Recent Developments

Zilxi Approved: First Topical Minocycline Treatment for Rosacea

The FDA has approved Zilxi (minocycline) topical foam, 1.5%, from Menlo Therapeutics for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd., is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

Zilxi is formulated with Menlo’s proprietary Molecule Stabilizing Technology (MST) platform to effectively deliver minocycline in a foam-based vehicle. Menlo expects to have Zilxi available for prescribing by the fourth quarter.

FDA approval is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with Zilxi or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12.

Zilxi met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events were reported.

Cynosure Launches Elite iQ Aesthetic Workstation For Laser Hair Removal, Skin Revitalization

Cynosure is launching the Elite iQ platform—the next generation of Cynosure’s Elite+ Aesthetic Workstation and the first Alexandrite-ND: YAG System to US, European, and Australian markets.

Armed with patented Skintel technology, which measures melanin and reads specific skin types of patients allowing for real-time adjustment of treatments settings, the Elite iQ workstation solves the challenges historically encountered by practitioners when treating men and women with darker skin types.

The Elite iQ device also enables practitioners to treat common skin concerns including unwanted hair, facial and leg veins, sun damage, facial wrinkles and razor bumps, all on a single device without surgery.

“My patients are pleased with their fast and easy laser hair removal sessions thanks to the Elite iQ technology,” says Vic Ross, MD of Scripps Clinic, based in San Diego, CA. “I hear often that women and men with darker skin types were under the impression they weren’t candidates for these types of treatments and the reality is, everyone is a potential candidate I can treat with ease and confidence. The intelligently designed instrument panel, including real-time pigmentation assessment that guides the practitioner in optimal parameter selection, has set my practice apart and has meant even more satisfied patients with fantastic results.”

The next-generation workstation has a new dashboard design and a built-in treatment guide to help determine hair removal test spot settings; dynamic screen lighting to easily view the active wavelength; high treatment versatility with adjustable pulse width, fluence and repetition rate; and the ability to save settings for future use. The upgraded station also includes a sliding drawer accessible from both sides of the device, a flat-top design for easy access to accessories during treatments and it is more easily maneuvered with a new wraparound handle, Cynosure notes.

FDA Approves Dupixent for Children Aged 6 to 11 Years with Moderate to Severe AD

The FDA gave its nod to Dupixent (dupilumab) for children aged six to 11 years with moderate to severe atopic dermatitis (AD).

Dupixent comes in two doses, prescribed based on weight (300mg every four weeks for children ≥15 to <30kg and 200mg every two weeks for children ≥30 to <60kg, following an initial loading dose) as a pre-filled syringe.

The approval is based on data from a pivotal Phase 3 trial which found that more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone. Children treated with Dupixent and topical corticosteroids (TCS) experienced approximately 80 percent average overall disease improvement.

Results at 16 weeks showed:

• 84 percent improvement in average EASI (Eczema Area and Severity Index) score from baseline in patients who received Dupixent every four weeks and 80 percent in patients who received Dupixent every two weeks, compared to 49 percent and 48 percent for TCS alone, respectively.
• 75 percent of patients who received Dupixent every four weeks and 75 percent of patients who received Dupixent every two weeks achieved EASI-75 (Eczema Area and Severity Index-75), compared to 28 percent and 26 percent for TCS alone, respectively.
• 54 percent of patients who received Dupixent every four weeks and 61 percent of patients who received Dupixent every two weeks experienced at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale), compared to 12 percent and 13 percent for TCS alone, respectively.
• 30 percent of patients who received Dupixent every four weeks and 39 percent of patients who received Dupixent every two weeks achieved clear or almost clear skin (Investigator’s Global Assessment or IGA), compared to 13 percent and 10 percent for TCS alone, respectively.

The safety profile of Dupixent with TCS was similar to what was observed in adults and adolescents with atopic dermatitis, and consistent through 52 weeks.

Revance to Acquire HintMD

Revance Therapeutics, Inc. has acquired HintMD, a financial technology platform for the aesthetics industry. Revance has agreed to pay HintMD’s shareholders a total of 8.54 million shares of Revance common stock, subject to customary adjustments provided in the acquisition agreement. The transaction is expected to close in the third quarter of 2020.

