Galderma Announces Top-Line Results of Clinical Study Showing Patients Treated with Dysport® (abobotulinumtoxinA) Achieved High Levels of Satisfaction and Natural-Looking Results with Two Treatments Per Year

Galderma Announces Top-Line Results of Clinical Study Showing Patients Treated with Dysport® (abobotulinumtoxinA) Achieved High Levels of Satisfaction and Natural-Looking Results with Two Treatments Per Year

PR Newswire

LAUSANNE, Switzerland, May 12, 2020

Company to Hold GAIN Live Webinar with DREAM Investigator Tomorrow, May 13, at 7 p.m. CDT

LAUSANNE, Switzerland, May 12, 2020 /PRNewswire/ -- Galderma today announced results of DREAM (Dysport Real-world Evaluation and Measured satisfaction study), a clinical study of Dysport®* (abobotulinumtoxinA) for Injection that evaluated patient satisfaction and safety with a twice-yearly treatment schedule. Top-line results showed that 95% of patients treated with Dysport achieved high levels of satisfaction with two treatments per year, and 97% of patients thought the result of the treatment looked natural.1 Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.

"As a physician in practice for nearly two decades, I have many long-standing patients who come in for retreatment with neuromodulators every three to four months. In the DREAM study, we were interested in evaluating patient satisfaction with a regimen in which Dysport was administered on a twice-yearly schedule," said Joel L. Cohen, M.D.**, a board-certified and fellowship-trained dermatologist and Director of AboutSkin Dermatology and DermSurgery in Colorado, and an investigator for the DREAM study. "We were encouraged to find in this Phase 4 study that close to 100% of patients were satisfied or highly satisfied with the aesthetic results of treating the lines between their eyebrows every six months for a year with Dysport. These top-line results suggest that aesthetic specialists can feel confident administering injections that match patient goals of treatment efficacy from every three to four months to a twice-yearly schedule."

DREAM Study Design and Results1
The open-label, multicenter, interventional Phase 4 DREAM study enrolled 120 patients ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Of those, 90% were female and one-third (33%) were toxin-naïve. The primary objective of the study was patient satisfaction, which was assessed by directly questioning study participants at 12 months and giving them the option of responding with "highly satisfied," "satisfied," "dissatisfied," or "highly dissatisfied." Secondary objectives included patient satisfaction as assessed by the 5-point Likert questionnaire and the FACE-Q scales measuring subject's psychological function and appraisal of lines between the eyebrows. DREAM was conducted at six sites in the United States. Patients were followed for 13 months to evaluate safety.

After receiving Dysport injections at the start of the study and then six months later, patients were assessed six months after that (12 months after the study began). Key top-line results of this study are as follows:

Primary Objective

Secondary Objectives

Only one patient (0.8%) experienced a treatment-related adverse event (mild injection site bruising).

"Today's announcement underscores our commitment to growing the aesthetic market and continuing to drive innovation so that patients can embrace injections with confidence," said Alisa Lask, Vice President and General Manager of Galderma U.S. Aesthetics. "We are thrilled with the top-line findings from the DREAM study demonstrating high levels of patient satisfaction and natural-looking results with Dysport when given twice a year. We anticipate publishing full results from DREAM, the first clinical study to evaluate this treatment schedule, in the coming months."

GAIN Live Webinar on DREAM Details
As part of Galderma's GAIN (Galderma Aesthetic Injector Network) live webinar series for aesthetic specialists, the company is hosting a webinar on the DREAM study featuring study investigators Dr. Joel Cohen and Dr. Carolyn Jacob tomorrow, Wednesday, May 13, at 7 pm CDT. To register, visit https://webinars.gainhcp.com/index/useraccess and use access code "GAINweb2020."

To sign-up for future webinars, please contact your local Galderma representative for access. Upcoming global GAIN webinar on the DREAM study featuring Dr. Andreas Nikolis will take place, Wednesday, May 20, at CET 9 am, 12 am and 6 pm***.  

About GAIN
Galderma Aesthetic Injector Network (GAIN) connects an international faculty of Aesthetic experts and injectors across the globe. Galderma offers a premium training program to ensure healthcare practitioners know how to use Galderma products in the most secure and efficient way. Galderma yearly offers training for thousands of health care practitioners. 

About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com.

Media Contacts
Isabella Laihorinne Smedh
PR & Communications
Galderma Aesthetics Global Business Unit
media@galderma.com

Shannon Iwaniuk
Corporate Communications, Galderma Laboratories, L.P.
media@galderma.com

1 Data on file. Study 43USD1802. Galderma, Uppsala., 2020.
* Please see full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the end of this press release.
** Paid Galderma consultant
*** availability is subject to local requirements based on the country of residence of the HCP.

Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport® is also marketed as Azzalure in EU for the treatment of glabellar lines with more than 40 million treatments in the EU and US combined and approval in 72 countries.

Important Safety Information
What is the most important information you should know about Dysport? Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are preexisting before injection.

These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.

The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.

Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert‐Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also been reported.

Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can't be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.

Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any 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, or take a sleep medicine.)

Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.

Ask your doctor if Dysport is right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA or relevant local regulator.

Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

For U.S. audiences please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.

©2020 Galderma Laboratories, L.P. All Rights Reserved. The Dysport trademark is used under license. All trademarks are the property of their respective owners.

Photo - https://mma.prnewswire.com/media/1166753/Dysport_Box_Vial_Image.jpg
Logo - https://mma.prnewswire.com/media/828206/Galderma_Logo.jpg  

Voltar noticias em Inglês