Ortho Dermatologics Announces Statistically Significant Topline Results From Second Pivotal Phase 3 Clinical Trial Evaluating IDP-126 Gel In Acne Vulgaris

 
 

  All Three Co-Primary Endpoints Were Achieved  

 

- Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced statistically significant topline results from a second pivotal Phase 3 clinical trial evaluating its investigational medicine IDP-126, a combination retinoid, anti-bacterial and antibiotic topical, to treat acne vulgaris in patients nine years of age and older. If approved, IDP-126 would be the first-in-class with this triple combination.

 

Acne is the most common skin problem in the United States , affecting up to 50 million Americans. 1,2

 

The second Phase 3 study confirmed the findings of the first Phase 3 study, which met all of its co-primary endpoints. This second Phase 3 study achieved all three co-primary endpoints at week 12 with statistical significance, including:

 

  • Absolute change from baseline in inflammatory lesion count

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Bausch Health Companies Inc.

Bausch Health Companies Inc.

Formerly known as Valeant Pharmaceuticals, Bausch Health is a global specialty pharmaceutical, consumer health, and medical device company with a focus on branded products for the dermatology, gastrointestinal, and ophthalmology markets. The company reports revenue in five segments: Bausch+Lomb (45% of revenue), Salix Pharmaceuticals (24%), international pharma (14%), ortho dermatology (7%), and diversified products (10%). Bausch is the market leader in consumer visioncare in India and China and the fourth-largest visioncare company by sales in the United States.

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