Klisyri Launches for Treatment of AKs

Klisyri® (tirbanibulin) ointment 1% is now available from Almirall, SA for the topical treatment of actinic keratosis (AK) of the face and scalp. Klisyri is supplied in boxes of 5 single-use sachets and is applied to the treatment area once daily for five days.

"Klisyri will help address unmet needs for many AK patients," says George Martin, MD, a world-renowned expert in actinic keratosis and skin cancer. "Early diagnosis and a safe and highly effective topical for treatment of actinic keratosis is critical. Patients with actinic keratoses are at higher risk for developing non-melanoma skin cancer. Actinic keratosis can progress into squamous cell carcinoma (SCC), a common and sometimes invasive and deadly form of skin cancer."

The FDA approved the novel, topical, first-in-class microtubule inhibitor in December 2020 based on data from one of the largest Phase III clinical study programs ever conducted for a topical AK treatment, consisting 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 in adults with AKs on the face or scalp.

Klisyri met the primary endpoint and achieved a significantly higher number of patients with complete (100 percent) clearance of AK lesions at day 57 in the treated area compared to vehicle (44 percent vs. five percent in study 1 and 54 percent vs. 13 percent in study 2; p<0.0001 for both studies). It also met the secondary endpoint of partial (≥75%) clearance of lesions at day 57 compared to vehicle. The most common adverse events were application-site pruritus and pain seen in nine percent and 10 percent of patients treated with Klisyri.