LAVAL - Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world, today announced that ARAZLO (tazarotene) Lotion, 0.045%, is available commercially to health care professionals in the United States this week.

Approved by the U.S. Food and Drug Administration (FDA) in December 2019, ARAZLO is the first tazarotene acne treatment available in lotion formulation.

'Retinoids like tazarotene are highly effective in treating acne and considered a cornerstone of acne treatment, but often are perceived to be associated with skin irritation.1 Clinical studies have demonstrated that ARAZLO's proprietary formulation provides the proven efficacy of a retinoid in a lotion that is more tolerable to patients than a higher concentration tazarotene,' said Bill Humphries, president, Ortho Dermatologics. 'Ortho Dermatologics remains committed to bringing forward new treatment options like ARAZLO to help the millions of Americans who suffer from acne.'

In a Phase 2, head-to-head study, ARAZLO and Tazorac (tazarotene) Cream 0.1% showed similar treatment success rates and similar reductions in both inflammatory and non-inflammatory lesions over 12 weeks and ARAZLO was associated with about half the number of adverse events and fewer treatment-related adverse events.1

'The novel lotion formulation of ARAZLO has been shown to be generally well-tolerated, allowing more patients with multiple types of acne to take advantage of its efficacy1,' said Emil Tanghetti, M.D., lead ARAZLO study investigator and founder of the Center for Dermatology and Laser Surgery, Sacramento, Calif. 'I am excited to offer ARAZLO to my patients and anticipate they will be pleased with their results.'

ARAZLO is priced comparable to many other branded acne products indicated to treat moderate-to-severe acne vulgaris. For most eligible patients whose commercial insurance covers the product, they should have no co-pay (or $0 co-pay) when utilizing the ARAZLO coupon at participating pharmacies. Most other eligible, commercially insured patients will have a co-pay of as little as $65 through our access program.

ARAZLO Comprehensive Clinical Data

The FDA approval for ARAZLO was based on data from two Phase 3 multicenter, randomized, double- blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p

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