Galderma Announces Positive US Pivotal Interim 6-Month Results for EMERVEL Classic Lidocaine Compared to Juvederm Ultra
LAUSANNE, Switzerland--(BUSINESS WIRE)--Oct 20, 2011 - Galderma Pharma S.A., today announced positive interim 6-month results from an ongoing U.S. pivotal clinical study investigating the safety and efficacy of EMERVEL Classic Lidocaine compared to Juvederm Ultra in the treatment of moderate to severe nasolabial folds. Results from this multi-center, evaluator-blinded and randomized split-face comparative clinical study, which evaluated 170 subjects, demonstrated that, at Week 24, EMERVEL Classic Lidocaine was non-inferior to Juvederm Ultra in terms of efficacy. Both products showed a comparable safety profile. EMERVEL Classic Lidocaine presented a favorable pain score profile. The benefit of pre-incorporated lidocaine in EMERVEL was observed rapidly at the time of injection and the pain relief persisted during the 60 minutes of post-injection follow-up.
"As a principal study investigator for the study I found this HA filler to be easy to inject and control and robust in its character to lift,” says Gary D. Monheit, MD and Associate Clinical at University of Alabama at Birmingham. “Due to its unique character of excellent filling at multiple levels plus its soft and natural feel it will be a major contribution in our cosmetic toolbox for facial rejuvenation. The patients tolerated this procedure well due to the lidocaine with little side effects and good results."
These 6-month interim results and the final 12-month results will be subject to further review and future publication in the appropriate medical journal, as well as presentation at future medical conferences. The 6-month data were analyzed by an independent team to protect the integrity of the study and data.
EMERVEL is a complete range of five scientifically-advanced and clinically-proven hyaluronic acid dermal fillers including four fillers containing the widely-used anaesthetic lidocaine. Indicated for the treatment of facial lines, lips, contouring and volume loss, the EMERVEL range of fillers carries the Medical Device CE mark 0459. EMERVEL benefits from Optimal Balance TechnologyTM.
Thanks to this manufacturing engineering innovation, each of the EMERVEL fillers possesses the optimal balance between the degree of cross-linking and gel calibration, articulated around a constant hyaluronic acid concentration of 20 mg/mL.
The different variations of the gel calibration and different degrees of cross linking around this constant hyaluronic acid concentration gives way to the optimal gel texture of EMERVEL.
This allows a suitable integration of the gel into the appropriate skin layer, thus enabling the desired aesthetic effect.
As a result, EMERVEL fillers provide excellent combination of immediate and long-lasting aesthetic correction and tolerance whatever the depth, area and volume correction as shown in the previous and current clinical studies.
EMERVEL is part of the aesthetic & corrective portfolio that enables individual beauty by offering an expanding product range to meet the needs from restoring to improving skin's quality and appearance. The portfolio brings together science-based solutions in dermatology with the heritage of innovative world-renowned aesthetic technology.
Galderma's ambition is to be recognized as the most competent and successful innovation-based company focused exclusively on meeting the needs of dermatology patients and physicians. A fully-integrated specialty pharmaceutical company, Galderma was founded in 1981 and has nearly 4000 employees (of which 560 are Q-Med employees) in 31 affiliates around the world. In March 2011
Q-Med became a part of Galderma. Q-Med is a global leader in the aesthetic market and develops innovative products for aesthetic, corrective and hospital use. With approximately 20% of sales invested each year to discover and develop new products and access innovative technologies, Galderma's laboratory in Sophia-Antipolis, France, is one of the largest R&D facilities in the world dedicated exclusively to dermatology, now complemented by a state-of-the-art R&D center in Uppsala, Sweden. The company's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence. Strategic brands include Epiduo, Oracea, Clobex, Differin, Rozex/MetroGel, Silkis/Vectical, Cetaphil, Loceryl, Tri-Luma, Metvix, Azzalure, Dysport, Restylane, Macrolane and Emervel.
*Dysport is a brand of Ipsen
Posted: October 2011