FDA Approves Dermavant’s Vtama for Psoriasis
FDA has approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist from Dermavant, for the topical treatment of plaque psoriasis in adults.
“As the first and only approved drug in its class in the US, Vtama cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis and represents a major milestone for Dermavant and its stakeholders,” says Todd Zavodnick, Chief Executive Officer of Dermavant.
“I believe the approval of Vtama cream is an important step in establishing a new treatment option for adults with mild, moderate and severe plaque psoriasis,” says Mark Lebwohl, MD, FAAD, Dean for Clinical Therapeutics and Waldman Professor and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York.
Across PSOARING 1 and PSOARING 2, Vtama cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of “clear” (PGA=0) or “almost clear” (PGA=1) with a minimum two-grade improvement compared with vehicle from baseline at week 12. Vtama cream also demonstrated a highly statistically significant improvement in all secondary endpoints versus vehicle, including ≥75 percent Improvement in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at week 12. The adverse event (AE) profile of Vtama cream reported in both PSOARING 1 and PSOARING 2 demonstrated that the majority of AEs were localized to the site of application and were mild to moderate in nature.
More than 40 percent of Phase 3 long-term extension (LTE) study patients (n=312/763) achieved complete disease clearance (PGA=0) at least once during the study period. For patients randomized to Vtama cream in PSOARING 1 and PSOARING 2 who achieved a PGA of 0 during the 12-week study and subsequently enrolled in the Phase 3 LTE study (n=73), Vtama cream demonstrated a remittive effect (maintenance of PGA of 0 or 1 while off therapy) with a median duration to first worsening of approximately four months. Among a larger cohort of patients who either entered the Phase 3 LTE study with a PGA score of 0 or achieved one during the LTE study (n=312), the mean duration of remittive effect off-therapy was 130 days.
In the Phase 3 LTE study, Vtama cream demonstrated safety and tolerability consistent with PSOARING 1 and PSOARING 2. Treatment emergent adverse events were mostly mild to moderate in nature and restricted to application sites.
In September 2021, Dermavant Sciences dosed its first patient in a Phase 3, double-blind, vehicle-controlled study of tapinarof cream for the treatment of atopic dermatitis (AD) in adults and children. The Phase 3 clinical program will enroll up to 800 patients across two pivotal trials (ADORING 1 and ADORING 2) to evaluate the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older. The company anticipates announcing topline results from ADORING 1 and ADORING 2 in the first half of 2023.
Dr. Paul M. Friedman Begins Role as ASLMS President
Paul M. Friedman, MD is the new President of the American Society for Laser Medicine and Surgery (ASLMS).
Dr. Friedman, board-certified by the American Board of Dermatology, is the director of Dermatology & Laser Surgery Center of Houston, Texas. He is a clinical assistant professor at the University of Texas Medical School, department of dermatology, and a clinical assistant professor of dermatology at the Weill Cornell Medical College, Houston Methodist Hospital. He is also on staff at Texas Children’s Hospital and Memorial-Hermann Hospital-Texas Medical Center.
Dr. Friedman has been recognized as a leading physician and researcher in the field and has also been involved in the development of several new laser systems and therapeutic techniques now commonly used throughout the world. He is passionate about supporting philanthropic causes through his work.
“I am honored to serve as the president of this incredible society. In the coming year, I will be looking to the membership to bring their talents forward to help change lives with lasers,” says Dr. Friedman in a news release. “There are plenty of needs and opportunities. My goal is to bridge the gap and help those patients who desperately need our expertise.“
Dr. Friedman is calling on ASLMS members to expand philanthropic programs that can help change lives with lasers.
“One of my main initiatives in this upcoming year is going to be a philanthropic campaign to create a national directory of board-certified ASLMS members who volunteer their time and devices to remove branding tattoos free of charge to help sex trafficking survivors and their recovery process,” Dr. Friedman says.
In Dr. Friedman’s presentation to the membership, he shared that human trafficking is the second-largest and fastest-growing criminal industry in the world, with up to 300,000 people at risk of being trafficked in the US alone. Many victims of sex trafficking are branded by their traffickers with tattoos conveying ownership, including names, symbols, initials, and barcodes. This problem generates a desperate need for support during recovery for thousands of survivors by providing safe and effective pro bono laser tattoo removal to allow survivors to reclaim their bodies. Not only would tattoo removal be helpful for recovery, it could also provide a unique opportunity to create a repository of sex trafficking tattoo images to help improve identification competency.
