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Galderma leads oral presentation on hyaluronic acid filler safety insights at ASDS 2021 Annual Meeting

November 22, 2021

Galderma presented eight abstracts in support of innovative aesthetics solutions and pipeline, including post-marketing safety surveillance study abstract named to “Best of Cosmetic Oral Abstracts” list

 

Fort Worth, Texas – November 22, 2021 – Galderma announced the presentation of data supporting its aesthetics portfolio and pipeline at the virtual American Society for Dermatologic Surgery (ASDS) 2021 Annual Meeting, which took place November 19-21, 2021. Eight abstracts from investigator-initiated and Galderma-sponsored trials were accepted, including one oral presentation of a hyaluronic acid (HA) filler safety abstract.

“We are excited to share new data as part of our commitment to advancing dermatology and aesthetics,” said Carrie Caulkins, Vice President, U.S. Aesthetics Marketing at Galderma. “Our participation and inclusion in ASDS this year underscores our continued focus on delivering safe and effective products for aesthetic professionals and their patients.”

Board-certified dermatologist, fellowship-trained in aesthetic dermatology, and Galderma clinical trial investigator Joel L. Cohen, MD, presented the compilation of HA filler safety data in an oral presentation titled Post-Marketing Safety Surveillance of Delayed Complications for Recent FDA-Approved Hyaluronic Acid Dermal Fillers.

Leveraging reports from the Manufacturer and User Facility Device Experience (MAUDE) database, the surveillance study analyzed delayed-onset (≥14 days) adverse events (AEs) of interest (inflammatory and non-inflammatory nodules, hypersensitivity, granulomas) for HA fillers FDA-approved between 2016-2020.  While reports of delayed-onset nodules and inflammatory events were uncommon in clinical practice, a retrospective review of reports from the MAUDE database found the rate of occurrence to be low among products formulated with Galderma’s unique manufacturing process, XpresHAn Technology™.1

“The study data showcases Galderma’s dedication to creating treatments with patient safety in mind," said Dr. Cohen. “Compared to other HA fillers in the MAUDE database, the newer members of the Galderma portfolio formulated with XpresHAn Technology™, Restylane® Defyne, Restylane® Refyne and Restylane® Kysse had a lower percentage of delayed adverse events of interest.”1 The abstract was one of 10 to earn a spot on the “Best of Cosmetic Oral Abstracts” list.

Galderma also shared data showcasing high patient satisfaction with two treatments a year (every six months) of Dysport®† (abobotulinumtoxinA), among those both previously treated and neuromodulator-naïve.

Please see full Important Safety Information for Dysport, including Distant Spread of Toxin Effect Boxed Warning, at the end of this article.

Galderma presented clinical research findings across its neuromodulator and dermal filler portfolio. Details about Galderma’s presentations are as follows: 

 

Main Session Oral Presentation

 

RESTYLANE®

Post-marketing safety surveillance of delayed complications for recent FDA-approved hyaluronic acid dermal fillers

Presented by Joel Cohen, MD

“Best of Cosmetic Oral Abstracts” session

Sunday, November 21st, 2021

2:45-2:50p

 

E-Poster Presentations

 

SCULPTRA® AESTHETIC

An open-label extension study to evaluate safety and effectiveness of a biostimulatory poly-L-lactic acid injectable implant after changes in reconstitution and injection procedure

Presented by Susan Weinkle, MD

 

DYSPORT®

Subject Satisfaction with Two Treatments a Year (Every Six Months) of AbobotulinumtoxinA is High Among Both Previously Treated and Toxin-naïve Cohorts

Presented by Joel Cohen, MD

Brow Shape and Height After Treatment with AbobotulinumtoxinA in the Glabellar Lines

Presented by Joel Cohen, MD

Subject-relevant Outcomes of On-label 50U AbobotulinumtoxinA Treatment for Moderate-to-Severe Glabellar Lines across Three Individual Trials

Presented by Sue Ellen Cox, MD

A Randomized, Double-Blind, Placebo-Controlled Study of a New Dilution and Injection Volume of AbobotulinumtoxinA for Treatment of Glabellar Lines

Presented by Deanne Mraz Robinson, MD, FAAD

A Randomized, Dose-Escalating, Double-Blind Study to Evaluate AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines

Presented by Joely Kaufman-Janette, MD

Relabotulinum Toxin – A Novel, High-Purity BoNT-A1 in Liquid Formulation

Presented by Alessandra Nogueira, MD

 

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.

Please see full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the bottom of the page.

For more information, the full ASDS 2021 program is available here: https://www.asds.net/medical-professionals/annual-meeting#AM21-Program

 

About Galderma

Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com/us.

 

About Galderma’s RESTYLANE Product Portfolio

With over 50 million treatments worldwide2 and counting, the RESTYLANE family of HA dermal fillers is a diverse and broad portfolio of dermal fillers in the U.S. These products help smooth facial wrinkles and folds, such as smile lines (RESTYLANE L, RESTYLANE REFYNE, RESTYLANE DEFYNE and RESTYLANE LYFT with Lidocaine), augment and correct mild to moderate chin retrusion (RESTYLANE DEFYNE), create fuller and more accentuated lips (RESTYLANE SILK, RESTYLANE-L and RESTYLANE KYSSE), add lift and volume to the cheeks and back of the hands (RESTYLANE LYFT with Lidocaine), and augment cheeks and correct midface contour deficiencies (RESTYLANE CONTOUR).

 

About SCULPTRA AESTHETIC

SCULPTRA AESTHETIC works to stimulate the skin’s own collagen production and is for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. SCULPTRA AESTHETIC is an injectable biostimulator containing microparticles of poly-L-lactic acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months. SCULPTRA AESTHETIC was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.

 

About Galderma’s collaboration with Ipsen

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 the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.

DYSPORT is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen’s botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote DYSPORT within certain therapeutic indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.

 

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

 

Follow Galderma on Instagram at @GaldermaAestheticsUSA.

 

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Investor and media relations

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 21 642 71 99

 

Media

Shannon Iwaniuk

Director of Communications

shannon.iwaniuk@galderma.com

 

IMPORTANT SAFETY INFORMATION

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.

 

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

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

 

RESTYLANE IMPORTANT SAFETY INFORMATION

The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour.

 

APPROVED USES

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.

Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.

Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.

Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.

The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, 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 any Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722.

To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.

 

SCULPTRA AESTHETIC IMPORTANT SAFETY INFORMATION

Indication: Sculptra® Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

Sculptra Aesthetic should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.

Sculptra Aesthetic has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.

Sculptra Aesthetic should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra Aesthetic should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.

The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.

Sculptra Aesthetic is available only through a licensed practitioner. Complete Instructions for Use are available at www.SculptraAesthetic.com

 

References

‡ Clinical trial ended at 25 months

  1. Galderma. Clinical Study Report: Post-marketing safety surveillance of delayed complications for recent FDA-approved hyaluronic acid dermal fillers
  2. Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.
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