Almirall is expected to launch Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) of the face or scalp in the first quarter of 2021, after receiving FDA approval this week. 

Klisyri® is a novel, topical first-in-class microtubule inhibitor with a short treatment protocol (once daily application for 5 days), and proven efficacy and safety profile. 

With a reported prevalence of between 11% and 25%, actinic keratosis is the second most common diagnosis made by dermatologists in the US.

FDA approval of Klisyri® is based on data from one of the largest Phase III clinical study programs ever conducted for a topical AK treatment. The program consisted of two pivotal, randomized, double-blind, vehicle-controlled Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of Klisyri® (tirbanibulin) ointment 1% in adults with actinic keratosis on the face or scalp.

"These studies enrolled a total of 702 patients across 62 sites in the United States, providing robust data. Tirbanibulin achieved a significantly higher number of patients with complete (100%) clearance of AK lesions in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2), as well as reaching the secondary endpoint of partial (≥75%) clearance of lesions," says Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center, and one of the lead investigators of the studies.

"Early diagnosis and treatment of actinic keratosis (AK) is critical, since those who already have an AK are likely to develop more actinic keratoses (plural) in the future," says Deborah S. Sarnoff, MD, President of the Skin Cancer Foundation. "Patients with AK are at higher risk for skin cancer, since AKs can progress into squamous cell carcinoma (SCC), a common and sometimes invasive form of skin cancer."