Ortho Dermatologics has secured approval from the US Food and Drug Administration (FDA) for its Altreno (tretinoin 0.05%) to treat acne vulgaris in patients nine years of age and older.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Ortho Dermatologics, a division of Bausch Health Companies, is focused on helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses.
The FDA has approved Ortho’s the new drug application for Altreno lotion as a topical treatment of acne vulgaris in patients nine years of age and older.
Altreno is said to be the first formulation of tretinoin in a lotion, and demonstrated to be effective treatment.
The company plans to make Altreno lotion commercially available to the customers in the fourth quarter of this year.
Ortho Dermatologics president Bill Humphries said: “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.
“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.”
According to the company, expanded clinical data has demonstrated that retinoids are effective in treating acne and are considered a cornerstone of topical therapy.
In clinical studies, Altreno lotion offered the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling and irritation.
Altreno was assessed in two identical multicenter, randomized, double-blind and vehicle-controlled phase 3 studies.
The studies, which recruited 1,640 patients to assess safety and efficacy, showed that Altreno lotion significantly reduced both inflammatory and non-inflammatory lesions compared against vehicle.
New York City’s Mount Sinai Hospital dermatology cosmetic and clinical research director Dr Joshua Zeichner said: “Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation.
“With the efficacy expected from a retinoid, plus a proven tolerability profile, ALTRENO will be an ideal choice for many of my patients.”