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EFFICACY

Battle-Tested Against Inflammatory Lesions Of Rosacea

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STUDY DETAILSINFLAMMATORY LESION REDUCTIONINVESTIGATOR'S GLOBAL ASSESSMENT SUCCESSIMPROVEMENT BY SEVERITYOPEN-LABEL EXTENSION STUDYVISIBLE RESULTS

STUDY DETAILS

ZILXI was evaluated in a large population in 2 identical phase 3 trials and a 40-week open-label extension study12,13

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1522 TOTAL PATIENTS*

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18+ YEARS OF AGE WITH INFLAMMATORY LESIONS OF ROSACEA

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TWO 12-WEEK TRIALS: RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED

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40-WEEK OPEN-LABEL EXTENSION, SAFETY STUDY13†

Key inclusion/exclusion criteria12

  • 15-75 facial lesions (papules and pustules) and no more than 2 facial nodules
  • IGA scale—moderate or severe score (grade 3 or 4)
  • History or presence of facial erythema and/or flushing
  • During the 12-week phase 3 trials, no other topical or systemic rosacea medication was permitted for use

Co-primary efficacy endpoints12

  • Absolute change from baseline in inflammatory lesion count at Week 12
  • IGA endpoint success at Week 12, defined as an IGA score of 0 or 1 (clear or almost clear) and at least a 2-grade improvement (decrease) from baseline

Safety evaluations12

  • Adverse events, physical examinations, vitals, dermal tolerability, laboratory testing

*Trial 1 (2:1), N=751; Trial 2 (2:1), N=771.

†Subjects were eligible to enter the open-label extension study upon successful completion of either double-blind study (Trial 1 or Trial 2).

IGA = Investigator’s Global Assessment.

ZILXI packs a punch against inflammatory lesions of rosacea in adults with rapid results

Reduction of inflammatory lesions occurred as early as week 4

CHANGE FROM BASELINE IN INFLAMMATORY LESION COUNT THROUGH WEEK 12‡

TRIAL 1
TRIAL 2
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‡ANCOVA, intent-to-treat.

ABSOLUTE REDUCTION OF INFLAMMATORY LESION COUNT

Light blue box with dark blue and orange numbers showing mean reductions from Trials 1 and 2Light blue box with dark blue and orange numbers showing mean reductions from Trials 1 and 2
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Investigator’s Global assessment TREATMENT SUCCESS IN PHASE 3 CLINICAL TRIALS

Patients receiving ZILXI demonstrated improvement in IGA success at week 12

IGA Treatment Success at Week 12

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§IGA treatment success was defined as dichotomized (yes/no) IGA score of 0 or 1 and at least a 2-grade improvement from baseline at Week 12.

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AT WEEK 12, THE PROPORTION OF SUBJECTS ACHIEVING IGA TREATMENT SUCCESS WITH ZILXI WAS SIGNIFICANTLY HIGHER VS VEHICLE

IMPROVEMENT BY SEVERITY

Post-hoc assessment of ZILXI across IGA disease severities

A post-hoc assessment pooled the co-primary efficacy endpoint data from Trial 1 and Trial 2 for analysis both in totality and for the predefined subgroup of baseline disease severity (moderate, IGA=3; or severe, IGA=4)14

POST-HOC ANALYSIS of Zilxi Across IGA Disease Severities14

ABSOLUTE REDUCTION IN INFLAMMATORY LESION COUNT
IGA TREATMENT SUCCESS
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IGA = Investigator's Global Assessment.

Integrated efficacy population (multiple imputation).

#Observed cases.

  • Limitation: This is a post-hoc analysis, which is considered exploratory; therefore, the results require cautious interpretation and could represent chance findings
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Effective Across Moderate to Severe IGA Disease Severities

OPEN-LABEL EXTENSION STUDY

40-week extension safety study

The multicenter, open-label extension study, which included 504 patients, evaluated the long-term safety, tolerability, and efficacy of ZILXI. Patients were eligible to enter the open-label extension study upon successful completion of either double-blind study (Trial 1 or Trial 2)13

Change in Inflammatory LESION COUNT Through Week 52

PERCENTAGE REDUCTION
ABSOLUTE REDUCTION
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Number of subjects remaining in the study
WeekZILXI 1.5%  MST-enabled vehicle ->ZILXI 1.5%
0332172
4332172
8331172
12332172
16326168
22321156
28310150
34298146
40286138
46279136
52272129

Change from baseline is calculated as the value at baseline minus the post-baseline value.

  • Limitations: These results must be interpreted with caution. The open-label study was not designed for efficacy and may be confounded by evaluator bias, and results could represent chance findings. In total, 4.6% of participants reported using a concomitant dermatological medication13

IGA TREATMENT SUCCESS AT WEEK 12 AND THROUGH OPEN-LABEL EXTENSION STUDY

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IGA = Investigator’s Global Assessment.

Week 12 of the double-blind study serves as the baseline for the open-label extension study.

