A Decade of Dysport®: Galderma Celebrates 10 Years Since FDA Approval of Dysport in the U.S.

Spotlighting the long-term safety and efficacy profile of Dysport for aesthetic use and the natural results yielding high patient satisfaction

News provided by

Galderma

Apr 30, 2019, 09:48 ET

FORT WORTH, Texas, April 30, 2019 /PRNewswire/ -- Galderma Laboratories, L.P., a global leader focused on meeting the world's increasing skin health needs, proudly celebrates the 10-year FDA approval anniversary of Dysport (abobotulinumtoxinA) for Injection*.

Over the past 10 years, Dysport has established its legacy through various milestones – the brand is approved for clinical use in 72 countries, backed by over 25 years of clinical investigation worldwide in both therapeutic and aesthetic use, and has an established long-term safety profile with a 36-month long-term study. Dysport is fast-acting and long-lasting with natural-looking results to smooth frown lines between the eyebrows. In clinical studies, more than half of users saw improvement in their frown lines in as little as 2-3 days and the results lasting for up to five months.^1-4Dysport also has a high patient satisfaction rate, with 97% of users⁺ saying they would receive the treatment again and recently, Dysport received a 97% "Worth It" rating on RealSelf, making it among the top 10 highest satisfaction ratings for all nonsurgical treatments in 2019.⁵

"Dysport's legacy on the market over the past decade is proof of Galderma's ongoing commitment to invest in innovation that drives an impact with our customers and their patients. Dysport has outgrown the market for the past three years and we anticipate continued growth through investments in additional clinical studies evaluating duration and patient satisfaction," said Alisa Lask, Vice President and General Manager of Galderma's U.S. Aesthetic Business. "The aesthetics market has grown exponentially since the approval of Dysport, and Galderma will remain focused on continuing to drive this growth by providing innovative products and services that help our customers grow their practices."

In addition to strong safety and efficacy, recent post-approval clinical studies have demonstrated Dysport patients experience results positively affecting their psychological well-being as well. When asked 30 days after their Dysport treatment, 92% of patients reported feeling confident, 90% of patients reported looking natural and 92% of patients felt they looked attractive. Even four months post-treatment, patients reported looking at least four years younger than their actual age.⁶

"As a loyal Dysport customer since its FDA approval, I'm pleased to celebrate this important milestone 10 years later," said Dr. Joel Schlessinger**, board-certified dermatologist in Omaha, NE. "Dysport is a remarkable aesthetic product that has proven incredibly successful in my practice and I am grateful to have been involved in its clinical development and approval over 10 years ago. Since its approval, I have come to rely on the safe, effective and natural-looking results my patients receive with Dysport, and I appreciate Galderma's ongoing support to drive patients into my practice with consumer promotions."

Over 400,000 new Dysport patients are entering the ASPIRE Galderma Rewards program each year – a sign that the aesthetic market is continuing to grow rapidly. To celebrate this, Galderma is offering double points for Dysport aesthetic treatments registered in the consumer loyalty program through July 31, 2019***, which patients can redeem for discounts on their next treatment. Additionally, in select U.S. markets, Dysport is partnering with charitable organizations including Dress for Success and the National Coalition Against Domestic Violence, to donate money for every patient treatment registered****.

Through ongoing investments in clinical trials, product promotions, and collaboration partnerships, Galderma remains committed to growing the aesthetic market. The milestone of Dysport's 10-year FDA approval underscores Galderma's commitment to invest in innovations that impact patients' lives and their customers' success.

*Please see full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the end of this press release.
**Clinical Trial Investigator
***Offer terms and conditions apply. For details, please visit www.aspirerewards.com.
**** Offer terms and conditions apply. See details at the end of this press release.

About Galderma
Galderma, Nestlé Skin Health's medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. 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.galdermausa.com and www.galderma.com.

To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

Contact
Shannon Iwaniuk
Corporate Communications, Galderma
[email protected]

Victoria Smurro
Marina Maher Communications
[email protected]
212.485.6816

⁺Users= clinical study subjects
¹Data on file. MA-Y-97-52120-719 (GL-1) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
²Data on file. MA-Y-97-52120-718 (GL-3) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
³Data on file. MA-Y-97-52120-085 (GL-2) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
⁴Data on file. MA-35497. Post Hoc Analysis. Fort Worth, TX: Galderma Laboratories, L.P., 2017.
⁵RealSelf. RealSelf Ranks the "Most Worth It" Surgical and Nonsurgical Aesthetic Procedures Based on Consumers' Worth It Ratings. 2019.
⁶Data on file. GLI.04.SRE.US10348 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2017.

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.

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 pre‐existing 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.

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

Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.

Dysport and National Coalition Against Domestic Violence Terms and Conditions For every patient who receives a facial aesthetic treatment with Dysport from a licensed healthcare provider in accordance with the product's FDA-approved indication and labeling that is recorded by the healthcare provider in the ASPIRE Galderma Rewards loyalty program, Galderma will contribute $25 to the National Coalition Against Domestic Violence, with a minimum total donation of $50,000 and a maximum total donation of $100,000. Charitable sales promotion begins April 10, 2019; ends June 30, 2019; and applies only to Georgia, North Carolina, South Carolina, and Tennessee (or selected portions thereof).

Dysport and Dress for Success Terms and Conditions For every patient who receives a facial aesthetic treatment with Dysport from a licensed healthcare provider in accordance with the product's FDA-approved indication and labeling that is recorded by the healthcare provider in the ASPIRE Galderma Rewards loyalty program, Galderma will contribute $100 to Dress for Success, with a minimum total donation of $100,000 and a maximum total donation of $120,000. Charitable sales promotion begins April 10, 2019; ends June 30, 2019; and applies only to Michigan; Ohio; and portions of Indiana, West Virginia, and Kentucky

The Dysport^® trademark is under license. All trademarks are property of their respective owners.

SOURCE Galderma