Croma Aesthetics Canada Ltd. Receives Canadian Market Authorization for Letybo (LetibotulinumtoxinA for Injection) for the Treatment of Glabellar Lines

Authorization is supported by positive results from three completed phase 3 clinical trials
that enrolled more than 1000 subjects in the U.S. and Europe

TORONTO--(BUSINESS WIRE)--Croma Aesthetics Canada Ltd., doing business as Hugel Aesthetics, today announced it received a Notice of Compliance from Health Canada for Letybo (letibotulinumtoxinA for injection) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity (frown lines between the eyebrows) in adult patients under 65 years of age.

Dr Sheetal Sapra, MD, Board-certified Dermatologist and founder of ICLS Dermatology and Plastic Surgery in Oakville, Ontario commented, “Letybo provides a compelling new treatment option for physicians and their aesthetic patients. I look forward to incorporating it into my aesthetic product offering.”

LetibotulinumtoxinA has been the market leader for six consecutive years in South Korea, one of the world’s most dynamic aesthetic markets. With its recent approval in the EU, Letybo is now available in over 28 countries.

"We are thrilled with the authorization of Letybo in Canada. This is a huge achievement for Hugel Aesthetics as we focus on becoming a top aesthetics brand in Canada,” stated Bob Bennett, General Manager Hugel Aesthetics, Canada.

“We are excited to deliver high-quality and attainable beauty solutions and we look forward to expanding the Canadian aesthetic neurotoxin market."

“This is a significant milestone for Hugel Aesthetics and the first step in our plans to expand into additional markets, including the United States and Australia, in the near future,” said James Hartman, President, Hugel America, Inc (Hugel Aesthetics).

The Canadian authorization of Letybo was based on the results of three identical randomized, controlled, multicenter phase 3 clinical trials involving 1,272 subjects with moderate-to-severe glabellar lines. In each study, the primary endpoint was met; letibotulinumtoxinA (20 Units) was superior to placebo in reducing glabellar line severity at Week 4 based on a composite ≥2-point improvement in Facial Wrinkle Scale (FWS) score.

Health Care Professionals may contact their Hugel Aesthetics representative or email [e-mail] for product and ordering information.

About Croma/Hugel Aesthetics

Croma Aesthetics Canada Ltd. is a subsidiary of Hugel America, Inc. (Hugel Aesthetics), a growth focused joint venture between aesthetic market-leading partners Hugel, Inc., and Croma to develop and commercialize botulinum toxin, hyaluronic acid fillers, and additional aesthetic portfolio products in the United States, Canada, Australia, and New Zealand. Hugel Aesthetics is dedicated to making a difference by transforming patient experiences. For more information, visit us at www.hugel-aesthetics.com

References
Letybo Canadian Product Monograph. Date of Initial Authorization June 14, 2022

Data on File, Hugel, Inc.