Ortho Dermatologics Will Present New Data at the 2022 American Academy of Dermatology Annual Meeting

“At this year’s AAD meeting, we look forward to sharing new data on our investigational acne medicine, IDP-126 Gel, as well as new analyses on two of our psoriasis medicines, DUOBRII and SILIQ,” said Joseph C. Papa, chairman and CEO, Bausch Health. “We will also introduce the JUBLIA® virtual reality experience, which was designed to provide insight into onychomycosis, a condition that affects as many as 35 million people in the United States each year and highlights the benefits of using JUBLIA® as a treatment option.”

One poster presentation will feature new analyses of the investigational medicine IDP-126 Gel, a combination retinoid, anti-bacterial and antibiotic topical, including new safety and efficacy results from a Phase 2 and two Phase 3 studies on participants with moderate-to-severe acne. If approved, IDP-126 would be the first-in-class treatment with this triple combination.

The second presentation will highlight the efficacy results of DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% in maintaining skin clearance in a long-term open-label study evaluating participants with prior use of topical treatments.

The last presentation will provide the results from multiple studies assessing the efficacy of SILIQ® (brodalumab) Injection for the treatment of nail and scalp psoriasis and how these results may differ by gender. Please see below for Boxed Warning about suicidal ideation and behavior with SILIQ.

For the first time at the AAD annual meeting, attendees will have the opportunity to explore onychomycosis from beneath the toenail through the JUBLIA® Virtual Reality Experience. This immersive experience will be offered through virtual reality goggles to detail the condition and demonstrate how JUBLIA® (efinaconazole) Topical Solution, 10%, which received the American Podiatric Medical Association (APMA) Seal of Approval in December 2021, can be used as an effective treatment option.

The complete list of poster presentations that will be presented is as follows:

 IDP-126 Gel (Investigational Drug)

  • “Efficacy and Safety of a Fixed-Dose Clindamycin 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: Randomized Phase 2 and Phase 3 Studies of the First Triple-Combination Drug.” Stein Gold et al.

DUOBRII® (halobetasol propionate and tazarotene) Lotion

  • “Maintenance of Skin Clearance in a Long-term Open-label Study of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for Psoriasis in Participants With Prior Use of Topical Treatments.” Stein Gold et al.

SILIQ® (brodalumab) Injection

  • “Analysis of Nail or Scalp Psoriasis by Gender in Clinical Studies of Brodalumab.” Elewski et al.  

Important Safety Information for SILIQ (brodalumab) Injection

What is SILIQ?
SILIQ® injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:

  • who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and
  • who have tried another systemic therapy that didn’t work or stopped working

It is not known if SILIQ is safe and effective in children. 

What is the most important information I should know about SILIQ?

Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives.  This risk is higher if you have a history of suicidal thoughts or depression.  It is not known if SILIQ causes these thoughts or actions.  Get medical help right away if you or a family member notices that you have any of the following symptoms:

  • new or worsening depression, anxiety, or mood problems
  • thoughts of suicide, dying, or hurting yourself
  • attempt to commit suicide, or acting on dangerous impulses
  • other unusual changes in your behavior or mood

Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away.  Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.

Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections:

  • Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it
  • You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination

Who should not use SILIQ?
Do not use SILIQ if you have Crohn’s disease.  Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness as these may be symptoms of Crohn’s disease.  

Before starting SILIQ, tell your healthcare provider if you:

  • have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems
  • have an infection that does not go away or keeps coming back
  • have TB or have been in close contact with someone with TB
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ
  • are or plan to become pregnant or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use SILIQ?
See the detailed “Instructions for Use” that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes.  Use SILIQ exactly as your healthcare provider tells you to use it.

What are possible side effects of SILIQ?
SILIQ may cause serious side effects.  See “What is the most important information I should know about SILIQ?” and “Who should not take SILIQ?”

The most common side effects of SILIQ include:

Joint pain

Muscle pain

Headache

Injection site reactions

Tiredness

Flu

Diarrhea

Low white blood cell count (neutropenia)

Mouth or throat pain

Fungal infections of the skin

Nausea


Call your doctor for medical advice on side effects.  You are encouraged to report negative side effects of prescription drugs to Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Click here for accompanying full Prescribing Information, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

Important Safety Information for DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%

What is DUOBRII® Lotion?
DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.

Important Safety Information

  • DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.

What is the most important information I should know about DUOBRII Lotion?
DUOBRII Lotion may cause birth defects if used during pregnancy.
A negative pregnancy test must be obtained before females of child-bearing age start using DUOBRII Lotion and they must use effective birth control during treatment. Begin treatment during a normal menstrual period.

Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.
Before you use DUOBRII Lotion, tell your healthcare provider if you:

  • have eczema or any other skin problems, including skin infections, which may need to be treated before using DUOBRII.
  • have diabetes, adrenal gland problems or liver problems.
  • are breastfeeding or plan to breastfeed. If you use DUOBRII and breastfeed, do not apply DUOBRII to your nipple area.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Especially tell your healthcare provider if you take corticosteroids by mouth or injection or use other skin products that contain corticosteroids.
  • Ask your healthcare provider for a list of medicines that may make your skin more sensitive to sunlight.

What should I avoid during treatment with DUOBRII?

  • To avoid a severe sunburn, avoid sunlight, including sunlamps and tanning beds, as much as possible, and use sunscreen, protective clothing and a hat while in sunlight. Talk to your healthcare provider if you get sunburn, and do not use DUOBRII Lotion until your sunburn is healed.
  • Avoid using DUOBRII on skin with eczema because it may cause severe irritation.

DUOBRII may cause side effects, including:

  • If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
  • Cushing’s syndrome, a condition from too much exposure to the hormone cortisol
  • High blood sugar (hyperglycemia)
  • Effects of growth and weight in children
  • Skin irritation. If you get too much skin irritation at the site of application, your healthcare provider may tell you to interrupt or stop using DUOBRII or to use it less often.
  • Vision problems, including an increased chance of developing cataracts and glaucoma. Tell your healthcare provider about any vision problems during treatment.

The most common side effects of DUOBRII Lotion include: redness, itching, swelling, burning, stinging,  application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash. To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information, including Patient Information.

Important Safety Information for JUBLIA® (efinaconazole) Topical Solution, 10%

INDICATION
JUBLIA® (efinaconazole) Topical Solution, 10% is a prescription medicine used to treat fungal infections of the toenails.

IMPORTANT SAFETY INFORMATION

  • JUBLIA® is for use on nails and surrounding skin only. Do not use JUBLIA® in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor.
  • The safety and efficacy of JUBLIA® have not been established in children under six years old.
  • Before you use JUBLIA®, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether JUBLIA® can harm an unborn fetus or nursing infant.
  • Tell your doctor about all medications you are taking, and whether you have any other nail infections.
  • JUBLIA® is flammable. Avoid heat and flame while applying JUBLIA® to your toenail.
  • JUBLIA® may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your doctor about any side effects that bother you or do not go away.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information, including Patient Information.

Visit www.jubliarx.com to learn more.

About Acne Vulgaris
Acne is the most common skin problem in the United States, which occurs when hair follicles become plugged with oil and skin cells, often causing whiteheads, blackheads or pimples to appear on the face, forehead, chest, upper back and shoulders.1,2 Up to 50 million Americans have acne.2 Depending on its severity, acne can cause emotional distress and scar the skin.2 

About Psoriasis
Psoriasis is an immune-mediated disease that speeds up the life cycle of skin cells, causing them to build up rapidly on the surface of the skin. The extra skin cells form raised, red, scaly patches that are itchy and sometimes painful.3 People with psoriasis are also reported to be at increased risk of developing other serious clinical conditions such as cardiovascular and other noncommunicable diseases and to suffer substantial impairment of physical and psychological quality of life.4 Plaque psoriasis is the most common type of psoriasis.5

About Onychomycosis
Onychomycosis is a common condition, caused predominantly by various fungal organisms (fungi), and typically occurs under the toenail, though fingernails may also be affected. The condition typically begins as a small white or yellow spot beneath the nail, and causes nail discoloration, thickening and/or distortion and irregular surface changes. A severe case of nail fungus can be painful and may cause permanent nail damage.6

About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.

 About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

  1. American Academy of Dermatology. (2020). Skin conditions by the numbers. Retrieved from https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed December 21, 2021.
  2. Mayo Clinic. (2020). Acne. Retrieved from https://www.mayoclinic.org/diseases-conditions/acne/symptoms-causes/syc-20368047. Accessed December 21, 2021.
  3. Mayo Clinic. (2019). Psoriasis. Retrieved from https://www.mayoclinic.org/diseases- conditions/psoriasis/symptoms-causes/syc-20355840. Accessed December 21, 2021.
  4. World Health Organization. (2016). Global Report on Psoriasis. Retrieved from http://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf;jsessionid=81463A56 C4318AF777E56018DB67B563?sequence=1. Accessed December 21, 2021.
  5. National Psoriasis Foundation. About Psoriasis. Retrieved from https://www.psoriasis.org/about-psoriasis. Accessed December 21, 2021.
  6. Mayo Clinic. “Nail Fungus.” Retrieved from: https://www.mayoclinic.org/diseases-conditions/nail-fungus/symptoms-causes/syc-20353294. Accessed Dec. 2, 2021.

®/TM are trademarks of Ortho Dermatologics’ affiliated entities.
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SOURCE Bausch Health Companies Inc.

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