THORNHILL, ON, Aug. 14, 2018 /CNW/ - Galderma Canada, an emerging leader in Aesthetics, is pleased to announce that Health Canada has approved DYSPORT AESTHETIC™ (abobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet) in adult patients. DYSPORT AESTHETIC is also approved for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adult patients younger than 65 years of age.
An injectable treatment, the new application of DYSPORT AESTHETIC temporarily blocks the nerve activity in the muscles that cause crow's feet, or wrinkles, around the outer edges of the eyes.1
"The new indication for DYSPORT AESTHETIC adds to the strong body of clinical data that has supported the brand for the past 25 years," said Wendy Adams, General Manager of Galderma Canada. "As a leader in the aesthetic market, Galderma Canada is pleased to demonstrate our investment and commitment to building on our portfolio and continuing to provide innovative products with natural-looking results."
DATA THAT SUPPORTS APPROVAL1
The approval of DYSPORT AESTHETIC by Health Canada is based on the results of a double-blind, randomized, placebo-controlled, Phase 3 study that involved 335 subjects. The temporary improvement in the appearance of moderate to severe LCLs was assessed by investigators using a validated 4-point scale (none, mild, moderate, severe). In addition, subject satisfaction with the appearance of their lateral canthal lines (LCLs) was assessed as a secondary endpoint using a 4-level rating (very satisfied, satisfied, dissatisfied, very dissatisfied). Treatment success was defined as the proportion of responders at Week 4 on the severity of LCLs as none or mild at maximum smile. Duration of effect, compared with placebo, was assessed up to week 16. Results demonstrated that at week 4, DYSPORT AESTHETIC significantly reduced the severity of LCLs) compared with placebo at maximum smile. Duration of effect with DYSPORT AESTHETIC was seen for up to 12 weeks, the time-point when subjects were offered a re-treatment.
ABOUT DYSPORT AESTHETIC
DYSPORT AESTHETIC has been available globally for 25 years. It is currently approved for use in 24 countries and has been administered to 4,600 patients followed in 11 clinical trials.2 DYSPORT AESTHETIC can only be administered by dermatologists, plastic surgeons, primary care physicians and other healthcare professionals who have the appropriate qualifications and experience in the treatment and use of DYSPORT AESTHETIC.
The most commonly observed adverse reactions in the LCL studies were generally mild to moderate in severity and included eyelid edema, headache and injection site reactions (haematoma, itching, and swelling).1
Important and complete safety information about DYSPORT AESTHETIC can be found by accessing the product monograph.
To learn more about DYSPORT AESTHETIC, visit www.dysportcanada.ca.
Galderma, Nestlé Skin Health's medical solutions business, was created in 1981 and is now present in more than 100 countries with an extensive product portfolio to treat a range of dermatological conditions. Galderma is a leader in the research and development of scientifically-defined and medically-proven solutions for the skin. Partnering with healthcare practitioners around the world to meet people's skin health needs throughout their lifetime, the company contributes to Nestlé Skin Health's vision to change the way the world thinks about skin health.
For more information, visit www.galderma.ca.
1 PrDysport™ Aesthetic Product Monograph. Galderma Canada Inc. https://pdf.hres.ca/dpd_pm/00044977.PDF
2 Data on File, Galderma Canada Inc.
SOURCE Galderma Canada
For further information: Media Relations Contact: Viktoria Liepold, Cohn & Wolfe, [email protected], 647-259-3273