HintMD’s platform includes:

• Vertically Integrated Payments Platform – As both an authorized payment facilitator (PayFac) and payment processor, the HintMD platform can process a broad range of practice transactions. By doing so, the HintMD platform streamlines the patient checkout process and provides visibility into practice analytics and trends that are not available with traditional credit card processors or legacy systems that sit outside the normal workflow. Additionally, the HintMD platform enables secure, contactless patient checkout and seamless point-of-sale processing, particularly relevant in today’s COVID-19 environment.
• Patient Subscriptions and Loyalty Programs – The HintMD platform enables personalized subscription treatment solutions with recurring billing programs and patient wallet technology to facilitate flexible payment options. Subscription programs have demonstrated improved patient treatment compliance and practice economics. The open nature of the HintMD platform allows practices to offer their own patient loyalty programs and integrate existing brand rewards plans, while also facilitating third-party transactions, thus lowering administration time, enabling easier access of rewards, and improving payment reconciliation.

The transaction will allow Revance to provide aesthetic practices with both premium products and services, enabling them to deliver a “prestige” experience to their patients.

Galderma: Dysport Achieved High Levels of Satisfaction with Two Treatments Per Year

Topline results of DREAM (Dysport Real-world Evaluation and Measured satisfaction study), a clinical study of Dysport (abobotulinumtoxinA) for injection, showed that 95 percent of patients treated with Dysport achieved high levels of satisfaction with two treatments per year, and 97 percent of patients thought the result of the treatment looked natural, according to Galdmera. Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.

“As a physician in practice for nearly two decades, I have many long-standing patients who come in for retreatment with neuromodulators every three to four months. In the DREAM study, we were interested in evaluating patient satisfaction with a regimen in which Dysport was administered on a twice-yearly schedule,” says Joel L. Cohen, MD, a board-certified and fellowship-trained dermatologist and Director of AboutSkin Dermatology and DermSurgery in Colorado, and an investigator for the DREAM study. “We were encouraged to find in this Phase 4 study that close to 100 percent of patients were satisfied or highly satisfied with the aesthetic results of treating the lines between their eyebrows every six months for a year with Dysport. These top-line results suggest that aesthetic specialists can feel confident administering injections that match patient goals of treatment efficacy from every three to four months to a twice-yearly schedule.”

SciBase Receives FDA Approval for Nevisense 3.0

The FDA has approved SciBase AB’s Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection. Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US.

Nevisense 3.0 is a more efficient and streamlined version of the product previously approved by the FDA. The European version released at the end of 2018 has significantly improved both adoption and utilization, and has been used clinically on over 30,000 patients to date.

“The release of Nevisense 3.0 in late 2018 in Germany and the EU has been the catalyst for five consecutive quarters of growth, and we see this as step one of our strategic plan” says Simon Grant, Chief Executive Officer of SciBase. “Receiving US approval means that we can focus on step two of our strategy which is to increase our marketing and sales activities in the US based on our deep market experience with Nevisense 3.0 in Germany and the positioning we have developed for Nevisense in the US.”

CLOSE UP with Adam Friedman, MD, FAAD

Although theoretical risks exist because of spironolactone’s pro-estrogenic effects, little has been known about the safety of this commonly prescribed drug in breast cancer survivors. Given its efficacy in for the treatment of alopecia, Adam Friedman, MD, Director of the GW Supportive Oncodermatology Clinic, Interim Chair of the Department of Dermatology at the GW School of Medicine and Health Sciences in Washington, DC, and colleagues set out to determine whether or not spironolactone increases risk of breast cancer recurrence among survivors. Dr. Friedman spoke to Practical Dermatology® magazine about the study, which appears in a May 2020 issue of the Journal of the American Academy of Dermatology, and its implications for breast cancer survivors and the dermatologists who treat them.

WHY IS THIS TOPIC IMPORTANT TO STUDY?

Dr. Friedman: Spironolactone is commonly used off-label to treat androgen-dependent conditions such as acne, hidradenitis, and female-pattern hair loss. However, usage of spironolactone among patients with estrogen-dependent malignancies for alopecia is questionable due to anti-androgen and pro-estrogen effects, often resulting in discontinuation or even withholding initiation of this effective medication. Several studies have hinted at the safety of spironolactone in this population, though messaging from oncology and even dermatology has suggested otherwise. This study sought to add meaningful data to this debate in hopes of allaying concerns and enabling physician to comfortably use this medication.

