ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC • Presented at Winter Clinical 2021 • January 16-24, 2021 • Virtual SYNOPSIS � Acne is common among adolescents, occurring in 85% of this population1 � The overall prevalence of acne tends to decrease with age; however, acne can persist throughout adulthood, more often in females than males2,3 � In addition, older age and female sex are associated with greater negative impacts on quality of life4 � The first lotion formulation of tazarotene 0.045%, developed using a novel polymeric emulsion technology, was efficacious and well tolerated in two phase 3 studies of patients ≥9 years of age with moderate-to-severe acne (NCT03168334 and NCT03168321)5 OBJECTIVE � To assess the effects of age on efficacy and safety of tazarotene 0.045% lotion in females with moderate- to-severe acne METHODS � In two phase 3 randomized, double-blind, vehicle- controlled studies, eligible participants aged ≥9 years with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle once daily for 12 weeks • CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) were provided as needed for optimal moisturization/cleaning of the skin � Data from these studies were pooled and analyzed post hoc from female participants who were categorized by age: 13–19 years, 20–29 years, and 30+ years � Efficacy assessments included mean reductions in inflammatory/noninflammatory lesion counts and percentage of participants achieving treatment success (≥2-grade reduction in Evaluator’s Global Severity Score [EGSS] and rating of ‘clear’ or ‘almost clear’) � Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed FIGURE 1. Lesion Reductions by Age Group and Visit (ITT Population, Pooled) -36.3% -45.1% -53.2% -36.1% -52.1% -61.0% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=241) Tazarotene 0.045% Lotion (n=238) 20–29 Years13–19 Years ** -41.4% -51.0% -58.8% -35.5% -50.8% -60.2% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=71) Tazarotene 0.045% Lotion (n=72) 30+ Years -30.5% -40.8% -49.7% -29.7% -47.2% -59.3% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=199) Tazarotene 0.045% Lotion (n=192) * ** -29.4% -37.5% -48.3%-37.7% -50.3% -60.0% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=241) Tazarotene 0.045% Lotion (n=238) ** *** -31.0% -40.8% -48.5%-35.3% -50.4% -59.4% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=71) Tazarotene 0.045% Lotion (n=72) -21.5% -29.8% -39.9%-32.5% -46.6% -55.4% -70% -60% -50% -40% -30% -20% -10% 0% Baseline Week 4 Week 8 Week 12 Vehicle Lotion (n=199) Tazarotene 0.045% Lotion (n=192) *** *** *** *** 20–29 Years13–19 Years 30+ Years LS M e an C h an g e F ro m B as e lin e LS M e an C h an g e F ro m B as e lin e A. In�ammatory Lesions B. Nonin�ammatory Lesions *P<0.05; **P<0.01; ***P≤0.001 vs vehicle. No significant differences between age groups at weeks 4, 8, or 12. ITT, intent to treat; LS, least-squares. Efficacy and Safety of Tazarotene 0.045% Lotion in Female Patients with Moderate-to-Severe Acne: Post Hoc Analysis by Age FIGURE 3. Cutaneous Safety and Tolerability by Age Group (Pooled Safety Population) P e rc e n ta g e o f P ar ti ci p an ts 0% 20% 40% 60% 80% 100% 13–19 Years 30+ Years TAZ VEH TAZ VEH TAZ VEH 0% 20% 40% 60% 80% 100% 13–19 Years 30+ Years TAZ VEH TAZ VEH TAZ VEH P e rc e n ta g e o f P ar ti ci p an ts 0% 20% 40% 60% 80% 100% 13–19 Years 30+ Years TAZ VEH TAZ VEH TAZ VEH 0% 20% 40% 60% 80% 100% 13–19 Years 30+ Years TAZ VEH TAZ VEH TAZ VEH Scaling 20–29 Years Erythema 20–29 Years Hyperpigmentation 20–29 Years Itching 20–29 Years Baseline Week 12 Moderate Severe Mild Moderate Severe Mild Data for ‘none’ are not shown. N values were as follows: 13–19 years: TAZ baseline n=190, TAZ week 12 n=166, VEH baseline n=197, VEH week 12 