Designed for durable type VII collagen expression at the application site1

ZEVASKYN (ZEE-vah-skin) is made from patients’ own skin cells that are genetically modified with copies of the functional COL7A1 gene1

  • Autologous keratinocytes are isolated from skin punch biopsies, then transduced ex vivo with a retroviral vector containing the full-length COL7A1 gene
  • The resulting gene-modified cellular sheets express functional type VII collagen (C7) protein
  • Stable integration of the COL7A1 gene is maintained through cell division at the treated site even after ZEVASKYN application
  • Durable C7 expression results in the formation of anchoring fibrils (AFs)1,2

Long-term presence of C7 and anchoring fibrils at treated sites1

Baseline2*

Baseline absence of anchoring fibrils

3 months2*

3-months presence of anchoring fibrils at treated site

12 months2*

12-months presence of anchoring fibrils at treated site

24 months3*

24-months presence of anchoring fibrils at treated site
  • *Immunofluorescence images.
Anchoring fibrils: C7 at the dermal-epidermal junction, resulting in AF formation
Anchoring fibrils: C7 at the dermal-epidermal junction, resulting in AF formation

Patients treated with ZEVASKYN were assessed for presence of both C7 and AFs.‡

  • At 3 months, 86% of patients (6/7) were positive for both C7 and AFs
  • At 6 months, 71% of patients (5/7) were positive for both C7 and AFs
  • At 1 year, 43% of patients (3/7) were positive for both C7 and AFs
  • At 2 years, 67% of patients (2/3) were positive for both C7 and AFs§

Assessment was elective and performed periodically because each test required a biopsy of healed skin.

  • ‡In the Phase 1/2a study, C7 expression was assessed by immunofluorescence microscopy (negative cofactor 2 domain of C7 using the LH24 antibody) and anchoring fibrils were assessed by immunoelectron microscopy.
  • §One patient was positive for both C7 and AFs; one patient was positive only for C7 (as biopsy to assess AF was not obtained).

Discover what durable healing can look like with ZEVASKYN—even in tough RDEB wounds

Discover before and after images of wounds treated with ZEVASKYN

Individual results may vary.

Example of wound before treatment with ZEVASKYN

Efficacy

References: 1. ZEVASKYN™ (prademagene zamikeracel) Prescribing Information. Cleveland, OH: Abeona Therapeutics Inc; 2025. 2. Siprashvili Z, Nguyen NT, Gorell ES, et al. JAMA. 2016;316(17):1808-1817. doi:10.1001/jama.2016.15588 3. Eichstadt S, Barriga M, Ponakala A, et al. JCI Insight. 2019;4(19):e130554. doi:10.1172/jci.insight.130554

Indication

ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

  • Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Monitor for signs and symptoms of hypersensitivity reactions such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis and treat according to standard clinical practice.
  • Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. Monitor patients lifelong after treatment for the development of malignancies. In the event that a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236.
  • Transmission of infectious disease or agents may occur with ZEVASKYN because it is manufactured using human- and bovine-derived reagents, which are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.
  • The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.

Please see full Prescribing Information.

Indication

ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

  • Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Monitor for signs and symptoms of hypersensitivity reactions such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis and treat according to standard clinical practice.
  • Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. Monitor patients lifelong after treatment for the development of malignancies. In the event that a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236.
  • Transmission of infectious disease or agents may occur with ZEVASKYN because it is manufactured using human- and bovine-derived reagents, which are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.
  • The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.

Please see full Prescribing Information.

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ZEVASKYN, Abeona Assist, and the related logos are trademarks of Abeona Therapeutics Inc. All other trademarks are the property of their respective owners.

© 2025 Abeona Therapeutics Inc. All rights reserved. US-COM-ZEV-240021  05/25