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Updated Guidance: VYJUVEK is now approved for use from birth, can be applied by a caregiver or patient at-home, has an increased weekly volume, & has the flexibility of being removed at your next dressing change.

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Updated Guidance
VYJUVEK is now approved for use from birth, can be applied by a caregiver or patient at-home, has an increased weekly volume, & has the flexibility of being removed at your next dressing change.

Study Design

Study designs: GEM-3 & Open Label Extension (OLE)1,2

GEM-3 Study (Phase 3 intra-patient, randomized, double-blind, multicenter study)1,2

Chart of VYJUVEK™ GEM-3 study design
Chart of VYJUVEK™ GEM-3 study design

OLE Study (Multicenter study to provide extended access to patients enrolled in the GEM-3 study)3

Chart of VYJUVEK™ GEM-3 study design
OLE Study
OLE study
Patient characteristics and eligibility criteria were similar between the GEM-3 and OLE studies.3

Patient eligibility criteria1,3

Key inclusion criteria

  • Age ≥6 months with a genetically confirmed DEB diagnosis
  • Two cutaneous wounds meeting selection criteria:
    • Similar size, anatomical region, and appearance
    • Clean, adequate granulation tissue, excellent vascularization, not infected
  • Subjects and caregivers are able to understand and cooperate with the study procedures and will attend all required follow-up visits

Key exclusion criteria

  • Medical instability limiting travel
  • Diseases or conditions that could interfere with compliance or study assessments
  • Current evidence or a history of SCC in the treatment area
  • Subjects actively receiving chemotherapy or immunotherapy at Visit 1 (Week 1)
  • Receipt of a skin graft in the past three (3) months
  • Pregnant or nursing women

Learn about VYJUVEK efficacy and safety

View Efficacy & Safety Data
INDICATION AND USAGE

VYJUVEK is a topical gel indicated for the treatment of wounds in adult and pediatric patients (from birth) with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following treatment. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.

Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.

Dispose all materials (e.g., vial, syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.


  • Please see Important Safety Information above and click here for full Prescribing Information.
REFERENCES:

1. VYJUVEK [prescribing information]. Krystal Biotech, Inc.; 2023.

2. Marinkovich MP, Paller AS, Guide SV, et al. Long-term safety and tolerability of beremagene geperpavec-svdt (B-VEC) in an open-label extension study of patients with dystrophic epidermolysis bullosa. Am J Clin Dermatol. Published online April 12, 2025. doi:10.1007/s40257-025-00942-y; https://doi.org/10.1007/s40257-025-00942-y

3. Guide SV, Gonzalez ME, Bagci IS, et al. Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med. 2022;387(24):2211-2219. doi:10.1056/NEJMoa2206663

IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE

VYJUVEK is a topical gel indicated for the treatment of wounds in adult and pediatric patients (from birth) with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following treatment. Wear protective gloves when assisting patients with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.

Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.

Dispose all materials (e.g., vial, syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.


  • Please see Important Safety Information above and click here for full Prescribing Information.
REFERENCES:

1. VYJUVEK [prescribing information]. Krystal Biotech, Inc.; 2023.

2. Marinkovich MP, Paller AS, Guide SV, et al. Long-term safety and tolerability of beremagene geperpavec-svdt (B-VEC) in an open-label extension study of patients with dystrophic epidermolysis bullosa. Am J Clin Dermatol. Published online April 12, 2025. doi:10.1007/s40257-025-00942-y; https://doi.org/10.1007/s40257-025-00942-y

3. Guide SV, Gonzalez ME, Bagci IS, et al. Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med. 2022;387(24):2211-2219. doi:10.1056/NEJMoa2206663