Established safety profile

ZEVASKYN safety in 43 large, chronic wounds in 11 patients in the VIITAL Phase 3 study1,2

  • Most common adverse reactions (incidence ≥5% of patients):
    • Procedural pain: 3/11 patients (27%)
    • Pruritus: 1/11 patients (9%)
  • No grade 3 adverse reactions were reported2

Additional long-term safety data from clinical trials2,3

  • In 99 large, chronic ZEVASKYN-treated wounds across 18 patients
    • Median follow-up is 38.2 months (range 12 months–11 years)4,5
  • No cases of SCC were reported in ZEVASKYN-treated wounds
    • SCC was observed in non-ZEVASKYN–treated sites in 4 patients5
  • No instances of RCR positivity were reported*
Gus, smiling with his daughter, Noelle, who received ZEVASKYN treatment

And seeing these areas that were problematic, that hadn’t healed for years, are now staying, you know, wound-free for a while. And she’s like, wow, this is amazing. You know, so it’s a tough thing to go through. But the rewards are there.”

Learn about Noelle's journey through treatment Right-open Right-open
  • RCR=replication-competent retrovirus; RDEB=recessive dystrophic epidermolysis bullosa; SCC=squamous cell carcinoma.
  • *Based on 102 serum samples.5

Discover before and after images of wounds treated with ZEVASKYN

View before and after images Right-open Right-open

Individual results may vary.

Baseline RDEB wound at the back before treatment with ZEVASKYN
Treatment Overview Right-open Right-open

References: 1. ZEVASKYN™ (prademagene zamikeracel) Prescribing Information. Cleveland, OH: Abeona Therapeutics Inc; 2025.
2. Clinical study report EB-101-CL-301. Abeona Therapeutics Inc. 3. Clinical study report 14563/31095. Abeona Therapeutics Inc. 4. EB-101 SCS 120-Day Safety Update, Table 14. Abeona Therapeutics Inc. 5. Villanueva-Gaona R, Gorell ES, Marinkovich M, et al. J Invest Derm. 2024;144(8):S171. doi:10.1016/j.jid.2024.06.1149

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