Mr. Bill Humphries reports

ORTHO DERMATOLOGICS RECEIVES FDA APPROVAL FOR ALTRENO (TRETINOIN 0.05%) LOTION FOR ACNE

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc., has received United States Food and Drug Administration (FDA) approval for the new drug application for Altreno (tretinoin 0.05 per cent) lotion, indicated for the topical treatment of acne vulgaris in patients nine years of age and older. Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well tolerated. Altreno is expected to be available during the fourth quarter of 2018.

"Today's FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user's experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen," said Bill Humphries, president, Ortho Dermatologics. "Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen."

Extensive clinical data have shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness and peeling, and sensitivity. In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in 4 per cent of patients.

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Dr. Joshua Zeichner, MD, director, cosmetic and clinical research in dermatology, The Mount Sinai Hospital, New York. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

Altreno clinical data

Altreno was evaluated in two identical multicentre, randomized, double-blind, vehicle-controlled phase 3 studies, totalling 1,640 patients to determine its safety and efficacy. The data demonstrated that Altreno lotion resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared with vehicle. In the population of patients treated in these studies, patients treated with Altreno saw a mean absolute reduction of 13.1 and 13.9 in inflammatory lesions in trials 1 and 2, respectively, compared with 10.6 and 10.7 in patients treated with vehicle. In addition, those treated with Altreno saw a mean absolute reduction of and 17.8 and 21.9 in non-inflammatory lesions in trials 1 and 2, compared with 10.6 and 13.9 in patients treated with vehicle. Also at week 12, 16.5 per cent and 19.8 per cent of patients in trials 1 and 2, respectively, achieved treatment success (at least a two-grade improvement in global severity by Evaluator Global Severity Scores and clear or almost clear) with tretinoin 0.05 per cent lotion, compared with only 6.9 per cent and 12.5 per cent with vehicle.

The most common adverse reactions occurring in greater than 1 per cent of subjects and greater than vehicle were dryness, pain erythema, irritation and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Use Altreno with caution if allergic to fish due to potential for allergenicity to fish protein.

The clinical trial data also showed patient satisfaction (as assessed by 1,396 patient satisfaction surveys completed at week 12) was significantly greater with Altreno lotion by week 12, with patient satisfaction of those treated with Altreno lotion increased by 53 per cent compared with 43 per cent with vehicle (P less than 0.001). Nine out of 10 patients reported that they were satisfied with their treatment. Patients in the treatment group saw a statistically significant increase in mean Acne-QoL assessments compared with vehicle; increase in mean scores from baseline to week 12 with Altreno were 7.4 (self-perception, versus 6.7 for vehicle, P equals 0.003), 6.8 (role-emotional, versus 6.0, P equals 0.003), 4.8 (role-social, versus 4.6, P equals 0.038) and 6.5 (acne symptoms, versus 5.6, P less than 0.001).

About acne vulgaris

Acne is a skin condition that occurs when hair follicles become plugged with oil and skin cells, often causing whiteheads, blackheads or pimples and appearing on the face, forehead, chest, upper back and shoulders. Acne is most common among people ages 12 to 24, though it can affect people of all ages. Depending on its severity, acne can cause emotional distress and scar the skin.

Acne is the most common skin problem in the United States. Up to 50 million Americans have acne.

About Ortho Dermatologics

Ortho Dermatologics, a Bausch Health company, is one of the largest prescription dermatology companies in the world dedicated to helping patients in the treatment of a range of therapeutic areas, including actinic keratosis, acne, atopic dermatitis, psoriasis, cold sores, athlete's foot, nail fungus and other dermatoses.

About Bausch Health Companies Inc.

Bausch Health Companies is a global company whose mission is to improve people's lives with its health care products. It develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. The company is delivering on its commitments as it builds an innovative company dedicated to advancing global health.

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