Recent Developments

FDA Clears CellFX System for the Treatment of SH

The FDA granted Pulse Bioscience’s CellFX System 510(k) marketing clearance for the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-II.

This specific indication clearance enhances the CellFX System’s general indication FDA clearance and enables the company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.

The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.

“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” says Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences, in a news release. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”

Ortho Dermatologics Names 2022 Aspire Higher Scholarship Recipients

Bausch Health Companies, Inc. and its dermatology business, Ortho Dermatologics, recently named the recipients of their 2022 Aspire Higher Scholarship program. The program, which has provided a total of $918,000 in scholarships since launching in 2013, will award nine students who have been treated for a dermatologic condition with a scholarship of up to $10,000 to pursue their undergraduate or graduate degrees.

“For 9 years, Ortho Dermatologics and our Aspire Higher Scholarship program have supported approximately 70 students who have been affected by dermatologic conditions by helping them achieve their higher education goals,” says Richard Lajoie, vice president and general manager, Ortho Dermatologics, in a news release. “We are proud to continue that support with the 2022 Aspire Higher Scholarship recipients who have inspired us with their personal stories. We are truly honored to have the opportunity to help them pursue their academic aspirations through this scholarship, and we also thank the health care providers who had a critical hand in helping to treat their conditions.”

The 2022 honorees were chosen from nearly 200 applications and were selected in part due to their essays that provided an overview of their educational journeys while living with dermatologic conditions and the role a health care professional played in treating the condition. The program recognizes students nationwide across a wide range of educational pursuits, with scholarships in three categories, including the Undergraduate Scholar Awards, the Graduate Scholar Awards and the Today’s Woman Scholar Awards for mothers pursuing undergraduate or graduate degrees.

“For years, I struggled with a skin condition that had a challenging impact on my life and confidence. When added to the responsibilities of being a mother, student and holding a part time job, it made life difficult at times. I am appreciative of Ortho Dermatologics and the support they are providing me through this scholarship, which is helping to bring me one step closer to achieving my goal of becoming a lawyer,” says Kenya Dilday, CUNY School of Law, New York.

Two New Studies Highlight the Efficacy and Safety Profile of Revance’s Daxxify

Glabellar injection of Daxxify (DaxibotulinumtoxinA, Revance) show a positive effect on eyebrow position and a high response rate and duration of effect ≥24 weeks across all age and race subgroups, according to two new studies in the Aesthetic Surgery Journal. 

The first publication evaluated the impact of glabellar injection of Daxxify on eyebrow position and frontalis activity. A post-hoc analysis of patients from the Phase 2a FHL and SAKURA OLS studies, who received a single dose of Daxxify 40 Units to the glabella, showed a positive reduction in dynamic frontalis activity while maintaining or slightly lifting the eyebrows. Two weeks after treatment with Daxxify in glabellar lines, mild eyebrow elevation (at rest) was observed in the lateral, mid and medial brow regions. Further, a reduction in forehead skin compression (reflective of a reduction in frontalis muscle activity) was observed two weeks post Daxxify injection in glabellar lines with the greatest reduction in activity in the lower half of the frontalis.

A separate publication evaluated the efficacy and safety of Daxxify in the treatment of glabellar lines across age and race based on a subgroup- analysis of patients treated in the Phase 3 SAKURA clinical program. Here Daxxify demonstrated long-lasting efficacy in all subgroups, consistent with the overall population results of the SAKURA clinical trials. The analysis included 2,785 patients with moderate to severe glabellar lines who received their first dose of Daxxify (40 Units) in SAKURA 1, 2, or 3 and were evaluated for glabellar line severity for ≤36 weeks. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black/African American, and White).

The proportion of patients achieving none or mild glabellar line severity at maximum frown based on Investigator Global Assessment–Frown Wrinkle Severity (IGA-FWS) rating after Daxxify treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and Patient Frown Wrinkle Severity (PFWS) rating was maintained for a median of 24.0 weeks in all age subgroups, and 27.0, 25.3, and 24.0 weeks in the Asian, Black/African American, and White subgroups, respectively.

The safety profile of Daxxify was consistent across the three main age (18-45, >45-55, and >55 years) and race subgroups, with headache and injection site reactions being the most commonly reported treatment-related treatment emergent adverse events (TEAEs) and treatment-related eyelid ptosis being reported in <2% of patients.

