Allergan plc (NYSE: AGN) presented the results of its HARMONY study at the American Society of Dermatologic Surgery Meeting in Chicago this past weekend. Dr. Susan Weinkle, past president of ASDS, presented a paper titled ‘Substantial Improvements in Subject-Assessed Satisfaction with Appearance and Psychological Impact from Combined Facial Aesthetic Treatment with OnabotulinumtoxinA, Dermal Fillers, and Bimatoprost: Primary Results from the “HARMONY” Study’ at an open session on Saturday, October 17.
A majority of patients entering an aesthetic practice have aesthetic concerns covering more than one area of the face, yet the pan-facial approach to treatment has only recently become incorporated into clinical practice. The HARMONY study endeavored to assess the overall impact and psychological benefits of multimodal injectable and topical treatment for facial aesthetics.
The study included 100 subjects (96 female) treated with onabotulinumtoxinA for moderate to severe glabellar lines (n=95) and crow’s feet lines (n=96); hyaluronic acid dermal fillers (n=100) for the correction of age-related mid-face volume deficit and/or moderate to severe facial wrinkles and folds; and received bimatoprost ophthalmic solution 0.03% for eyelash hypotrichosis (n=100). A total of 93 subjects completed the four month study.
Patients were administered the validated FACE-Q “Satisfaction with Face Overall” patient-reported outcome scale prior to treatment and at month four. This scale asked patients about their attitudes to their facial appearance. Additional FACE-Q modules assessed changes in Social Confidence, Psychological Well-Being as well as how old patients felt they looked both before and after treatment.
Study entry scores indicated that subjects were on average somewhat dissatisfied, or somewhat satisfied with aspects of their facial appearance based on the FACE-Q Satisfaction with Facial Appearance Overall scale. After receiving comprehensive pan-facial treatment, on average subjects reported being either very satisfied or somewhat satisfied with their facial appearance.
Secondary FACE-Q endpoints of Age Appraisal, Social Confidence and Psychological Well-Being scores showed highly positive benefits of treatment. Additionally, subjects reported looking an average of 4.3 years younger at the month 4 time point. Common treatment site reactions to fillers included bruising, tenderness, swelling, and lumps. One treatment-related adverse event was reported with onabotulinumtoxinA (eyelid ptosis), and 5 were reported in 4 subjects with bimatoprost ophthalmic solution 0.03% (1 subject discontinued due to the adverse event). All observed adverse events were reported and were consistent with those reported in previous clinical studies. No serious adverse events were reported.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
The dose of BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines or both at the same time.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
Important Safety Information
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes gradually return to previous appearance. To report a side effect, please call Allergan at 1-800-433-8871.
Please see LATISSE® full Product Information.
JUVEDERM® XC AND JUVEDERM VOLUMA® XC Important Information
JUVEDERM® XC injectable gel is for injection into the facial tissue to temporarily add volume to the skin for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
JUVEDERM 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.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVEDERM® injectable gel formulation?
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 the gram-positive bacterial proteins or lidocaine 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 JUVEDERM ® XC injectable gels in patients under 18 years, and the safety of JUVEDERM VOLUMA® XC in patients under 35 years or over 65 years has not been studied
The safety and effectiveness of JUVEDERM® XC for areas other than facial wrinkles and folds, and JUVEDERM VOLUMA® XC for areas other than the mid face have not been established in 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 chemical peeling, as there is a possible risk 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 a higher risk for side effects
Tell your health care professional if you are on immunosuppressive therapy used to decrease the body’s immune response. Use of these products may result in an increased risk of infection
Tell your health care professional 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, or alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most common side effects are redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration With JUVEDERM® XC, most side effects are mild or moderate, and last 14 days or less. For JUVEDERM VOLUMA® XC, side effects are moderate (uncomfortable), and last 2 to 4 weeks.
One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin.
As with all skin-injection procedures, there is a risk of infection.
To report a side effect with JUVEDERM® XC or JUVEDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see www.juvederm.com or call the Allergan Medical Information line at 1-800-433-8871.
Available by prescription only.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
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.
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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 (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.