New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1

• The presentation at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting marked the first time pooled Phase 3 data from the ADORING 1 and 2 trials on Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD^®) and ≥75% improvement in Eczema Area and Severity Index (EASI75) over time has been broken out into pediatric and adult age subsets¹
• VTAMA demonstrated consistent improvements in skin clearance and disease severity, as measured by the vIGA-AD and EASI¹
• Across pediatric age groups, therapeutic responses in patients with moderate to severe atopic dermatitis emerged as early as week 2 and continued through the end of the 8-week treatment period¹

JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present results from a post hoc analysis of pooled data from the Phase 3 pivotal trials, ADORING 1 and ADORING 2, evaluating the efficacy and safety of VTAMA cream versus vehicle today at the 2026 Society for Pediatric Dermatology Annual Meeting in Minneapolis, Minnesota. VTAMA cream is the first and only aryl hydrocarbon receptor (AhR) agonist indicated for the treatment of both atopic dermatitis in adults and pediatric patients 2 years and older and plaque psoriasis in adults.

The findings show that VTAMA cream demonstrated early and consistent improvements in disease severity—as measured by vIGA-AD and EASI75—across three pediatric age groups and adults with moderate to severe atopic dermatitis.¹

“Patients can experience atopic dermatitis differently across all stages of life. In my practice I might treat a toddler differently than a teenager or adult. Having robust, age-stratified data gives us real confidence in how we counsel patients and families,” said Luz Fonacier, MD, Professor, Department of Medicine at NYC Grossman Long Island School of Medicine and Lead Author of the poster being presented at SPD. “This data is encouraging, as it shows whether patients were young children or adults, have moderate or severe atopic dermatitis, VTAMA cream demonstrated clinically meaningful early and consistent improvements in skin clearance.”

In the ADORING 1 and ADORING 2 pivotal trials, adults and children 2 years and older (N=813) with moderate to severe atopic dermatitis were randomized 2:1 to VTAMA cream or vehicle once daily for 8 weeks. The findings presented at SPD 2026 stem from a post hoc analysis of pooled data stratified by age group: 2–6 years, 7–11 years, 12–17 years, and 18 years and older.¹ Most patients (80.4%) were aged 2–17 years, reflecting the higher prevalence of atopic dermatitis in pediatric populations.^1,2

Improvements with VTAMA cream were observed as early as week 2, the first post-treatment assessment across pediatric age groups, and they continued through week 8:¹

• VTAMA cream demonstrated consistent improvements in skin clearance (vIGA-AD response) compared to vehicle at week 8 across pediatric age groups:¹
  • 2–6 years: 56.3% vs. 11.8% (P<0.0001)
  • 7–11 years: 44.9% vs. 23.8% (P=0.0172)
  • 12–17 years: 48.8% vs. 13.4% (P<0.0001)
  • ≥18 years: 38.0% vs. 18.1% (P=0.0280)
• VTAMA cream also showed consistent improvements in the proportion of patients achieving at least a 75% reduction in EASI75 at week 8:¹
  • 2–6 years: 70.2% vs. 20.5% (P<0.0001)
  • 7–11 years: 53.6% vs. 31.3% (P=0.0158)
  • 12–17 years: 62.2% vs. 18.3% (P<0.0001)
  • ≥18 years: 50.8% vs. 20.6% (P=0.0020)

The most common treatment-emergent adverse events in patients with atopic dermatitis were folliculitis, headache, and nasopharyngitis. These were generally mild or moderate in severity. Treatment discontinuations due to treatment-related adverse events occurred less frequently with VTAMA cream than with vehicle.¹

“What stands out in these data is not just the skin clearance patients achieved by week 8, but that these results were seen consistently across pediatric age groups as early as week 2,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. “Organon is committed to advancing dermatology care, and findings like these reinforce VTAMA cream as a valuable nonsteroidal option for a wide range of patients.”

First-in-class VTAMA cream is the only steroid-free, topical AhR agonist approved by the US Food and Drug Administration (FDA) for the topical treatment of atopic dermatitis in adults and pediatric patients two years of age and older and the topical treatment of plaque psoriasis in adults. ^1,3 The American Academy of Dermatology (AAD) provided strong recommendations for use of VTAMA cream for the treatment of pediatric and adult atopic dermatitis patients.³

About the Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING was the Phase 3 atopic dermatitis clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.

About VTAMA
INDICATIONS: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:

• the topical treatment of plaque psoriasis in adults
• the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older

SELECTED SAFETY INFORMATION
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

Before prescribing VTAMA cream, please read the Prescribing Information.

About Atopic Dermatitis
Atopic dermatitis, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the U.S. alone and up to 10% of adults worldwide.^4,5 Atopic dermatitis occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the U.S.^2,4 The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.⁵ Itching is an especially bothersome symptom for those with atopic dermatitis, and tends to worsen at night.⁴

About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok, and Facebook.

Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Organon's commitment to advancing dermatology care and the potential benefits, value, positioning and future role of VTAMA® (tapinarof) cream as a treatment option for patients. Forward-looking statements may be identified by words such as “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other SEC filings, available at the SEC’s Internet site (www.sec.gov).

References

1. Fonacier L, Boguniewicz M, Ohayon J, et al. Tapinarof cream 1% in atopic dermatitis: consistent efficacy across age groups from pooled ADORING trials. Poster presented at: Society for Pediatric Dermatology (SPD) Annual Meeting; July 23, 2026; Minneapolis, MN.
2. Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies; 2022. Accessed June 30, 2026. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf
3. Davis DMR, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in pediatric patients. J Am Acad Dermatol. 2026;95,121.e1-121.e26. doi:10.1016/j.jaad.2026.02.113
4. Eczema stats. National Eczema Association. Accessed June 30, 2026. https://nationaleczema.org/eczema-facts/
5. Atopic dermatitis. National Institute of Arthritis and Musculoskeletal and Skin Diseases. November 2022. Accessed June 30, 2026. https://www.niams.nih.gov/health-topics/atopic-dermatitis

vIGA-AD is a registered trademark of Eli Lilly and Co.

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