Tirbanibulin 1% Ointment: Clinical Trial and Real-World Evidence on Efficacy, Tolerability, Safety, and Patient-Reported Outcomes.

Actinic keratosis (AK) is a skin lesion that arises due to chronic sun exposure. Treatment of all AKs is recommended due to their risk of progressing to squamous cell carcinomas (SCCs). Many field-directed treatments for AKs involve burdensome treatment duration and frequency, compromising treatment compliance. Tirbanibulin 1% ointment is a first-in-class microtubule inhibitor that treats AKs by inhibiting Src kinase signaling and inducing pro-apoptotic effects. It is an approved treatment for field-directed therapy of AKs, administered once daily for 5 consecutive days. In addition to its convenience of use, tirbanibulin 1% ointment has demonstrated efficacy and safety in phases 1 to 3 clinical trials and favorable clinical outcomes in real-world clinical studies. This paper summarizes the comprehensive evidence from clinical trials and global clinical studies to guide clinical consideration of tirbanibulin 1% ointment in AK management.