Read more about the FDA approval of Daxxify here.

Can Honey Help Wound Healing?

Honey may play a role in wound healing due to its antimicrobial and tissue-regenerative properties, according to scientists from the University of Manchester.

Their review of more than 250 articles spans 85 years with the oldest article from 1937 and is published in the journal Pharmaceutics.

 The sweet substance may offer an alternative to conventional antimicrobial drugs which are increasingly becoming ineffective in the face of growing resistance.

 However, more work is needed to identify and quantify the compounds that give honey its antimicrobial and wound healing properties to make it more reliable and standardized, the researchers conclude.

 Honey has been mainly used as a topical application on wounds for its antibacterial properties, resulting from its ability to generate hydrogen peroxide and the presence of other active compounds. The compounds include phenols, defensin-1, and methylglyoxal (found in manuka honey). Its acidity and low water availability also contribute to honey’s healing properties. Honey’s stickiness also provides an effective hydrated barrier between the wound site and external environment.

A variety of wound types have been treated with honey, such as burns, trauma, and chronic wounds.

Mesitran, one of the first line of products to incorporate medical grade honey in the UK, was launched in 2005 in Manchester.  In recent years, research has focused on using honey in tissue engineering applications.

Things like electrospun nanofibres, hydrogels and cryogels, foams, films, powders, cements, and bioinks have been utilised to fabricate honey-based scaffolds.  Moreover, some studies have shown how antibiotic-resistant bacteria can be more susceptible to antibiotics when used in tandem with honey.

In one paper included in the review, Methicillin-resistant Staphylococcus aureus (MRSA) was exposed to manuka honey in combination with oxacillin, and they acted together to desensitise the MRSA to the antibiotic.

 Honey’s antimicrobial activity also includes the ability to kill or slow the spread of fungi and viruses.

 Honey in combination with traditional wound dressings presents some limitations, such as being absorbed by the dressing, poor penetration into the wound site, and short-term antimicrobial action, the researchers note.

 However, manufacturers of impregnated dressings are attempting to improve their delivery mechanism to improve the efficacy of the substance.

 “Honey has exciting antimicrobial properties and has been used in traditional medicine to treat wounds since ancient times,” says lead scientist Joel Yupanqui Mieles, a postgraduate researcher from The University of Manchester in Manchester, UK, in a news release.

“The ancient Egyptians utilized it to treat wounds and there are direct references to honey consumption in the Bible and the Quran, [and] the compounds in honey offer a bank of potential antimicrobial and regenerative agents that can be utilized to combat antibiotic resistance and aid in tissue healing,” he says.

 “But though the repository of compounds within honey may have immense medical benefit, further research is required to understand more about how they work and how they can be delivered to wounds effectively and safely in a standardized way,” he says.  “Knowing the type and composition of honey used in different wound types will also improve the quality of research [and] allow scientists to make the most of honey’s antimicrobial and healing mechanisms.”

 This work may allow researchers to artificially replicate these in honey-inspired biomaterials that can be used with the current advances in tissue engineering technologies. “That would minimize risks around processing in terms sterilization, storage, transport and determining authenticity and safety,” he says. “One thing is certain: rising global antibiotic resistance is stimulating the development of novel therapies as alternatives to combat infections – and honey, we think, has a role to play in that.”

CHMP Recommends Adtralza (tralokinumab) for the Treatment of Adolescents With Moderate to Severe AD

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending extending the approval of LEO Pharma’s Adtralza (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 

The recommended dose for adolescent patients is an initial dose of 600mg followed by 300mg administered every other week, which is the same dosing as for adult patients.

Adtralza, a high-affinity human monoclonal antibody, is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It also is approved for adults in the United States under the tradename Adbry. It is not currently approved in any market for adolescent use.

The CHMP opinion is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate to severe AD who were candidates for systemic therapy. Primary endpoints in the trials were the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).

Secondary endpoints were measured by extent and severity of atopic dermatitis (SCORAD), at least a 4-point improvement in adolescent weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) score, and Children’s Dermatology Life Quality Index (CDLQI) score.

The CHMP’s positive opinion will be reviewed by the European Commission (EC) and pending the final decision, the marketing authorization will be valid in all EU Member States, Iceland, Norway, and Liechtenstein. An additional regulatory filing is underway with the FDA.

