Galderma presented data supporting its aesthetics portfolio and pipeline at the virtual American Society for Dermatologic Surgery (ASDS) 2021 Meeting. Eight abstracts from investigator-initiated and Galderma-sponsored trials were accepted, including one oral presentation of a hyaluronic acid (HA) filler safety abstract. "We are excited to share new data as part of our commitment to advancing dermatology and aesthetics," says Carrie Caulkins, vice president, U.S. Aesthetics Marketing at Galderma. "Our participation and inclusion in ASDS this year underscores our continued focus on delivering safe and effective products for aesthetic professionals and their patients."
Joel L. Cohen, M.D., board-certified dermatologist, fellowship-trained in aesthetic dermatology, and Galderma clinical trial investigator; presented the compilation of HA filler safety data in a presentation. Using reports from the Manufacturer and User Facility Device Experience (MAUDE) database, the surveillance study analyzed delayed-onset (≥14 days) adverse events of interest (inflammatory and non-inflammatory nodules, hypersensitivity, granulomas) for HA fillers FDA-approved between 2016-2020. While reports of delayed-onset nodules and inflammatory events were uncommon in clinical practice, a retrospective review of reports from the MAUDE database found the rate of occurrence to be low among products formulated with Galderma's unique manufacturing process, XpresHAn Technology. "The study data showcases Galderma's dedication to creating treatments with patient safety in mind," says Cohen. "Compared to other HA fillers in the MAUDE database, the newer members of the Galderma portfolio formulated with XpresHAn Technology, Restylane Defyne, Restylane Refyne and Restylane Kysse had a lower percentage of delayed adverse events of interest."
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