An additional initiative will be to work in conjunction with the Vascular Birthmark Foundation to create best practice guidelines for safely treating vascular birthmarks.
“Creation of a consensus of uniform standards for the treatment of vascular birthmarks with laser therapy is well overdue,” says Dr. Friedman. “Members of this prestigious society have developed and optimized the incredible technology that we all utilize on a daily basis. By partnering with organizations like the Vascular Birthmark Foundation, we can offer our expertise and devices to those who would not otherwise be able to afford treatments.”
Research has shown that laser education in residency programs is lacking. Since ASLMS is the top society for laser education, Dr. Friedman will continue to expand access to the educational opportunities available through ASLMS for residents and early career scientists.
Consumer education is also at the forefront of his initiatives this coming year. As patients increasingly use social media for research on cosmetic procedures, consumer education from reputable sources, namely core cosmetic physicians, is imperative. Dr. Friedman believes that the ASLMS can expand its efforts to provide patient education and counteract misinformation regarding cosmetic procedures.
“As an interdisciplinary and international professional society, the American Society for Laser Medicine and Surgery can help foster increased presence by promoting social media collaboration among core cosmetic physicians,” says Dr. Friedman.
Dr. Friedman succeeds Henry H.L. Chan, MD, PhD, FRCP, who now serves as the Society’s Past President. The 2022-23 ASLMS Executive Committee also includes President-Elect Murad Alam, MD, MSCI, MBA; Vice President Arisa E. Ortiz, MD; Secretary Kristen M. Kelly, MD; Treasurer Omar A. Ibrahimi, MD, PhD; and Historian J. Stuart Nelson, MD, PhD.
Other new members of the Board include representatives for:
- Basic Science: Lilit Garibyan, MD, PhD and Thomas E. Milner, PhD
- Industrial/R&D: Brad Hauser
- Laser Medicine: Christopher B. Zachary, MBBS, FRCP
- Laser Safety: H. Ray Jalian, MD
- Laser Surgery: Anne M. Chapas, MD
Also starting their term are two new Student Board Representatives, Early Career Scientist Nitesh Katta, PhD, MSc, BTech and Resident/Fellow Anna-Marie Hosking, MS, MD.
Alleran Aesthetics Launches Allē Flash
Allergan Aesthetics recently introduced Allē Flash, a new intelligent experience available through its Allē consumer loyalty program. With a simple scan of a QR code at any participating provider’s office, four million members on the Allē platform get the chance to be rewarded in real time. Allē Flash delivers relevant treatment offers to members while with their providers. This incentivizes members to act on a treatment of interest with their provider at either the current or future appointment date.
Jasson Gilmore, Co-Founder of Allergan Data Labs, says the company launched the Allē platform at the end of 2020 with the goal of making their loyalty program much more seamless and easy for physicians and patients and to offer points and discounts for Allergan and non-Allergan products to try to drive retention in the market.
“Over 94 percent of our customers cite it as easy to use,” says Mr. Gilmore. “Allē Flash is really just an extension, if you will, of a strategy that we’ve been working toward for several years now to bring more seamless rewards and promotions and access to consumers into aesthetic medicine.”
Allergan Aesthetics gives all providers in its Allē program a unique QR code they can display in their offices for patients to scan when they check in. Once the patient scans the QR code, in real time the Allē algorithm determines their eligibility for any other promotions or products. “This makes having the conversation about other procedures easier for the provider and also lets the consumer see what other treatments they might be able to take advantage of while they’re in the office,” Mr. Gilmore explains.
To learn more about the program and how it benefits aesthetic physicians, visit our sister publication at ModernAesthetics.com to watch “MATV News Extra: The Lowdown on Allergan Allē Flash.”
CLOSE UP with Rebecca Hartman, MD, MPH
Melanoma is the fourth most commonly diagnosed cancer among veterans, but little was known about specific risk factors and stage at diagnosis. Now, a new study of more than 15,000 veterans helps answer these questions. Study author Rebecca Hartman, MD, MPH, an instructor of dermatology at the Brigham and Women’s Hospital in Boston, MA, shares some insights from the research which appears in the Journal of the American Academy of Dermatology.
Why is this topic important to study?
Rebecca Hartman, MD, MPH: Veterans have several risk factors for melanoma, including exposure to ultraviolet and ionizing radiation through their military service as well as demographic features such as older age and male sex. Population-based data about melanoma may not accurately represent the burden of melanoma in veterans. We sought to better understand the burden of melanoma in veterans compared to the general population.
Describe the research and your findings?