Positive Dupixent Phase 3 Data in Children Aged 6 Months to 5 Years with Moderate to Severe AD

Dupixent (dupilumab, Sanofi Regeneron) significantly improved skin clearance, and reduced itch and overall disease severity in children as young as 6 months old, according to a new Phase 3 trial in the Lancet.

These data were the basis for the FDA approval of Dupixent in June 2022 and for a regulatory submission currently under review by the European Medicines Agency.

Data from this trial showed that adding Dupixent to low-potency topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch compared to TCS alone (placebo) at 16 weeks. Additionally, Dupixent patients experienced significant improvement in measures of sleep quality and skin pain, as well as patient- or caregiver-reported outcomes and health-related quality of life. A substantially lower proportion of Dupixent patients needed rescue medications, compared to those on placebo.

Safety results through 16 weeks were similar to the safety profile in patients 6 years and older with atopic dermatitis. Adverse events that were more commonly observed with Dupixent (≥5%) included conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo), molluscum contagiosum (5% Dupixent, 3% placebo), rhinorrhea (5% Dupixent, 1% placebo) and dental caries (5% Dupixent, 0% placebo).  

The safety and efficacy of Dupixent in children 6 months to 5 years of age with uncontrolled atopic dermatitis has not been fully evaluated by any regulatory authority outside the US.

The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone in 162 children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. Patients treated with Dupixent received either 200 mg or 300 mg (based on weight) every 4 weeks. 

The primary endpoints assessed the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and at least a 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16.

Phase 3 Trial Assesses Roflumilast Foam in Scalp and Body Psoriasis

Topline results from the ARRECTOR Pivotal Phase 3 trial evaluating Arcutis Biotherapeutics, Inc.’s roflumilast foam 0.3% (Zoryve) were positive for the treatment of adults and adolescents with scalp and body psoriasis. The study met its co-primary endpoints of S-IGA Success and B-IGA Success, and all secondary endpoints.

Specifically, 67.3% of individuals treated with roflumilast foam, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, achieved S-IGA Success compared to 28.1% of individuals treated with a matching vehicle foam at week 8 (P<0.0001), and 46.5% of individuals treated with roflumilast foam achieved B-IGA Success compared to 20.8% of individuals treated with a matching vehicle foam at week 8 (P<0.0001). Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints, including scalp itch as measured by Scalp Itch Numeric Rating Scale (SI-NRS) and overall itch as measured by Worst Itch NRS (WI-NRS) at week eight.

Plaque psoriasis impacts 9 million people in the United States and approximately 40% of individuals have involvement of the scalp. Scalp psoriasis can have a significant negative impact on quality of life, with individuals feeling shame, embarrassment, or self-consciousness as a result of their scalp disease. Today, scalp psoriasis is most often treated with topical therapies, including corticosteroids and vitamin D analogs, which come with trade-offs between efficacy, tolerability, and long-term usability. Roflumilast foam is a selective and potent PDE4 inhibitor that has been uniquely formulated as an emollient, water-based, moisturizing foam that can be used on the scalp and body.

Roflumilast foam was well-tolerated, and the overall safety and tolerability profile was consistent with previously published studies of roflumilast cream 0.3% and foam. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse events in the study population included headache, diarrhea, and COVID-19. In the study, 89.0% of patients who were randomized to roflumilast foam completed the full eight weeks, and few subjects discontinued study drug due to adverse events (2.5% and 1.3% in the roflumilast foam and vehicle groups, respectively).

The company plans to submit a New Drug Application (NDA) to the FDA for roflumilast foam for the treatment of seborrheic dermatitis in Q1 of 2023. The Company believes that the positive results from the ARRECTOR study should provide sufficient bases for a supplemental NDA.

Unravelling the Role of Demodex in Rosacea

Researchers have long observed that microscopic mites that live as scavengers on normal human skin tend to occur in greater numbers on the faces of rosacea patients. It was unknown, however, whether the higher density of these Demodex, was a cause or an effect of this widespread disease.

Now there is mounting evidence that this phenomenon may play a potential role in the development of the papules and pustules often associated with the disorder, according to an analysis of research data recently published by Dr. Fabrienne Forton in Belguim.

