Galderma To Present Five Abstracts in Support of Novel Aesthetics Solutions and Pipeline at ASDS 2020 Annual Meeting
Company announces Phase 3 READY program of its proprietary, novel, liquid formulation of an investigational botulinum toxin for the treatment of glabellar lines and lateral canthal lines is fully enrolled
Fort Worth, Texas – October 9, 2020 – Galderma today announced the presentation of data from clinical trials of its aesthetic solutions and pipeline in five abstracts at the virtual American Society for Dermatologic Surgery (ASDS) 2020 Annual Meeting. The company also announced that it has completed patient enrollment in several clinical trials supporting a Phase 3 program of relabotulinumtoxinA (QM1114), its proprietary novel, ready-to-use, liquid formulation of investigational botulinum toxin, for the treatment of glabellar lines and lateral canthal lines. The Phase 3 program, called READY (RElabotulinumtoxin Aesthetic Development studY), enrolled over 1,900 patients across 60 sites in the United States and Canada in four clinical trials – three multi-center, randomized, double-blind, placebo-controlled studies and one long-term open-label study.
RelabotulinumtoxinA clinical trials will evaluate rapid onset, long duration, and additional patient measures as part of the large clinical program for this next generation botulinum toxin. The liquid formulation will be ready to use upon arrival and will not require in-office reconstitution before administration, it will reduce preparation time, and has the potential to increase accuracy and improve patient outcomes, in contrast with current treatments that require reconstitution by clinicians before administration. Derived from Galderma’s proprietary strain of Clostridium botulinum bacteria and created using an animal-origin free process, relabotulinumtoxinA will be manufactured in Galderma’s new state-of-the-art Center of Excellence in Aesthetics in Uppsala, Sweden.
“Our patient-first approach to aesthetics innovation has resulted in seven FDA approvals over the last six years. Based on the success of the latest outcomes we’ve shared today, and our continued work to bring patients safe and long-lasting results, we also expect to receive six more approvals in the next three years,” said Alisa Lask, General Manager and Vice President of U.S. Aesthetics at Galderma. “The launch of Restylane® Kysse earlier this year has shown the strong demand for new aesthetic solutions to improve the patient and provider experience throughout 2020. Our robust Phase 3 and Phase 4 clinical programs have helped propel the launch of Restylane Kysse, and the data presented today underscores our relentless focus on meeting the needs of our customers.”
Galderma’s Data Presentations at ASDS 2020
During the ASDS meeting, Galderma will present clinical research findings across its neurotoxin and dermal fillers portfolio. The company’s oral and poster presentations will highlight results from the DREAM (Dysport Real-world Evaluation and Measured satisfaction) study of Dysport® (abobotulinumtoxinA) for Injection*, which demonstrated high levels of patient satisfaction and natural-looking results with only two treatments per year1. Additionally, Phase 3 clinical research showed that Restylane® Defyne was effective for correction of chin retrusion and was associated with a high degree of patient satisfaction, and Restylane® Kysse was shown to be effective for lip augmentation over a 48-week treatment period with a high degree of patient satisfaction. In a Phase 4 study of Restylane Kysse, both subjects and their partners were satisfied with the subjects’ lips after treatment. 2,3
“The results of the DREAM study showing the long duration of Dysport and high patient satisfaction with treatments given twice a year are especially important as it’s the first toxin to showcase this extended patient satisfaction benefit,”1 said Dr. Carolyn Jacob, MD, FAAD, Founder and Medical Director of Chicago Cosmetic Surgery and Dermatology and an investigator for the DREAM study. “The study data showing that 95% 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 should give patients and aesthetic specialists confidence in this treatment regimen.”1
Details about Galderma’s presentations are as follows:
- A randomized, no-treatment controlled, evaluator-blinded, multi-center phase 3 study to evaluate the effectiveness and safety of HARD in the chin for augmentation and correction of chin retrusion – Dr. Anne Chapas (Oral Abstract: Friday October 9, 9:09-9:12 a.m.)
- A randomized, controlled, evaluator-blinded, multicenter study to evaluate the effectiveness and safety of HAkys versus a control in augmentation of soft tissue fullness of the lip – Dr. Sue Ellen Cox (Oral Abstract: Friday October 9, 9:03-9:06 a.m.)
- Post marketing study to evaluate lip enhancement, naturalness, and satisfaction of both subject and partner after treatment with HARK – Dr. Vince Bertucci (Oral Abstracts #5: Saturday, October 10, 11:30-11:33 a.m.)
- Subjects are highly satisfied with two treatments of abobotulinumtoxinA a year: results from multi-center, year-long, longitudinal study – Dr. Ava Shamban (e-poster)
- A randomized, evaluator-blinded, multi-center phase 3 study to evaluate safety and effectiveness of a biostimulatory poly-l-lactic acid injectable implant after changes in reconstitution – Dr. Melanie Palm (e-poster)
*Please see full Important Safety Information for Dysport®, including Distant Spread of Toxin Effect Boxed Warning, at the end of this document
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 neuromuscular disorder indications in countries around the world.
For more information on Ipsen, visit www.ipsen.com.
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/us.
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.
Follow Galderma on Instagram at @GaldermaAestheticsUSA.
Corporate Communications, Galderma Laboratories, L.P. [email protected]
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RESTYLANE FAMILY 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® Refyne, Restylane® Defyne and Restylane® Kysse.
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.
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.
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 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. 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 your relevant local regulator.
Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
The Dysport trademark is used under license. All trademarks are the property of their respective owners.
©2020 Galderma. All Rights Reserved.
1 Data on File. Study 43USD1802. Galderma, Fort Worth, TX, 2020.
2 Galderma. Clinical Study Report: Post Marketing Study to Evaluate Lip Enhancement, Naturalness and Partner/Subject Satisfaction after Treatment with Restylane® Kysse N/A Restylane Kysse 2020; 29.
3 FDA. Restylane Kysse Instructions for Use (IFU) N/A Restylane Kysse 2020.