DESCRIBE THE RESEARCH AND YOUR FINDINGS.

Dr. Friedman: A retrospective analysis was conducted using Humana Insurance database. Patients with a history of breast cancer were identified using ICD codes, stratified by spironolactone prescription, and matched 1:1 using propensity score analysis. Patient characteristics and cancer recurrence rates between both cohorts were compared and analyzed. Propensity-matching, adjusted cox-regression analysis showed no association between spironolactone and increased breast cancer recurrence. Interestingly though, we found the alcohol intake was positively associated with recurrence, consistent with past studies.

What is the next step?

Dr. Friedman: I think there are several next steps. First would be to prospectively study patients on spironolactone with a positive history of breast cancer as retrospective studies certainly have their limits. From the perspective of someone who runs a supportive oncodermatology program and is eager for evidenced-based approaches to treat cancer therapy-associated cutaneous adverse events, evidence further supporting the use of spironolactone for persistent chemotherapy-induced alopecia would be very meaningful. My experience with spironolactone in this area has been good, but it is certainly anecdotal.

AbbVie Completes Acquisition of Allergan

AbbVie completed its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court.

In connection with the closing of the transaction, the AbbVie Board of Directors has elected Thomas C. Freyman, retired Executive Vice President and Chief Financial Officer, Abbott, to join the AbbVie board. Mr. Freyman recently served on the Allergan Board of Directors.

“We are pleased to reach this important milestone for the Company, its employees, shareholders and the patients we serve,” says Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “Our new Allergan colleagues should be commended for all their efforts, along with those of our own employees, to achieve this turning point for our Company. The new AbbVie will be a well-diversified leader in many important therapeutic categories, with both on-market and pipeline assets, and our financial strength will allow us to continue to invest in innovative science and continue to serve unmet medical needs of patients that rely upon us. I am proud of both organizations and look forward to the opportunities ahead.”

This diversified on-market portfolio will drive the existing AbbVie growth platform (ex-Humira) to approximately $30 billion in revenues in full year 2020, with combined revenues of approximately $50 billion.

It also positions the company for enhanced long-term growth potential, a growing dividend and investment in innovation in each of its therapeutic categories. The company anticipates rapidly paying down the incremental debt with its increased operating cash flows.

Under terms of the transaction agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share, for a total consideration of $193.23 per Allergan share (based on the closing price of AbbVie’s common stock of $84.22 on May 7, 2020).

NEA Announces 2020 Eczema Research Grant Cycle Opening

The National Eczema Association (NEA) is opening its 2020 research grant cycle.

Applications must be received by Monday, Aug. 31, 2020 at 5 pm PDT, and recipients will be announced in November. Visit https://nationaleczema.org/research/research-we-fund/ for more information.

For the 2020 funding cycle, NEA has grants available in each of the following categories:

• Engagement Research Grant – up to $5,000
• Small research grants for emerging investigators intended to explore a new research concept, pilot a new experiment or undertake a novel or secondary data analysis.
• Catalyst Research Grant – up to $50,000
• Grants designed to support talented early-career scientists on the path toward becoming the next generation of eczema thought leaders by supporting hypothesis-driven research projects.
• Eczema Champion Research Grant – up to $100,000
• Grants to encourage proven researchers to continue research on emerging or ongoing challenges in eczema or bring their expertise to the field of eczema.

Applications for 2020 Research Grants are requested for the following research priorities established by NEA’s Scientific & Medical Advisory Council:

• Cutting Edge Basic & Translational Science
• Eczema Heterogeneity: Novel Insights
• Innovations in Clinical Practice & Care
• Understanding & Alleviating Disease Burden
• Eczema Prevention

How Do STATES compare in Terms of Health Infrastructure for COVID-19?

In order to determine the states that had the best health infrastructure to deal with the coronavirus pandemic, WalletHub (WalletHub.com) compared the 50 states across 14 unique metrics. “In the short term, maintaining a low infection rate (i.e., flattening the curve) will allow hospitals to manage the flow of infected patients because the virus is still making its way through communities,” notes Puneet Chehal, PhD, Assistant Professor, Rollins School of Public Health, Emory University. “Hospitals have to rely on public health officials and policymakers to provide them with adequate resources to meet patient needs as well as maintain a manageable infection rate.”