DULUTH, Ga., March 1, 2019 /PRNewswire/ -- Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced new results from its real-world study in Europe evaluating Sebacia Microparticles for treatment of acne. The study demonstrated an average 85% improvement in facial acne at 12 months.
The results were presented at the American Academy of Dermatology (AAD) 2019 Annual Meeting in multiple oral presentations by Jill S. Waibel, MD, board-certified dermatologist practicing at the Miami Dermatology and Laser Institute and a Sebacia U.S. clinical trial investigator, and Arielle N.B. Kauvar, MD, board-certified dermatologist practicing at New York Laser & Skin Care.
The most commonly prescribed first-line acne medication for patients with mild to moderate inflammatory facial acne includes a topical retinoid. In Sebacia's EU registry study, patients were prescribed a 2-4 week course of topical retinoid + benzoyl peroxide (BPO) followed by three weekly in-office treatments of Sebacia Microparticles. Patients stopped the retinoid + BPO after treatment and physicians were directed to manage patients to clinical success, including reintroducing acne medications if desired. The ongoing registry study, which is being conducted at nine non-academic clinical practices in Europe and to date has enrolled 76 patients, demonstrated a clinically significant effect of the combination treatment on long term acne outcomes and acne medication usage.
Key results to date include:
- At 12 months, the mean acne inflammatory lesion count (ILC) improvement was 85% from baseline and 56% of patients were free of acne medications.
- At 6 months, the mean ILC improvement was 74% from baseline, with 70% of patients free of acne medications.
- 67% of patients had an Investigator Global Assessment (IGA) score of clear or almost clear at 12 months, an improvement from 63% of patients at 6 months.
- Only 8% and 14% of patients were prescribed systemic acne medications at 6 and 12 months respectively.
"These data demonstrate the robust, long-term clinical effectiveness of Sebacia Microparticles in acne patients out to a year, supporting the addition of this important topical and localized treatment to our poly-therapeutic approach to managing acne," said Dr. Jill S. Waibel, board-certified dermatologist practicing at the Miami Dermatology and Laser Institute and a Sebacia U.S. clinical trial investigator and a presenter of the 12-month results at the AAD Annual Meeting. "Sebacia Microparticles represents an innovative new in-office treatment for patients with mild to moderate acne, especially as it may help avoid progression to second- and third-line treatments, including systemic acne medications."
Anthony Lando, Chief Executive Officer, added, "We are very pleased with the results of our European real-world study as it will help dermatologists understand how Sebacia Microparticles can be integrated into their treatment algorithm for treating acne. We look forward to engaging with the dermatology community at AAD and making Sebacia Microparticles available to U.S. physicians via our commercial launch in mid-2019."
FDA-cleared Sebacia Microparticles selectively targets the sebaceous (oil-producing) glands to treat acne at the source, offering dermatologists a truly innovative approach to acne therapy. In the U.S., Sebacia Microparticles was cleared in 2018 by the U.S. Food and Drug Administration (FDA) for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.
Sebacia, Inc. is a private medical device and aesthetics company focused on creating advanced topical therapies for the treatment of dermatological conditions, with a primary focus on a novel procedure-based acne treatment. Sebacia's goal is to provide a better alternative to the daily use of topical and systemic drugs currently available for the treatment of acne. Sebacia's patented microparticles technology was invented at Rice University, and the proprietary dermatology applications were further developed with researchers from the Wellman Center of Photomedicine at Massachusetts General Hospital. Sebacia Microparticles is cleared for use in the U.S. and in the EU, the two largest dermatology markets in the world. Sebacia is planning its U.S. commercial launch for mid-2019. In the EU, Sebacia Microparticles is sold in select markets. Investors in the company include Accuitive Medical Ventures, Domain Associates, Partners Innovation Fund, Salem Partners and Versant Ventures.
SOURCE Sebacia, Inc.