The #1 selling anti-wrinkle product has now been approved by the TGA for use in Australia.

Supported by positive results from three completed phase 3 trials that enrolled more than 1000 subjects in the U.S. and Europe, a new anti-wrinkle injectable product has been cleared for safe administration by the Therapeutic Goods Association (TGA).

The product, which is distributed by Croma in Australia, has been the market leader for six consecutive years in South Korea, one of the world’s most dynamic aesthetic markets, and is now available in 44 countries.

The anti-wrinkle product is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows in adults <75 years old seen at maximum frown (glabellar lines), when the severity of the facial lines has an important psychological impact. In each study, letibotulinumtoxinA was superior to a placebo at week 4. It was also shown to be non-inferior to the leading competitors, with a similar molecular profile of 900kDa. It was deemed effective and safe.

“We are thrilled with the TGA’s approval. This is a major milestone for Croma Australia as we focus on becoming a top aesthetics brand in Australia,” stated James Hartman, President, Hugel Aesthetics. “We are excited to deliver quality aesthetic solutions that are accessible and attainable, and we look forward to contributing to the expansion of the Australian medical aesthetics market.”

“Australia is in a unique position. We are a very small country by population, yet we are one of the top countries in adopting non-surgical rejuvenation therapy. Australians are curious and strive to look their best, perhaps due to our outdoor lifestyle. The addition, this new product that the TGA has recently approved, will significantly contribute to the aesthetic market. To me, it’s all about choice. It’s all about having another quality, anti-wrinkle injection to choose from; so that, as practitioners, we can provide the best outcome for our patients by assisting them to choose the best treatment for their needs.”

Steven Liew, world-renowned Plastic Surgeon, and Medical Director of Shape Clinic in NSW

With expectations to be available in Australia early 2023, injectors are encouraged to contact their Croma Australia account manager or email info@cromapharma.com.au for further information.

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