n=184; 20–29 years: TAZ baseline n=228, TAZ week 12 n=198, VEH baseline n=231, VEH week 12 n=198; 30+ years: TAZ baseline n=70, TAZ week 12 n=59, VEH baseline n=67, VEH week 12 n=62. TAZ, tazarotene 0.045% lotion; VEH, vehicle lotion. RESULTS Participants � The pooled population included 1,013 adolescent and adult female participants: 13–19 years (tazarotene n=192, vehicle n=199); 20–29 years (n=238, n=241); 30+ years (n=72, n=71) � >90% of female participants in each age group had an EGSS score of 3 (‘moderate’) at baseline: 13–19 years (91.6%), 20–29 years (93.1%), 30+ years (93.0%) Efficacy � Female participants in all 3 age groups had approximately 55–60% mean reductions from baseline in inflammatory and noninflammatory lesion counts with tazarotene 0.045% lotion (Figure 1) • In the younger groups (13–19 and 20–29 years), least-squares mean percent reductions in lesion counts were significantly greater with tazarotene versus vehicle at week 12 • Similar reductions with tazarotene were observed in older participants (30+ years); however, the results were not statistically significant versus vehicle, possibly due to the smaller sample size and/or relatively larger vehicle response • In tazarotene-treated females, no significant differences were observed across age groups at any week � At week 12, more females achieved treatment success with tazarotene versus vehicle: 13–19 years (26.4% vs 14.8%, P<0.01); 20–29 years (38.4% vs 25.5%, P<0.01); 30+ years (36.4% vs 25.7%, P>0.05); there was a significant difference across the 3 age groups (P<0.05) � Images depicting acne improvement are shown in Figure 2 Safety � No notable age-related patterns were found for safety outcomes � Most treatment-related TEAEs with tazarotene were mild or moderate; application site pain and dryness were the most common treatment-related TEAEs (Table 1) � Less than 10% of tazarotene-treated participants in any age group had hypopigmentation, burning, or stinging at baseline or week 12 (data not shown) � Across all age groups, rates of erythema and hyperpigmentation—more common at baseline than scaling or itching—remained relatively unchanged or reduced from baseline to week 12 (Figure 3) FIGURE 2. Acne Improvements in Females Treated with Tazarotene 0.045% Lotion Protocol: V01-123A-302 | Site: 229 | Subject: 229006 | Initials: OTD Visit: Baseline Day 0 | Visit Date: 21Sep2017 | View: Right | Treatment: IDP-123 Lotion Protocol: V01-123A-302 | Site: 210 | Subject: 210004 | Initials: KPS Visit: Baseline Day 0 | Visit Date: 04Dec2017 | View: Right | Treatment: IDP-123 Lotion Protocol: V01-123A-302 | Site: 234 | Subject: 234029 | Initials: SEC Visit: Baseline Day 0 | Visit Date: 05Feb2018 | View: Right | Treatment: IDP-123 Lotion Protocol: V01-123A-302 | Site: 229 | Subject: 229006 | Initials: OTD Visit: Week 12 | Visit Date: 13Dec2017 | View: Right | Treatment: IDP-123 Lotion Protocol: V01-123A-302 | Site: 210 | Subject: 210004 | Initials: KPS Visit: Week 12 | Visit Date: 27Feb2018 | View: Right | Treatment: IDP-123 Lotion Protocol: V01-123A-302 | Site: 234 | Subject: 234029 | Initials: SEC Visit: Week 12 | Visit Date: 01May2018 | View: Right | Treatment: IDP-123 Lotion 18-Year-Old Female 24-Year-Old Female 32-Year-Old Female Baseline EGSS=3 Baseline EGSS=3 Baseline EGSS=3 Week 12 EGSS=1 Week 12 EGSS=0 Week 12 EGSS=1 Individual results may vary. EGSS, Evaluator’s Global Severity Score (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). Linda Stein Gold, MD1; Hilary Baldwin, MD2; Fran E Cook-Bolden, MD3; Lawrence Green, MD4; Glynis Ablon, MD5; Neil Sadick, MD6; Jonathan Weiss, MD7; Eric Guenin, PharmD, PhD, MPH8 1Henry Ford Hospital, Detroit, MI; 2The Acne Treatment and Research Center, Brooklyn, NY and The Robert Wood Johnson University