Galderma Laboratories has completed two independent Phase 3 clinical trials of CD07805/47, a topical gel under investigation in adults with moderate to severe facial erythema (redness) of rosacea.
Rosacea is a chronic, inflammatory and vascular condition of the face and eyes characterised by persistent erythema, flushing, inflammatory lesions and visible blood vessels.
The two randomised vehicle-controlled multicentre Phase 3 trials demonstrated the efficacy and safety of CD07805/47 applied topically once daily versus vehicle (control) in adult patients with moderate to severe facial erythema of rosacea.
University of Louisville dermatology clinical professor Joseph Fowler said the facial erythema associated with rosacea can have a negative psychosocial impact on patients, giving rise to anxiety and creating low self-confidence and embarrassment.
Galderma Laboratories president Francois Fournier said the company is committed to partnering with healthcare providers to drive innovation and develop treatments for patients with dermatologic conditions.
"These results are encouraging because this investigational treatment has the potential to one day address unmet needs in this highly prevalent condition," Fournier added.
The company plans to submit a New Drug Application for CD07805/47 to the US Food & Drug Administration and to the European Medicines Agency.
Galderma is a global pharmaceutical company that develops a range of therapies for dermatological conditions, including acne, rosacea, onychomycosis, psoriasis and steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.
In 2011, Galderma acquired a Swedish medical device company, Q-Med, strengthening Galderma’s presence in the aesthetic and corrective market.