Watch as Dr James Del Rosso, DO, discusses the significance of the expanded indication, including the clinical efficacy, duration of treatment, and more 

Almirall has recently announced that the US Food and Drug Administration (FDA) has approved an expansion of the use of Klisyri (tirbanibulin) for the treatment of actinic keratosis (AK). Initially approved in December 2020 for smaller areas, this expansion will change the previous Klisyri dosing for surface area treatment from up to 25 cm² to up to 100 cm², allowing clinicians to treat a larger area of the face or balding scalp. 

This new approval significantly enhances the convenience and flexibility for both patients and dermatologists in managing more extensive manifestations of AK. 

Consistent safety and efficacy in larger treatment areas 

The FDA's approval was based on a robust Phase 3 clinical trial, which evaluated the safety and tolerability of applying Klisyri over an area of 100 cm² on the face or balding scalp, which is 4 times larger than the initially approved 25 cm². The study, conducted in multiple centers across the US, demonstrated that the safety and tolerability profiles of Klisyri in this expanded area are consistent with those observed in the original trials. Local skin reactions and adverse events remained in line with the initial findings. 

Availability and packaging 

Klisyri will be available in 2 package sizes to accommodate different treatment needs: a 250-mg package for treating up to 25 cm² and a new 350-mg package for treating up to 100 cm². This ensures that patients and healthcare providers have the appropriate resources to address varying degrees of AK.