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About RDEB

How ZEVASKYN Works

Efficacy

Phase 3 (VIITAL Study)

  • Study design

  • Healing at week 24

  • Before and after images

Phase 1/2a

  • Pain/itch reduction

  • Long-term follow-up images

Safety

Treatment Overview

Support & Resources

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  • ZEVASKYN Qualified Treatment Centers

  • Treatment Process at a Glance

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Learn how ZEVASKYN—and a single surgical application—can help your patients with RDEB

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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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