Now FDA Approved
Geovanna, a ZEVASKYN patient at age 8
Now FDA Approved
Strong Bonds Stand the Test of Time
Durable wound healing with a single surgical application—even in tough RDEB wounds1
- 81% of ZEVASKYN-treated wounds (35/43) achieved 50% or more healing vs 16% of matched control wounds (7/43; P<0.0001)
ZEVASKYN (ZEE-vah-skin) is the first and only autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).1,2 Made from the patient’s own skin cells that have been gene-modified to express functional type VII collagen, ZEVASKYN sheets help address the genetic cause of RDEB in treated wounds. Up to 12 credit card–sized sheets (41.25 cm2 each) are applied to cover multiple individual wounds or joined together to cover larger areas.2
ZEVASKYN achieved significant healing as evaluated at week 24 in a Phase 3 study1
- Multicenter, randomized trial evaluated 86 large, chronic wounds in 11 patients with RDEB
- 43 ZEVASKYN-treated vs 43 matched control wounds treated with standard of care*
- Median patient age: 21 years (range 6-40 years)3
- Median wound duration: 5 years (range 6 months-21 years)
- Coprimary endpoints:
- 81% of ZEVASKYN-treated wounds (35/43) achieved 50% or more healing vs 16% of matched control wounds (7/43; P<0.0001)†
- ~3.5x reduction in pain in ZEVASKYN-treated wounds (-3.1) vs matched control wounds (-0.9; P=0.0002)‡
*Bandages and palliative care.3
†Investigator-assessed.
‡Patient-reported, following wound dressing change, using the Wong-Baker FACES® Pain Rating Scale (scale 0-10).1,3
Example of a wound before and after treatment with ZEVASKYN4
Individual results may vary.
Example of wound healing after long-term follow-up2
Individual results may vary.
- Study design: Open-label, single-arm, single-center1,5
- Patient population: 7 patients with RDEB; 38 chronic wounds assessed5
- Follow-up duration: Median 6.9 years (range 4-8 years); planned follow-up of 15 years5
I was very excited, and I was showing it off to everyone, and I was taking pictures, and I was looking in the mirror, and I was checking it out, and I was doing everything I could to see how it looked, and I was trying to move around a little bit, and I was just thrilled with the outcome.”
Abeona Assist is your dedicated support partner every step of the way
Abeona Assist is a personalized support program providing comprehensive resources for patients, caregivers, and healthcare professionals along the ZEVASKYN treatment pathway. Whether you are exploring ZEVASKYN treatment, have questions, or are ready to take the next steps, contact a Patient Navigator today for more information.
Available Monday–Friday
9:00 AM–6:30 PM (ET)
9:00 AM–6:30 PM (ET)
ZEVASKYN Qualified Treatment Centers§
ZEVASKYN must be surgically applied to wounds by a dedicated care team at a ZEVASKYN Qualified Treatment Center.1 Abeona Therapeutics is in the process of partnering with specialized EB centers situated across the US. For more information call 1-855-ABEONA-1.
EB=epidermolysis bullosa.§ZEVASKYN Qualified Treatment Centers are independently owned and operated. Abeona Therapeutics does not oversee any treatment centers or the medical care they provide.
The benefit of [ZEVASKYN] is a one-time therapy so it is really helpful; you just have to be patient with the process.”
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What is ZEVASKYN?
ZEVASKYN™ (prademagene zamikeracel) is a type of gene therapy made from your own skin cells that is surgically applied to treat wounds in both children and adults who have recessive dystrophic epidermolysis bullosa (RDEB).
Important Safety Information
- Serious allergic reactions to ZEVASKYN can occur. Get medical help right away if you or your child experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
- There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
- ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
- The most common side effects are pain from the procedure and itching.
This is not a complete list of side effects. Call your care team for medical advice about side effects. You may report side effects to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Post-Application Care
- You may feel pain or itching at the treated area as it heals. Contact your doctor if you have: fever, increased drainage, worsening pain or swelling, or any other symptoms at or near the treated area.
- Do not disturb the surgical dressing for 5—10 days, unless your doctor tells you otherwise.
- Keep the dressing(s) dry. Do not soak the treated area(s) in water (like in a bath or pool) until the gauze backing falls off of the treated area(s), approximately 2—3 weeks after the surgery.
Product Manufacturing
- ZEVASKYN is made from your own skin cells. In rare cases, the manufacturing process may not work. If this happens, your doctor may suggest taking another skin biopsy to repeat the manufacturing process.
Please see full Prescribing Information.
What is ZEVASKYN?
ZEVASKYN™ (prademagene zamikeracel) is a type of gene therapy made from your own skin cells that is surgically applied to treat wounds in both children and adults who have recessive dystrophic epidermolysis bullosa (RDEB).
Important Safety Information
- Serious allergic reactions to ZEVASKYN can occur. Get medical help right away if you or your child experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
- There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
- ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
- The most common side effects are pain from the procedure and itching.
This is not a complete list of side effects. Call your care team for medical advice about side effects. You may report side effects to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Post-Application Care
- You may feel pain or itching at the treated area as it heals. Contact your doctor if you have: fever, increased drainage, worsening pain or swelling, or any other symptoms at or near the treated area.
- Do not disturb the surgical dressing for 5—10 days, unless your doctor tells you otherwise.
- Keep the dressing(s) dry. Do not soak the treated area(s) in water (like in a bath or pool) until the gauze backing falls off of the treated area(s), approximately 2—3 weeks after the surgery.
Product Manufacturing
- ZEVASKYN is made from your own skin cells. In rare cases, the manufacturing process may not work. If this happens, your doctor may suggest taking another skin biopsy to repeat the manufacturing process.
Please see full Prescribing Information.
References: 1. ZEVASKYN™ (prademagene zamikeracel) Prescribing Information. Cleveland, OH: Abeona Therapeutics Inc; 2025. 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. Clinical study report EB-101-CL-301. Abeona Therapeutics Inc. 4. Data on file. Abeona Therapeutics Inc. 5. Clinical study report 14563/31095. Abeona Therapeutics Inc.