Hospital, New Brunswick, NJ; 3Fran E. Cook-Bolden, MD, PLLC and Department of Dermatology, Mount Sinai Hospital Center, New York, NY; 4Department of Dermatology, George Washington University School of Medicine, Washington, DC; 5Ablon Skin Institute & Research Center, Manhattan Beach, CA; 6Department of Dermatology, Weill Cornell Medical College, New York, NY and Sadick Dermatology, New York, NY; 7Georgia Dermatology Partners and Gwinnett Clinical Research Center, Inc., Snellville, GA; 8Ortho Dermatologics*, Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC. TABLE 1. Treatment-Emergent Adverse Events by Age Group (Pooled Safety Population) Percentage of participants 13–19 Years 20–29 Years 30+ Years TAZ (n=190) VEH (n=197) TAZ (n=228) VEH (n=231) TAZ (n=70) VEH (n=67) Any TEAE 28.4 19.8 35.5 18.2 25.7 16.4 Treatment-related TEAEs 14.7 1.0 16.2 2.2 12.9 1.5 Intensity of treatment-related TEAEs Mild 8.4 0.5 10.5 0.9 10.0 0 Moderate 5.3 0.5 4.4 0.9 2.9 1.5 Severe 1.1 0 1.3 0.4 0 0 Common treatment-related TEAEsa Application site pain 6.8 0.5 6.6 0.4 7.1 0 Application site dryness 4.2 0 6.6 0.4 2.9 0 Application site erythema 4.2 0 1.8 0 0 0 Application site exfoliation 2.6 0 3.9 0 1.4 0 Application site pruritus 2.6 0 0.4 0 1.4 0 aReported in ≥2% of tazarotene-treated participants in any age group. TAZ, tazarotene 0.045% lotion; TEAE, treatment-emergent adverse event; VEH, vehicle lotion. CONCLUSIONS � Treatment with tazarotene 0.045% lotion reduced inflammatory and noninflammatory lesions by approximately 55–60% in adolescent and adult females with moderate-to- severe acne � No age-related trends for safety/tolerability were observed; erythema and hyperpigmentation remained relatively unchanged or improved with tazarotene 0.045% lotion REFERENCES 1. Zaenglein AL, et al. J Am Acad Dermatol. 2016;74(5):945-973.e933. 2. Skroza N, et al. J Clin Aesthet Dermatol. 2018;11(1):21-25. 3. Collier CN, et al. J Am Acad Dermatol. 2008;58(1):56-59. 4. Tan JK, et al. J Cutan Med Surg. 2008;12(5):235-242. 5. Tanghetti EA et al. J Drugs Dermatol. 2020;19(3):272-279. AUTHOR DISCLOSURES Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis and Lilly. Hilary Baldwin has served as advisor, investigator, and on speakers’ bureaus for Almiral, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. Fran Cook-Bolden has served as consultant, speaker, investigator for Galderma, LEO Pharma, Almirall, Cassiopea, Ortho Dermatologics, Investigators Encore, Foamix, Hovione, Aclaris, Cutanea. Lawrence Green as served as investigator, consultant, or speaker for: Almirall, Cassiopea, Galderma, Ortho Dermatologics, Sol Gel, Sun Pharma, and Vyne. Glynis Ablon has served as a consultant and advisory board member for Galderma, Sinclair, Thermi-Almirall, Erchonia, Sunetics, Nutrafol, and Lifes2Good. Neil Sadick has served on advisory boards, as a consultant, investigator, speaker, and/or other and has received honoraria and/or grants/research funding from Almirall, Actavis, Allergan, Anacor Pharmaceuticals, Auxilium Pharmaceuticals, Bausch Health, Bayer, Biorasi, BTG, Carma Laboratories, Cassiopea, Celgene, Cutera, Cynosure, DUSA Pharmaceuticals, Eclipse Medical, Eli Lilly and Company, Endo International, EndyMed Medical, Ferndale Laboratories, Galderma, Gerson Lehrman Group, Hydropeptide, Merz Aesthetics, Neostrata, Novartis, Nutraceutical Wellness, Palomar Medical Technologies, Prescriber’s Choice, Regeneron, Roche Laboratories, Samumed, Solta Medical, Storz Medical AG, Suneva Medical, Vanda Pharmaceuticals, and Venus Concept. Jonathan Weiss is a consultant, speaker, advisor, and/or researcher for AbbVie, Ortho Dermatologics, Jansen Biotech, Dermira, Almirall, Brickell Biotech, DermTech, Scynexis. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.