She noted that recent studies suggest Demodex triggers two opposite actions: first, a normal immune response aimed at eliminating the mite and, secondly, an immunosuppressive action aimed at favoring its proliferation. During this process, T-cells in the skin are exhausted, which allows the dominance of immunosuppression, including the production of vascular endothelial growth factor (VEGF). This results in an altered vascular environment where the mites can flourish as a co-factor in the occurrence and severity of inflammatory lesions. Dr. Forton also cited research that suggests persistent erythema may provide a favorable breeding ground for the mites, which may in turn worsen rosacea symptoms.

In the new National Rosacea Society (NRS) standard classification of rosacea based on advanced scientific knowledge, the disease is now understood as a single disorder with many potential clinical features, or phenotypes, that may occur in various combinations. Persistent erythema is identified as the primary diagnostic sign. Phymatous changes, especially around the nose, are also considered diagnostic, although less common.

In addition, major signs of rosacea include papules and pustules, flushing, visible telangiectasia and ocular rosacea. The presence of any two of the major phenotypes may be considered diagnostic of rosacea, and secondary phenotypes include burning, stinging, edema, and dryness.

Although these signs and symptoms may appear at different times and in varying combinations, studies indicate they may all be manifestations of the same underlying inflammatory continuum.

“Growing knowledge of rosacea’s pathophysiology has established that a consistent multivariate disease process underlies its potential manifestations, and the clinical significance of each of these elements is increasing as more is understood,” says Dr. Richard Gallo, chairman of dermatology at the University of California, San Diego, who chaired the National Rosacea Society (NRS) Expert Committee in the development of the new classification system, in a news release. “Although the potential role of Demodex in rosacea has been controversial in the past, these new insights suggest where it may play a role as a meaningful co-factor in the development of the disorder.”

CLOSE UP with Jacob Thyssen, MD, PhD, DmSci

New therapies are changing the way that atopic dermatitis is treated, but an unmet need remains. Here, Jacob Thyssen, MD, PhD, DmSci, a professor at the University of Copenhagen and a dermatologist at Bispebjerg Hospital in Denmark, discusses the latest data on Eli Lilly and Company’s investigational iinterleukin-13 blocker lebrikizumab. The findings were presented at the 31st EADV Congress in Milan, Italy.

Why is this topic important to study?

Dr. Thyssen: Atopic dermatitis (AD) is a highly prevalent dermatological disease, with symptoms that include itching, dry skin, severe pain, and inflammation, all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. The treatment landscape in AD has evolved dramatically in the past five through six years. It all started with the approval of the first biologic in 2017 and has been followed by the approval of other drugs, including one biologic and three oral drugs in the past one to two years. Despite this, there are still remaining unmet needs in moderate to severe AD, mainly around getting robust efficacy over time without safety tradeoffs and better convenience regimens. Thus, we continue to work to have more treatment options that help us address those unmet needs. 

Describe the research and your findings.

Dr. Thyssen: Lebrikizumab, a monoclonal antibody that inhibits an interleukin named IL-13, is in development for moderate to severe AD. For the first time we have reported week 16 and week 52 data of its phase 3 trials. Week 16 data is the short-term data, while week 52 data is maintenance data. The week 16 data of lebrikizumab was made public in March 2022 and points toward a drug with robust efficacy and a good safety profile. The week 52 data that was reported at European Dermatology Congress in Milan confirms the maintenance of response of lebrikizumab until week 52 with both doses: lebrikizumab administered only once a month (Q4W) and lebrikizumab administered 2 times a month (Q2W).  Taken together, these results confirm that IL-13 is a key cytokine in the pathogenesis of AD and are very encouraging for both dermatologists and patients because suggest that effective IL-13-specific inhibition has the potential to improve AD management in the coming years.

What is the next step?

Dr. Thyssen: Among the next steps, full results from the different Phase 3 studies will be published in peer-reviewed journals. In parallel, Almirall and Lilly plan to submit regulatory applications to European Medicines Agency and FDA respectively for lebrikizumab in moderate to severe AD in adults and adolescents this year.

Midmark Trade-in Program Helps World Vision

Midmark Corp.’s 2021 trade-in program collected 1,000 eligible exam tables. The tables were donated primarily to World Vision, where they are refurbished and delivered to clinics that provide health care to children and families in remote areas of developing countries. The donation, valued at approximately $500,000, is the largest one-time donation of tables from Midmark’s trade-in program.

