Zevaskyn

Zevaskyn (prademagene zamikeracel) is an autologous cell-based gene therapy used to treat chronic skin wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic blistering skin disorder. Patients with RDEB are unable to make type VII collagen, which results in skin that is fragile and blisters easily, with wounds that may fail to heal and increase the risk of systemic infection.

Zevaskyn is an autologous cell-based gene therapy, autologous means the treatment is made specifically for you from your own cells.

Zevaskyn works by using the patient’s own skin cells, which are genetically modified so they can produce working type VII collagen. These corrected cells are grown into thin sheets and surgically placed over chronic wounds, where they supply the missing collagen and help the skin layers bond and heal.

Zevaskyn's FDA approval for the treatment of wounds in recessive dystrophic epidermolysis bullosa (RDEB) in adult and pediatric patients. FDA approval was granted on April 28, 2025, after positive results from clinical trials.

In the Phase 3 VIITAL study (NCT04227106), using a single application of Zevaskyn to chronic RDEB wounds after 24 weeks:

• 81% of treated wounds achieved ≥ 50% healing at six months versus 16% with standard of care (P<0.0001),
• and meaningful pain reduction

Long-term durability was demonstrated in a Phase 1/2a study (NCT01263379), where a single surgical application was associated with sustained improvement at treated sites over a median follow-up of 6.9 years (range 4–8 years) in 38 wounds across 7 patients.

Recessive dystrophic epidermolysis bullosa (RDEB) is a rare inherited condition that affects the tissue that holds the skin together. It is caused by a change in the COL7A1 gene, which means the body cannot make enough working type VII collagen, a protein that acts like “anchors” between the top and deeper layers of the skin.

Without this anchoring type VII collagen, the skin becomes extremely fragile and blisters or tears with very minor friction or injury. This leads to wounds that may keep opening and closing, or sometimes do not heal at all. Severe wounds can be large and very painful, and they can increase the risk of serious, body-wide (systemic) infections.

Zevaskyn is applied in a medical setting by specially trained healthcare professionals.

Before treatment, your doctor will take a sample of your skin, which is sent to a laboratory where the skin cells will be used to make Zevaskyn.

You will not receive the medicine on the same day your skin cell sample is taken. It will take time to process your skin cells, and your doctor will determine your treatment schedule.

Zevaskyn Treatment Process

• Biopsy: Two small skin samples (8mm) are taken from the patient.
• Gene Modification: Cells (keratinocytes) from the biopsy are sent to Abeona, where they are genetically modified to carry the correct gene for collagen VII.
• Cell Expansion: These modified cells are grown in a lab into skin-like sheets (about credit card size) over ~25 days.
• Application: Up to 12 sheets are surgically applied to wounds in one session. It may not be possible to apply the medicine to all wounds with each treatment.
• Healing: A dressing is left undisturbed for 5-10 days to allow the sheets to integrate and heal the wound. Keep the dressing(s) dry. You should not soak the treated area(s) in water, such as in a bath, hot tub, or swimming pool, until the gauze backing naturally comes off, which is usually about 2 to 3 weeks after surgery.

Note: Zevaskyn is created using your own skin cells and in rare cases, the manufacturing process may not be successful. If this occurs, your doctor may recommend taking another skin sample (biopsy) to try making the treatment again.

Serious allergic reactions to Zevaskyn can happen. Seek emergency medical help right away if you or your child develops symptoms such as itching, swelling, hives, trouble breathing, a runny nose, watery eyes, or nausea. In rare cases, a severe allergic reaction called anaphylaxis may occur.

Risk of cancer. Using Zevaskyn may increase your risk of developing cancer. Ask your doctor about your individual risk and what symptoms to watch for.

Risk of infection. Zevaskyn is made using human and animal products. They may contain viruses or other infectious agents. The products are tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

This treatment should not be used if you have a certain gene type. Ask your doctor if you have any questions.

Tell your doctor if you have or have ever had:

• an active or recent infection; or
• use other medications.

Using Zevaskyn may increase your risk of developing cancer. Ask your doctor about your individual risk and what symptoms to watch for.

Zevaskyn is made using human and animal products. They may contain viruses or other infectious agents. The products are tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

It is not known if Zevaskyn will harm an unborn baby. Use birth control during treatment with Zevaskyn and tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Common Zevaskyn side effect may include:

• procedure pain; or
• itching.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Zevaskyn may cause serious side effects. Call your doctor at once if you have:

• signs of infection -
• fever, chills, sore throat, body aches, unusual tiredness, loss of appetite; or
• increased pain, swelling, oozing, or skin changes around the treatment site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• The recommended dose of this product is based on the surface area of the wound(s).
• One sheet of Zevaskyn covers an area of 41.25 cm2.
• Up to twelve sheets may be manufactured from the patient biopsies and supplied for potential use.

For autologous topical application on wounds only. Autologous means the treatment is made from your own cells that are modified and then given back to you to help fix a problem with the COL7A1 gene. You doctor will verify the patient’s identity before to Zevaskyn application. Zevaskyn should not be applied if the information on the patient-specific label(s) does not match the intended patient.

Call your doctor for instructions if you miss an appointment to receive Zevaskyn.

Avoid letting treated areas come in contact with water until the gauze backing falls off (usually within 2 to 3 weeks after application).

Tell your doctor about all your other medicines, especially:

• antibiotic such as vancomycin or amikacin.

Other drugs may affect Zevaskyn, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

HCPs and patients often use the Zevaskyn Prescribing Information for more detailed information about this medicine. The Prescribing Information contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information is sometimes called Zevaskyn Package Insert or FDA label.