Medytox secures Thai FDA approval for hyaluronic acid filler Atiere

Korean biopharmaceutical company Medytox said Friday that it has secured approval from Thailand's Food and Drug Administration for its hyaluronic acid (HA) filler, Atiere.

The product includes two formulations: Atiere Volume, designed with large HA particles for enhancing areas with significant volume deficiency, and Atiere Intensive, which features medium-sized particles for treating moderately deep wrinkles.

This marks Atiere's second international approval, following its debut in Indonesia in June. Medytox plans to expand Atiere’s availability to additional countries, complementing its established HA filler brand Neuramis, which is approved in 35 countries, including Thailand.

“The approval of Atiere in Thailand provides strong momentum for Medytox's global filler market strategy,” a company official said, adding that the company plans to promote the product locally to create synergy with its botulinum toxin (BTX), Meditoxin, which resumed sales last year. 

Meditoxin had been temporarily halted in 2020 after the Ministry of Food and Drug Safety (MFDS) revoked its license over the use of unapproved raw materials. However, the Daejeon High Court recently ruled the MFDS's actions were excessive and reinstated the product’s license.

Atiere was developed using Medytox's proprietary H.E.A.R.T. technology (High, Elastic, Advanced, Rheological, Throughput), designed to optimize elasticity and viscosity in HA fillers. The product uses U.S. FDA-registered hyaluronic acid and is certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM). Its manufacturing process eliminates animal-derived media and enzymes, reducing the risk of contamination, according to the company.