Dr. Hartman: We found that veterans were more likely to be diagnosed with advanced melanoma than the general population and had lower melanoma-specific survival across all stages. However, both veterans and the general population experienced improvements in survival for stage IV disease from 2015-to 2017 during the targeted and immunotherapy eras, with veterans having higher stage IV survival during that time period. This finding suggests veterans as well as the general population are benefitting from these novel therapies. Veterans may be obtaining more benefit for a variety of reasons, possibly improved access to treatments through the VA system in addition to better treatment response as data suggests older individuals may respond better to immunotherapy than younger ones.
What is the next step?
Dr. Hartman: We hope to further characterize the melanoma burden and treatment response in veterans to develop personalized strategies for melanoma diagnosis and treatment in this unique patient population.
Crown to Acquire Aesthetic Product Portfolio from Eclipse
Crown Laboratories will acquire the global aesthetics-focused assets of Eclipse. The acquisition expands Crown’s aesthetics’ product portfolio and enhances Crown’s overall value proposition as a global leader in science-based aesthetic skincare solutions.
As an innovative company focused on skin science, Crown will integrate the Eclipse products into the Aesthetics business unit of Crown to complement its SkinPen Precision and other brands. Eclipse customers can expect to continue receiving superior customer service, medical education, and access to Crown›s expanded range of highly effective aesthetic products.
The company also announced that June Risser is the new General Manager of Premium Skincare. She will lead the global business unit which includes StriVectin and Vita Liberata, and she will hold a position on the Executive Leadership Team.
Prior to Crown, she was General Manager at Galderma Laboratories where she led the dermatologist-recommended skin care brands Cetaphil and Differin in the US.
“I am excited to join a purpose-driven company that is committed to skin science for life with great brands, a strong pipeline, and talented team,” says Ms. Risser in a statement. “Crown has a track record of growth and is poised for continued success. I look forward to being part of this winning team.”
Cynosure Upgrades PicoSure System with PicoSure Pro Device
Cynosure is launching the PicoSure Pro device, the latest upgrade to the company’s PicoSure system. An FDA-cleared 755nm picosecond laser, the PicoSure Pro device uniquely delivers energy in a trillionth of a second, utilizing pressure instead of heat to provide safe and effective treatments for unwanted pigmentation and skin revitalization for all skin types.
“As inventors of picosecond aesthetic laser technology, we are constantly challenging ourselves to continually drive innovation forward. Whether we’re developing new devices or improving upon our trusted flagship products, we’re focused on addressing the unmet needs of our practitioners to ensure the best possible outcomes for their patients and practice,” says Todd Tillemans, Chief Executive Officer of Cynosure, in a news release. “From a 50 percent increase in energy to new handpieces and an adjustable fluence, the performance enhancements made to the PicoSure Pro device provide practitioners with more versatility than ever before, allowing them to efficiently treat more patients per day and provide better outcomes in less time.”
The PicoSure Pro device’s advanced Platinum Focus lens array is used to increase collagen and elastin to help combat wrinkles, acne scars and pores. With the addition of the flat lens, the PicoSure Pro device is now also the first and only picosecond laser FDA-cleared for the treatment of pigment in melasma and other hyperpigmentation issues such as nevus of Ota and Hori’s nevus. Additional enhancements include a sleek, modern design, intuitive graphic user interface and new 5MM handpiece that is ideal for treating discrete lesions, lighter Fitzpatrick skin types and smaller treatment areas.
Scleroderma Awareness in Focus
June is Scleroderma Awareness Month, and “Know Scleroderma” is the National Scleroderma Foundation’s theme for 2022.
Throughout the month, the Foundation will post videos and photos of individuals affected by scleroderma on its Facebook, Twitter, Instagram, and LinkedIn social media accounts.
The campaign highlights the Foundation’s belief that to know scleroderma is to understand the impact of a rare disease that is life-threatening for many and can cause physical disabilities and change lives forever. Featured in the campaign is recording artist Ashley Barron, who was diagnosed with localized scleroderma at age five, and is the Foundation’s Celebrity Ambassador.
Apyx Medical Corporation Receives FDA 510(k) Clearance for Renuvion Handpiece
The FDA has granted marketing clearance to Apyx Medical Corporation’s Renuvion Dermal Handpiece for specific dermal resurfacing procedures.
The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
Apyx Medical Corporation products include Helium Plasma Technology products marketed and sold as Renuvion and J-Plasma in surgical markets. Renuvion and J-Plasma allow surgeons to provide controlled heat to tissue to achieve their desired results.
