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Bausch Health's Altreno acne lotion meets main goal of 2 late-stage trials

Bausch Health Cos. Inc. said its Altreno acne lotion delivered significantly better outcomes in two late-stage studies when compared to placebo.

The identical phase 3 studies enrolled 1,640 patients, ages 9 to 58, with moderate to severe acne vulgaris. For 12 weeks, patients used either Altreno or a vehicle. Altreno is a 0.05% formulation of active ingredient tretinoin.

Altreno outperformed vehicle treatment in the trials' primary goal: statistically significant lesion count reductions at 12 weeks. Inflammatory lesions were reduced by 52.1% in Altreno-treated patients, compared to only 41% in vehicle-treated patients. Noninflammatory lesions were reduced by 46.1% in Altreno-treated patients, compared to only 29.9% in vehicle-treated patients.

Additionally, 17.7% of patients who used Altreno achieved clear or almost clear skin, while only 9.3% of patients who used vehicle treatment did.

Altreno also delivered significantly greater patient satisfaction compared to vehicle treatment. Bausch Health said 9 out of 10 patients were satisfied with Altreno a 53% increase from baseline, compared to just a 43% increase in vehicle-treated patients.

Bausch Health said Altreno was well-tolerated in the trials, with site pain, dryness and erythema reported as the most common adverse reactions.

The company presented the data with its dermatology unit Ortho Dermatologics Inc. The findings were published in the Journal of Drugs in Dermatology.

"We believe these new data further demonstrate the value that Altreno provides patients with acne vulgaris, and we look forward to bringing the product to market by the end of the month," Ortho Dermatologics President Bill Humphries said in a news release.

The U.S. Food and Drug Administration approved Bausch Health's new drug application for Altreno on Aug. 24. The Canadian drug developer changed its name from Valeant Pharmaceuticals International Inc. in July.