FORT WORTH, Texas-Wednesday 8 June 2022 [ AETOS Wire ]
(BUSINESS WIRE) -- Galderma, the leading company solely dedicated to advancing the future of dermatology, announced it will present four scientific presentations at the 2022 Vegas Cosmetic Surgery (VCS) & Aesthetic Dermatology Annual Symposium to showcase the latest advancements surrounding its approved and investigational product updates.
“We look forward to unveiling the latest data and research across our innovative dermatology pipeline and portfolio at this year’s VCS symposium,” said Bill Andriopoulos, Vice President, Medical Affairs Galderma U.S. “Our commitment to patients is underscored by the dermatological solutions we are investigating and bringing to market. We are excited to continue to realize the potential of our product portfolio and share our findings with the larger scientific community.”
The data presentations stem from Galderma’s neuromodulators relabotulinumtoxinA (QM1114), an investigational product, and Dysport® (abobotulinumtoxinA)* as well as its collagen stimulator, Sculptra® (injectable poly-L-lactic acid).
There will be two scientific presentations featuring the latest READY-1 and READY-2 Phase 3 data of relabotulinumtoxinA, a proprietary novel, ready-to-use, liquid formulation of investigational botulinum toxin, for the treatment of glabellar lines and lateral canthal lines. There will also be data presented from across three individual trials investigating the subject-relevant outcomes of on-label 50U Dysport for the treatment for moderate-to-severe glabellar lines. Additionally, data from NCT03780244, an open-label extension study to evaluate the safety and effectiveness of Sculptra after changes in reconstitution and injection procedure, will be presented at the symposium.
More details on Galderma’s activities can be found below.
Abstract Title
First
Author
Presentation
Date/Time (ET)
Abstract: Treatment of moderate-to-severe glabellar lines with relabotulinumtoxinA, an investigational liquid botulinum toxin: Clinical efficacy and safety results from the READY-1 Phase III trial
Dr. Sachin Shridharani
Friday, June 10, 2:30 – 4:00 PM
Abstract: Treatment of lateral canthal lines with relabotulinumtoxinA, an investigational liquid botulinum toxin: Clinical efficacy and safety results from the READY-2 Phase III trial.
Dr. Sheriff Ibrahim
Friday, June 10, 2:30 – 4:00 PM
Abstract: Subject-Relevant Outcomes of On-Label 50 U AbobotulinumtoxinA Treatment for Moderate-to-Severe Glabellar Lines Across Three Individual Studies
Dr. John Joseph
Friday, June 10, 2:30 – 4:00 PM
Abstract (e-poster): 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
Dr. Brenda LaTowsky
N/A
Galderma’s on-site medical booth will feature an interactive Gel Science lab and resources for attendees to learn more about the product science and latest research. Additionally, Galderma will host a medical advisory board on Thursday, June 9, 11 a.m. – 2 p.m. and a GAIN Lunch & Learn on Friday, June 10, 1:15 – 2:15 p.m. to share new research and findings across the portfolio, including live injections. Visit the Galderma website to learn more.
*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 read full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the bottom of the page.
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 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 and lateral canthal lines.
Dysport has more than 30 years of clinical experience Globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is licensed for aesthetic indications in 85 markets worldwide, Dysport is one of the world’s leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date.
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, Europe, the Middle East, 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.
About Sculptra®:
SCULPTRA® works to stimulate the skin’s own collagen production for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in people with healthy immune systems. SCULPTRA® is an injectable biostimulator containing microparticles of poly-L-lactic acid (PLLA) which gradually revitalizes the skin’s structural foundation to help smooth facial wrinkles such as smile lines, providing natural-looking, long-term results for up to 25 months. SCULPTRA was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.
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 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. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.
Indication: Sculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Important Safety Information
Sculptra 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 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 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 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 is available only through a licensed practitioner. Complete Instructions for Use are available at www.SculptraUSA.com/IFU.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220608005440/en/
Contacts
Media Relations
Zach Randles-Friedman
Head of U.S. Communications
Zach.randles-Friedman@galderma.com
+1 305 299 5700
Rachel Mooney
Director, Global Franchise Communications
rachel.mooney@galderma.com
+41 58 455 85 41 /+41 76 261 64 41
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