Hugel's 'Botulax' Published in International Journal for Phase 3 Clinical Trial... "Proven Efficacy and Safety in Improving Deep Glabellar Wrinkles"

Hugel Botulinum Toxin Product 'Botulex' (Export Name Retivo).

[Asia Economy Reporter Lee Gwan-joo] Hugel announced on the 26th that the results of the Phase 3 clinical trials of its botulinum toxin product 'Botulax' (export name Retivo) in the United States and Europe have been published in the SCI-level international journal 'Aesthetic Surgery Journal.'

The Phase 3 clinical trials were conducted on more than 1,200 patients with glabellar wrinkles using a randomized, double-blind, placebo-controlled method to evaluate the drug's efficacy and safety.

According to the study results, 94% of all patients showed improvement in glabellar wrinkles at the 4-week evaluation after administration, and the effect was maintained for 4 months. The median time to onset of effect was 3 days after administration, and about 25% of patients experienced a reduction in glabellar wrinkles within 24 hours after administration.

Additionally, 48.5% of patients with deep glabellar wrinkles showed excellent results of 'no wrinkles or almost none' at 4 weeks post-administration, and continuous efficacy, tolerability, and safety were confirmed with repeated administration over 12 months.

Based on these clinical results, Hugel is currently accelerating its expansion in the European market. After receiving a recommendation for product approval for Botulax 50 units from the Heads of Medicines Agencies (HMA) in January, it has recently obtained product approvals in 11 major countries including the 'Big 5' (United Kingdom, France, Germany, Italy, Spain).

A Hugel representative said, "We are pleased to once again demonstrate the competitiveness of Botulax through this global journal publication," adding, "We will make company-wide efforts to promote the differentiated value of Botulax through evidence-based marketing based on excellent product development, production, and academic activities, and to accelerate global market expansion."