RDEB: A serious genetic disease with significant unmet need for long-lasting wound healing

RDEB wounds cause significant clinical burden, including pain, itch, and risk of SCC1

Genetic mutation

RDEB is caused by mutations in both copies of the COL7A1 gene1

Lack of type VII collagen

As a result, cells are unable to express functional type VII collagen protein, which is needed to form anchoring fibrils that bond the epidermis to the dermis1,2

Anchoring fibrils deficit

Lack of anchoring fibrils leads to fragile skin that blisters easily, and patients suffer from years of painful wounds and itch1,3

Severe complications

RDEB wounds can lead to serious life-threatening complications. Patients have up to a 90% risk of developing SCC4

For patients with RDEB, wounds can cover significant body surface area and are a constant source of severe pain and itch1

Untreated RDEB wounds on the back
RDEB wounds on patient's torso
  • Photos are of 2 different patients prior to treatment with ZEVASKYN.5
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There is a critical unmet need for treatments that provide durable wound healing and pain and itch reduction1

  • RDEB=recessive dystrophic epidermolysis bullosa; SCC=squamous cell carcinoma.

Discover before and after images of wounds treated with ZEVASKYN

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RDEB wound at back before treatment
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References: 1. Tang JY, Marinkovich MP, Lucas E, et al. Orphanet J Rare Dis. 2021;16(1):175. doi:10.1186/s13023-021-01811-7 2. So JY, Nazaroff J, Iwummadu CV, et al. Orphanet J Rare Dis. 2022;17(1):377. doi:10.1186/s13023-022-02546-9 3. Eichstadt S, Barriga M, Ponakala A, et al. JCI Insight. 2019;4(19):e130554. doi:10.1172/jci.insight.130554 4. Fine JD, Johnson LB, Weiner M, Li K-P, Suchindran C. J Am Acad Dermatol. 2009;60(2):203-211. doi:10.1016/j.jaad.2008.09.035 5. Data on file. Abeona Therapeutics Inc.

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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