Journey Medical Corporation announced positive Phase 3 trial results for its rosacea treatment, Emrosi (DFD-29), published in JAMA Dermatology. The drug, a modified-release minocycline capsule, demonstrated statistically superior efficacy compared to both Oracea (doxycycline) and placebo in reducing inflammatory lesions and erythema. The FDA approved Emrosi in November 2024, with a planned launch in early spring 2025.
This news holds considerable potential to shift the treatment landscape for rosacea. Emrosi’s demonstrated superiority over the current standard of care, Oracea, offers patients a more effective treatment option. The publication of these results in a prestigious journal like JAMA Dermatology adds to the credibility of the findings and may influence dermatologist prescribing patterns. A successful launch could capture a significant share of the existing rosacea market, currently estimated to impact millions of people in the US alone.
In two Phase 3 trials (MVOR-1 and MVOR-2), DFD-29 outperformed both Oracea and placebo on co-primary endpoints of Investigator’s Global Assessment (IGA) treatment success and reduction in inflammatory lesion count. Specifically, in MVOR-1, IGA success rates were 65% for DFD-29, 46.1% for Oracea, and 31.2% for placebo. In MVOR-2, the corresponding rates were 60.1%, 31.4%, and 26.8%, respectively. DFD-29 also demonstrated statistically significant reductions in lesion counts compared to both Oracea and placebo in both studies. Importantly, the safety profile of DFD-29 appeared comparable to existing treatments, with no significant safety concerns reported.
The positive Phase 3 data and FDA approval set the stage for Emrosi’s upcoming launch. Market penetration will depend on factors such as pricing, payer coverage, and clinician acceptance. If Journey Medical effectively communicates Emrosi’s clinical advantages and secures favorable market access, the drug has the potential to become a leading treatment option for rosacea, improving outcomes and quality of life for patients. Furthermore, the success of Emrosi could spur further innovation in the rosacea treatment space, potentially leading to the development of even more effective therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