“At Midmark, we believe that all patients deserve accessible, quality healthcare and are committed to doing our part to make this happen,” says Kurt Forsthoefel, director of medical marketing, Midmark. “Through our unique trade-in program and our longstanding relationship with World Vision, Midmark is helping provide better care and improve medical services that impact lives around the world.”

As part of its trade-in program, Midmark offers customers rebates on eligible products purchased with a valid equipment trade-in. Eligible products purchased include Midmark IQecg, Midmark HEINE diagnostic instruments and Midmark Barrier-Free exam chairs. Midmark has donated approximately 10,000 tables to World Vision since the beginning of its relationship with the organization in 2005. These tables have been given to clinics all around the world, including in Ghana, Nicaragua, Zambia and Burundi.

“We value our relationship with Midmark and appreciate everything the company and its teammates do to help ensure the equipment continues to play a role in providing quality care to those in need,” says Jack Laverty, director of corporate engagement, World Vision. “This year’s donation was especially challenging given the logistical constraints being felt around the globe. Midmark and its customers really stepped up, covering freight charges and donating labor to help the equipment get to where it needed to be.”

Along with increasing access to quality care in remote areas, there is also a sustainability benefit to this year’s donation of 1,000 exam tables. Each exam table weighs about 400 pounds, which means 200 tons of equipment was saved from being placed in landfills.

World Vision is a Christian humanitarian organization dedicated to working with children, families and their communities worldwide to reach their full potential by tackling the causes of poverty and injustice. With staff in nearly 100 countries, World Vision serves all people, regardless of religion, race, ethnicity or gender.

Almirall’s Tildrakizumab Improves Sleep in People Living with Psoriasis

During the 31st EADV (European Association of Dermatology and Venereology) Congress, Almirall S.A shared results from TRIBUTE, an interventional phase IV clinical study that resembled real-life clinical practice. In this study, Ilumetri (tildrakizumab) is the first IL-23p19 inhibitor to demonstrate improvement on sleep impairment in patients with moderate-to-severe chronic plaque psoriasis. At week 24, the MOS-Sleep (Medical Outcomes Study-Sleep) index II showed a statistically significant and clinically relevant benefit, with a score close to population norm.

After 24 weeks of treatment with tildrakizumab, 76.5% and 84.9% of patients reported mild itch and pain, respectively. Significant improvement in scaling was also demonstrated in the TRIBUTE study. These benefits on burdensome symptoms were accompanied by high levels of treatment satisfaction, and 70.4% of patients had no impairment on health-related quality of life.

The TRIBUTE study confirms the effectiveness of tildrakizumab with two thirds of patients achieving a psoriasis area and severity score of less than 1 after 24 weeks. And tildrakizumab demonstrated a favorable safety profile similar to that seen in Phase 3 trials.

Approximately 60 million people live with psoriasis worldwide. This skin condition disrupts every aspect of patients’ daily lives: from sleep, clothing choices, and exercise, to work and social life, preventing them from the possibility of leading a normal daily life. Although 88% of the patients affirm that the condition affects their overall emotional wellbeing, the impact of psoriasis on physical, social, and psychological wellbeing is often underestimated.  

“At Almirall, we go beyond studying and treating the physical symptoms of psoriasis. We strive to gain an individual understanding of the obstacles faced by a person living with psoriasis and the impact it has on their daily lives. Studies close to clinical practice, such as TRIBUTE, and other real-world evidence research presented at the EADV Congress, help us understand and measure how tildrakizumab delivers benefits to a wide range of patients” says Volker Koscielny, Chief Medical Officer of Almirall, in a news release.

Almirall presented 12 tildrakizumab posters at the 31st EADV Congress. In addition to TRIBUTE, the company showcased long-term data from the large, non-interventional, prospective TILOT study. Tildrakizumab demonstrated significant and sustained efficacy, high treatment satisfaction and a favourable safety profile in a real-world setting with similar results in both bio-experienced and bio-naïve patients.

Pooled analyses from the Phase 3 trials reSURFACE 1 and reSURFACE 2 over 5 years, also presented in the congress, indicate that tildrakizumab provides long-term disease control across a wide range of patient characteristics(e.g. previous biological therapy, type 2 diabetes and psychiatric disorders).