Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, announced the U.S. launch of CABTREO (clindamycin, adapalene, benzoyl peroxide) Topical Gel, 1.2%/0.15%/3.1% indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. CABTREO Topical Gel is the first and only U.S. Food and Drug Administration-approved fixed-dose, once-daily triple-combination topical treatment for acne and offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. The FDA approved CABTREO Topical Gel on October 20, 2023, based on data from two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies that demonstrated CABTREO Topical Gel resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle.

At week 12, 50.0% of participants achieved treatment success with CABTREO versus 22.6% with vehicle gel (P<0.001). CABTREO resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9%% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P<0.001, both). The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.