Mr. Thomas Appio reports

CABTREO (CLINDAMYCIN PHOSPHATE, ADAPALENE AND BENZOYL PEROXIDE) TOPICAL GEL FOR THE TREATMENT OF ACNE VULGARIS NOW AVAILABLE IN THE U.S.

Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, have launched, in the United States, Cabtreo (clindamycin, adapalene and benzoyl peroxide) topical gel, 1.2 per cent/0.15 per cent/3.1 per cent, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

"With today's launch of CABTREO, millions of Americans who suffer from acne each year have access to a new once-daily triple-combination topical acne treatment," Thomas J. Appio, Chief Executive Officer, said. "In many instances, acne treatment requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen."

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 Oct. 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 (P70% 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.

About Acne Vulgaris

Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2

What is CABTREO?

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina.

About Ortho Dermatologics

Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of conditions, including psoriasis, onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. More information can be found at https://www.ortho-dermatologics.com.

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

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