AbbVie, Evolus Agree to Settlement

AbbVie, Evolus, and Medytox have agreed to a new settlement to fully resolve all outstanding litigation, including the US International Trade Commission (ITC) case regarding the sale of Jeuveau, between the companies. A California court case filed by Medytox against Evolus will be dismissed.

Under terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau in the US and Nuceiva in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox.

This agreement follows the final determination of the ITC on December 16, 2020, which found a misappropriation of Medytox’s manufacturing trade secrets and strain of C. botulinum and concluded that a violation of Section 337 of the Tariff Act of 1930 had occurred. As Daewoong Pharmaceutical Co. Ltd. is not a party to the settlement agreements, this settlement does not affect any legal rights, positions, or proceedings between Medytox and Daewoong in Korea and other countries.

ASDSA, Northwestern Introduce CAPER System

The American Society for Dermatologic Surgery Association (ASDSA) and the Northwestern University Department of Dermatology have created the the Cutaneous Procedures Adverse Events Reporting (CAPER) system, a voluntary reporting system that gathers patients’ adverse events (AEs) encountered during dermatologic surgery procedures.

CAPER will help with safety monitoring for the specialty; identify practice and/or education gaps associated with adverse events; and identify any potential risk factors for adverse events.

CAPER will be overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes.

“I’m incredibly excited to have CAPER up and running,” says Murad Alam, MD, MBA, Vice Chair of the Northwestern University Department of Dermatology and past ASDSA President. “Having access to information to not only potentially improve patient safety, but also assess and affirm the presumed high-level of safety of dermatologic surgery, is very exciting.”

Access to de-identified data can result in the dissemination of trends related to adverse incidents and result in making patients safer.

“Establishing a data repository for dermatologic surgery, both cosmetic- and skin cancer-related, will be crucial in advancing our field and helping our patients,” adds current ASDSA President Mathew Avram, MD, JD.

Visit Caper.net for more on how to report AEs.

New ASDS Guideline Addresses Prevention and Treatment of Filler Complications

The American Society for Dermatologic Surgery (ASDS) Multispecialty Soft-tissue Fillers Guideline Task Force has released its evidence-based recommendations for physicians performing injectable filler procedures including best practices for preventing and treating vascular occlusion, nodules, and other potential complications.

The new guidelines appear in the February 2021 issue of Dermatologic Surgery.

“Evidence-based clinical guidelines provide a critical resource for physicians, and ASDS strives to be recognized as the authoritative source on the science of surgical interventional treatments of skin aging and skin disease,” says Derek Jones, MD, Chair of the ASDS Soft-tissue Fillers Guideline Task Force. “We have gathered the best available evidence within the scientific literature to form the basis for best practices in patient care for soft-tissue filler injections.”

Using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the task force identified six critical questions to focus the guidelines and inform the literature research. The questions gauged risk factors for vascular occlusion; treatments for blindness; treatment of vascular occlusion of the skin without blindness; risk factors for nodules and inflammatory events with hyaluronic acid fillers; treatments for nodules and inflammatory events; and risk factors for nodules and inflammatory events from non-hyaluronic acid fillers.

ASDS commissioned the Mayo Clinic Evidence-based Practice Center to conduct systematic reviews to extract the data and summarize the relevant evidence. The guidelines specify recommendations for the:

• Prevention of vascular occlusion, blindness, stroke.
• Treatment of filler related vascular occlusion with blindness.
• Treatment of vascular occlusion (skin) without blindness.
• Treatment of nodules and inflammatory events from hyaluronic acid fillers.
• Treatment of nodules caused from permanent and semi-permanent fillers.

Reducing risk of vascular occlusion, blindness, or stroke starts with thorough knowledge of facial anatomy including blood vessels and relevant cutaneous landmarks, the new guidelines state.

“Vascular occlusion, blindness and stroke are certainly huge fears,” says task force member Chapel Hill, NC-based dermatologist Sue Ellen Cox, MD (pictured above).

The nose, glabella, forehead, and maybe the temples, to a lesser extent, are extra high-risk areas for these complications.

“The guidelines have really outlined the facial anatomy incredibly well including where Important blood vessels are and where they connect,” she says.

Some individuals with deeply etched glabellar lines may seek filler on top of neuromodulators, but Dr. Cox is no longer planning to use filler in this area due to heightened risks. “It is such a high-risk location that we urge great caution even for the most expert physicians. I will now just do laser resurfacing, microneedling, or another technology where I can affect and improve these static lines without sticking filler in them,” she says.

To avoid nodules and inflammatory events after hyaluronic acid injection, the task force suggests using the smallest bolus possible such as 0.1 to 0.2 mL and making sure patients have not had dental procedures or invasive diagnostic and surgical procedures for more than two weeks before or after fillers.

Nodules may be related to a heigtened immune response or infection, and doctors often have to play detective to figure out the precise etiology, Dr. Cox says.

Treatment options for hypersensitivity reactions include oral steroids, hyaluronidase, intralesional triamcinolone with or without 5-fluorouracil, or a watch-and-wait approach, she says.

Feel the nodule, she suggests. “If it is tender and red that often times relates to hypersensitivity, but if it is fluctuant, soft, and warm, we put a needle in and see if there is pus and if there is, we culture it and put the patient on broad-spectrum antibiotics, she says. Biofilm infection around the filler can be more challenging to treat, she notes.

Sometimes it’s OK to hedge. “If I suspect some hypersensitivity, but am not 100 percent sure there isn’t an underlying infection, I will prescribe doxycycline with steroids to cover both things.”

The multidisciplinary task force was assembled in 2018 and consisted of ASDS member physicians, two patient representatives, and a methodologist.

Watch Now

Reactions: Does the COVID-19 Vaccine Pose Risks for Filler Patients?
In a recent episode of Coping with COVID-19, produced together with our sister publication Modern Aesthetics®, aesthetic experts weigh in on reports of reactions to the COVID-19 vaccine among patients who have received dermal fillers. The panel— Michael Gold, MD; Joel L. Cohen, MD; Joel Schlessinger, MD, FAAD; Amy Forman Taub, MD; Doris Day, MD, FAAD; Mark S. Nestor, MD, PhD; and Adam Jackson, PharmD—identify science-based strategies for treatment and patient education.
Click here to watch the full video and more in the series.