visit Juvederm.com for more information.

Available by prescription only.

RHOFADE^® (oxymetazoline HCl) cream 1% Important Safety Information

Indication
RHOFADE^® (oxymetazoline HCl) cream 1% is a prescription medicine used on the skin to treat ongoing facial redness due to rosacea in adults.

Important Safety Information

Before you use RHOFADE^® cream, tell your doctor about all your medical conditions, including if you have: heart, blood vessel, or blood pressure problems, or narrow-angle glaucoma (get medical help if these conditions worsen); problems with blood circulation or have had a stroke; Sjögren's syndrome; scleroderma; Raynaud's phenomenon; thromboangiitis obliterans; or irritated skin or open sores on the face.

Tell your doctor about your medications, as use with RHOFADE^® cream may cause serious side effects.

The most common side effects at the application site include: skin reactions, worsening of rosacea pimples, itching, redness, and pain.

You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Product Information for RHOFADE^® cream.

SkinMedica^®

The SkinMedica® product described here is intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. This SkinMedica® product is not intended to be a drug product that diagnoses, treats, cures or prevents any disease or condition. This product has not been approved by the FDA and the statements on these pages have not been evaluated by the FDA.

References:

^1. Data on File, Allergan; Proforma Sales JUVÉDERM VOLUMA^® XC, 2015.
^2. Bernardin A et al. VYCROSS^®: An innovative dermal filler technology. Poster presented at: 1st Annual Anti-Aging Medicine European Congress (AMEC); October 11-12, 2013; Paris, France.
^3. JUVÉDERM VOLBELLA^® XC Patient Labeling, 2016.
^4. JUVÉDERM VOLUMA^® XC Patient Labeling, 2016.
^5. RHOFADE^® Prescribing Information, 2017.

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 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 with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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 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; 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 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

© 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners.

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SOURCE Allergan plc