  • Limitations: These results must be interpreted with caution. The open-label study was not designed for efficacy and may be confounded by evaluator bias, and results could represent chance findings. In total, 4.6% of participants reported using a concomitant dermatological medication13
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PATIENTS SAW CONTINUED REDUCTION OF INFLAMMATORY LESION COUNT AND IMPROVEMENT IN IGA SCORES THROUGH WEEK 5213

REAL PATIENTS, VISIBLE RESULTS

ZILXI—see the difference of first-line power

IGA SCORE=4

IGA SCORE=1

BASELINE

WEEK 12

Picture of a female patient with rosacea post-treatment with Zilxi
Picture of a female patient with rosacea pre-treatment with Zilxi

SLIDE TO SEE BEFORE AND AFTER

IGA SCORE=3

IGA SCORE=2

BASELINE

WEEK 12

Picture of a male patient with rosacea post-treatment with Zilxi
Picture of a male patient with rosacea pre-treatment with Zilxi

SLIDE TO SEE BEFORE AND AFTER

  • Images from clinical studies.15 Clinical pictures used with permission. Photos from individual patients may not be typical, as individual results vary
  • IGA treatment success at Week 12 was defined as an IGA score of 0 or 1 (clear or almost clear) and at least a 2-grade improvement (decrease from baseline)
  • The average absolute reduction in inflammatory lesions and percentage of patients achieving IGA endpoint success at Week 12 was -18.0 vs -14.9 and 50.6% vs 41.0%, respectively14||

||Please see full clinical efficacy data above.

CONTINUE TO
SAFETY
IMPORTANT SAFETY INFORMATION

Contraindications

Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.

Warnings and Precautions

Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue ZILXI.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue ZILXI.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue ZILXI immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue ZILXI immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using ZILXI. Advise patients to discontinue treatment with ZILXI at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue ZILXI immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue ZILXI and institute appropriate therapy.

Adverse Reactions

The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.

Indications and Usage

ZILXI (minocycline) topical foam, 1.5% is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.

Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.

Please click to access full Prescribing Information.

IMPORTANT SAFETY INFORMATIONOrange arrow

Contraindications

Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.

Warnings and Precautions

Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue ZILXI.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue ZILXI.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue ZILXI immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue ZILXI immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using ZILXI. Advise patients to discontinue treatment with ZILXI at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue ZILXI immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue ZILXI and institute appropriate therapy.

Adverse Reactions

The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.

Indications and Usage

ZILXI (minocycline) topical foam, 1.5% is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.

Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.

Please click to access full Prescribing Information.

REFERENCES

  1. Sapadin AN, et al. J Am Acad Dermatol. 2006;54(2):258-265.
  2. Mrowietz U, et al. Am J Clin Dermatol. 2018;19(3):427-436. doi: 10.1007/s40257-017-0339-0.
  3. Rivero AL, Whitfeld M. Aust Prescr. 2018;41(1):20‐24. doi: 10.18773/austprescr.2018.004.
  4. Jones TM, et al. J Drugs Dermatol. 2017;16(10):1022-1028.
  5. Hazot Y, et al. J Anal Pharm Res. 2017;4(5):00117.
  6. Tamarkin D. Foam: a unique delivery vehicle for topically applied formulations. In: Dayan N, ed. Handbook of Formulating Dermal Applications: A Definitive Practical Guide. Beverly, MA: Scrivener Publishing LLC; 2017:233-260.
  7. Moribe K, et al. Chem Pharm Bull. 2010;58(8):1096-1099.
  8. Yokota J, et al. J Chin Med Assoc. 2018;81(6):511-519.
  9. Tamarkin D, et al. Expert Opin Drug Deliv. 2006;3(6):799-807.
  10. ZILXI™ (minocycline) topical foam, 1.5% Prescribing Information. Scottsdale, AZ: Journey Medical Corporation; 2022.
  11. Lin TK, et al. J Mol Sci. 2017;19(1):70. doi: 10.3390/ijms19010070.
  12. Stein Gold L, et al. J Am Acad Dermatol. 2020;82(5):1166-1173. doi: 10.1016/j.jaad.2020.01.043.
  13. Stein Gold L, et al. Open-label extension study evaluating the long-term safety, efficacy, and tolerability of FMX103 1.5% topical minocycline foam in the treatment of moderate-to-severe facial papulopustular rosacea. Poster presented at: 39th Annual Fall Clinical Dermatology Conference®; October 17-20, 2019; Las Vegas, Nevada.
  14. Del Rosso JQ, et al. Integrated summary of efficacy of FMX103 1.5% topical minocycline foam for the treatment of moderate-to-severe papulopustular rosacea: results from two Phase 3 studies. Poster presented at: 17th Annual South Beach Symposium in Dermatology; February 6-9, 2020; Miami, Florida.
  15. Data on file. Journey Medical Corporation.
  16. Jones TM, et al. SKIN J Cutan Med. 2019;3(2). doi: 10.25251/skin.3.2.2.
  17. Stein Gold L, et al. Integrated safety analysis of FMX103 1.5% topical minocycline foam for the treatment of moderate-to-severe papulopustular rosacea (PPR): results from two Phase 3 studies. Poster presented at: American Academy of Dermatology Annual Meeting; March 20-24, 2020; Denver, CO. Poster No. 13509.

Foamix Pharmaceuticals is a wholly owned subsidiary of VYNE Therapeutics Inc.

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