Ortho Dermatologics’ Altreno lotion gets FDA approval for Acne treatment

Ortho Dermatologics, a division of Bausch Health Companies, has achieved a significant milestone with the FDA approval of Altreno lotion (tretinoin 0.05%) for the treatment of acne vulgaris in patients aged 9 years and older. This approval marks Altreno as the first tretinoin formulation available in a lotion format, designed to enhance patient experience with added moisturizing benefits.

Altreno lotion’s approval underscores Bausch Health Companies’ commitment to expanding their acne treatment portfolio with innovative formulations. Scheduled for launch in the fourth quarter of this year, Altreno is expected to provide dermatologists and patients with a trusted option that combines efficacy with enhanced tolerability.

Altreno incorporates moisturizing components such as hyaluronic acid, glycerin, and collagen, ensuring ease of application and quick absorption into the skin. Bill Humphries, President of Ortho Dermatologics, highlighted the product’s attributes, stating, “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.”

The approval was supported by robust clinical data from two phase 3 trials involving 1,640 patients, where Altreno demonstrated significant reductions in both inflammatory and non-inflammatory lesions compared to the vehicle control. This efficacy profile positions Altreno as a promising treatment option for acne patients seeking effective results with minimal irritation.

The FDA approval of Altreno represents a significant advancement in acne treatment options, particularly with its unique formulation in lotion form. This innovation not only addresses the therapeutic needs of patients but also improves the overall user experience by incorporating moisturizing elements. Altreno’s anticipated market entry is poised to set a new standard in acne care, offering dermatologists a valuable tool in managing this common skin condition.