ACKNOWLEDGEMENTS Study funded by and poster/editorial support provided by Galderma Laboratories, L.P., Fort Worth, TX A COMPREHENSIVE ANALYSIS OF THE SAFETY OF A NEW RANGE OF INJECTABLE HYALURONIC ACID PRODUCTS FOR AESTHETIC INDICATIONS David Bank, MD1; Derek H. Jones, MD2; Cindy Wong, MD*3; Jay H. Mashburn, PhD4 1Assistant Clinical Professor of Dermatology, Columbia Presbyterian Medical Center and Director, The Center for Dermatology Cosmetic and Laser Surgery, Mount Kisco, NY; 2Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA; 3Galderma, Uppsala, Sweden; 4Galderma Laboratories, L.P., Fort Worth, TX RES.P-MA10367-09 *Employee of Galderma Laboratories, L.P. at time of poster development INTRODUCTION This review concerns the post-market safety experience of a range of hyaluronic acid (HA) fillers developed by Q-Med AB (Uppsala, Sweden), using Optimal Balance Technology (OBT)TM, known as XpresHAn TechnologyTM in the US (Table 1).1 Almost 1 million units were sold (ex-US) during the first 5 years on the market; this volume and duration of use allows for a thorough and accurate evaluation of the safety of these products to be conducted.2 SUBJECTS and METHODS Data Collection: • The safety dataset was compiled from post-market surveillance (PMS) reports of adverse events (AEs) received since the products were launched in 2011, including any cases reported in the literature • A total of 302 PMS case reports were included in the analysis • Available safety data obtained from sponsored clinical studies were also collected and reviewed Data Analysis: • Reporting frequencies for PMS reports were calculated based on the number of units of product sold and on the assumption that 1 unit was used per treatment • AEs classified as related to treatment or as unassessable were considered to be potentially related AEs and were included in the analysis - Potentially related adverse events with similar or associated preferred terms were grouped. RESULTS • PMS case reports: Of the total number of AEs (from 302 case reports), 771 were classified as potentially related. - Overall reporting frequency: 0.033% for the period of 2011 to 2015, within a range between 0.026 to 0.035% per year - Five most common events were: swelling (0.016%), mass/induration (0.011%), pain and tenderness (0.007%), erythema (0.006%), and papules/nodules (0.006%) - The rare reports of delayed onset events of nodules, swelling or inflammation responded to corticosteroids or hyaluronidase - Ten cases were reported as serious (ie, ischemia with or without necrosis, infection, swelling and nodules) • PMS case reports, continued - Time to onset provided for 483 (63%) of the events · 68% of AEs had a time to onset within 28 days after treatment, 77% within 60 days, and 90% within 120 days - Duration was available for 10% of events · Among these events, 85% resolved within 28 days and 95% within 60 days - Information on the event outcome showed that 64% were resolved or resolving, but no information was available for 25% of these events • Reporting frequencies of nodules, inflammatory reactions and granulomas for OBT HA (Table 2) • Safety data from 7 sponsored interventional clinical studies and 1 observational study were reviewed - Studies; 638 subjects followed for 24 weeks to 18 months · No related serious adverse events adverse events reported · AEs on 3 or more occasions in the entire study population: erythema, hematoma, swelling, pain, papules and telangiectasia · Other events reported with lower occurrences were edema, induration, inflammation, pruritus, dermatitis, and skin tightness • The Emervel French survey, a prospective real-practice descriptive study of 1,822 patients treated with multiple products over 15 months3 - No SAEs reported - Immediate post-treatment assessment showed good local tolerability REFERENCES 1. Segura S, Anthonioz L, Fuchez F, et al. A complete range of hyaluronic acid filler with distinctive physical properties specifically designed for optimal tissue adaptations. J Drugs Dermatol. 2012 Jan;11(1 Suppl):s5-s8. 2. Data on file, Galderma Laboratories, L.P. 3. Farhi D, Trevidic P, Kestemont P, et al. The emervel french survey: a prospective real-practice descriptive study of 1,822 patients treated for facial rejuvenation with a new hyaluronic acid filler. J Drugs Dermatol. 2013 May;12(5):e88-e93. 4. FDA Maude database. SUMMARY ■ There is now a 5-year safety experience to give confidence for use of the OBT range (known as XpresHAn TechnologyTM in the US) of HA fillers ■ There are no new unexpected AEs compared to other established fillers on the market ■ Late onset-AEs that are difficult to treat are very rare ■ The insight gained from real-world practice is that the use of hyaluronidase with or without corticosteroids can treat rare events such as granulomas, delayed onset nodules, and swelling Table 1. Hyaluronic Acid-Based Injectable Filler Product Range: Original and Rebranded Names New Name Original Name Unit Volumes Restylane® Refyne Emervel Classic Lidocaine 1 mL Restylane® Defyne Emervel Deep Lidocaine 1 mL Restylane® Kysse Emervel Lips Lidocaine 1 mL Restylane® Volyme Emervel Volume Lidocaine 1 mL 2 mL Restylane® Fynesse Emervel Touch 1 mL Adverse Events Emervel (OBT HA)2,4 Reporting rate (%), (n = 922,594) Jan 1, 2011 to Dec 31, 2015 Swelling/Edema 0.0163 Inflammatory reaction 0.003 Papules/Nodules 0.006 Granuloma 0.00043 Hypersensitivity 0.001 Ischemia/Necrosis 0.001 Table 2. Reporting Frequencies of Selected Adverse Events Table 3. Adverse Events Reported After 28 Days2,4 Adverse Events Number Typical Outcome if Available Granuloma 5 Typically resolved with hyaluronidase monotherapy or combination therapy Nodules 13 Typically resolved with hyaluronidase monotherapy or combination therapy Swelling with or without inflammation 6 Typically resolved with hyaluronidase monotherapy or combination therapy Swelling preceded by infective episode 4 Recovered after antibiotics FC17PosterGaldermaBankComprehensiveAnalysisNewRange.pdf