Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for “Extra-Strength” 40U Formulation of Jeuveau®

Rhea-AI Summary

Evolus, Inc. (NASDAQ: EOLS) announces the publication of safety and duration data from a Phase 2 study for the 'extra-strength' 40U formulation of Jeuveau® in treating moderate to severe glabellar lines. The study showed a duration effect of 26 weeks based on improvement in Glabellar Line Scale (GLS) and Global Aesthetic Improvement Scale, with a focus on safety and efficacy.

Positive

• Publication of safety and duration data from Phase 2 study for 'extra-strength' 40U Jeuveau® formulation
• Study demonstrated 26-week duration effect for improvement in glabellar lines
• Safety profile showed 88.9% of adverse events rated as mild with no serious adverse events identified
• Correlation between increasing dose and duration of effect confirmed with similar safety profile
• Jeuveau® approved for temporary improvement in appearance of moderate to severe glabellar lines in adults below 65 years of age
• Product clinically proven to improve glabellar lines and received regulatory approval in multiple countries

Negative

• None.

• The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting
• Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau^® (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients.

The “extra-strength” glabellar line study is a multicenter, double-blind, randomized, Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau^® Extra-Strength 40U and two active controls, BOTOX^® 20U and Jeuveau^® 20U.

Efficacy results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale. The safety profile was similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified.

“This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. “The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild.”

Jeuveau^® is approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. Through the company’s TRANSPARENCY Clinical Program, Jeuveau^® was clinically proven to temporarily improve moderate to severe glabellar lines or “11’s” in adults and included the largest head-to-head pivotal study versus BOTOX^®. The product is approved for sale in the U.S. under the brand name Jeuveau^® and in Europe and Canada under the brand name Nuceiva^® and received regulatory approval in Australia in January 2023.

About “Extra-Strength” Glabellar Line Study

The “Extra-Strength” Glabellar Line Study is a multicenter, double-blind, randomized trial that followed 150 patients until they lost their correction or up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau^® and 20 units of BOTOX^® – which were compared to 40 units of Jeuveau^® in addition to evaluating the safety, efficacy, and duration of effect.

About Evolus, Inc.

Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau^® (prabotulinumtoxinA-xvfs), globally licensed under the brand name Nuceiva^®. The product is manufactured in a state-of-the-art facility using Hi-Pure™ technology. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse™, a line of five unique dermal fillers currently in late-stage development. Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram or Facebook.

IMPORTANT SAFETY INFORMATION FOR JEUVEAU^® (prabotulinumtoxinA-xvfs)

JEUVEAU may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC^®), onabotulinumtoxinA (BOTOX^®/BOTOX^® Cosmetic), abobotulinumtoxinA (DYSPORT^®), or incobotulinumtoxinA (XEOMIN^®); have a skin infection at the planned injection site; or are a child.

JEUVEAU dosing units are not the same as, or comparable to, any other botulinum.

Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, Myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of JEUVEAU.

Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.

Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).

JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

JEUVEAU can cause other serious side effects including: allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

APPROVED USE

JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com or talk to your healthcare provider.

To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660

Forward-Looking Statements

This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical or current facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The company’s forward-looking statements include, but are not limited to, statements related to market conditions and consumer demand; expectations regarding regulatory approvals, product launches, and market adoption for extra-strength formulation of Jeuveau^®.

The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau^® and Evolysse™, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse™ dermal filler product line in the U.S., our ability to maintain regulatory approvals of Jeuveau^® or obtain regulatory approvals for new product candidates or indications, our reliance on Symatese to achieve regulatory approval for the Evolysse™ dermal filler product line in the U.S., and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 7, 2024. These filings can be accessed online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.

Jeuveau^®, Nuceiva^®, and Evolysse™ are trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Estyme^® is a trademark of Symatese Aesthetics S.A.S.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240417717464/en/

Investors:

Nareg Sagherian

Vice President, Head of Global Investor Relations and Corporate Communications

Tel: 248-202-9267

Email: ir@evolus.com

Media:

Email: media@evolus.com

Source: Evolus

FAQ

What is the focus of the Phase 2 study announced by Evolus, Inc. (NASDAQ: EOLS)?

The Phase 2 study focuses on the safety and duration of effect of the 'extra-strength' 40U formulation of Jeuveau® for treating moderate to severe glabellar lines.

What was the duration effect observed in the study?

The study demonstrated a duration effect of 26 weeks, or 6 months, based on improvement in Glabellar Line Scale (GLS) and return to baseline using the Global Aesthetic Improvement Scale.

What percentage of adverse events were rated as mild in the study?

Overall, 88.9% of adverse events were rated as mild in the Phase 2 study.

What is Jeuveau® approved for?

Jeuveau® is approved for the temporary improvement in the appearance of moderate to severe glabellar lines in adults below 65 years of age.

Where has Jeuveau® received regulatory approval?

Jeuveau® has received regulatory approval in the U.S. under the brand name Jeuveau®, in Europe and Canada as Nuceiva®, and in Australia.

Who commented on the study results?

Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus, commented on the study results confirming the correlation between dose and duration of effect.

What was the key finding regarding the safety profile in the study?

The safety profile was similar across all arms, with no serious adverse events identified.

What is the main focus of the TRANSPARENCY Clinical Program for Jeuveau®?

The TRANSPARENCY Clinical Program focuses on proving the temporary improvement in moderate to severe glabellar lines in adults.

How does Jeuveau® compare to BOTOX®?

Jeuveau® included the largest head-to-head pivotal study versus BOTOX® in treating glabellar lines.

What was the outcome of the Phase 2 study in terms of efficacy?

The study demonstrated a 26-week duration effect across multiple metrics, including improvement in GLS and return to baseline GLS score after treatment.