Abeona Initiates First Commercial Treatment of Zevaskyn for RDEB

Abeona Therapeutics has announced the first commercial patient treatment of prademagene zamikeracel (Zevaskyn), an FDA-approved therapy for adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The first patient was treated at Lucile Packard Children’s Hospital Stanford in Palo Alto, California. The first treatment follows Zevaskyn’s FDA approval in April 2025 as the first autologous, gene-modified cellular sheet designed to address chronic and debilitating RDEB wounds.¹

“Patients with rare genetic skin disorders have longed for highly effective therapies for decades. Recessive dystrophic epidermolysis bullosa is a devastating genetic skin disorder with high unmet need. Patients lack functional collagen VII and it leads to poor healing wounds," Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, and Dermatology Times Editor in Chief, said in an exclusive statement.

He continued, "It is wonderful to see the new FDA-approved prademagene zamikeracel, a cell-sheet based collagen VII gene therapy, administered to its first patient. This represents a milestone for RDEB patients, and I expect it is just the beginning of more innovative therapies coming into the clinic for patients with rare genetic skin diseases.”

RDEB is a result of biallelic pathogenic variants in COL7A1, preventing the production of functional type VII collagen and disrupting the formation of anchoring fibrils. The absence of dermal–epidermal adhesion leads to extreme skin fragility, chronic erosions, scarring, and life-threatening systemic complications.

According to Abeona’s Chief Executive Officer, Vish Seshadri, “Treating our first patient is a proud moment for Abeona and a testament to the tireless resolve of our team. We are humbled to bring Zevaskyn to the RDEB community and grateful to our growing network of Qualified Treatment Centers. Momentum is building, with additional patients already scheduled for treatment in the new year.” Zevaskyn’s debut in a commercial setting signals a new treatment era for patients limited to supportive wound care and symptomatic management.¹

Joyce Teng, MD, PhD, professor of dermatology at Stanford Medicine and chief of pediatric dermatology at Stanford Medicine Children’s Health, emphasized the ongoing clinical need, stating, “We continually pursue new therapies to support patients enduring the lifelong pain and extensive wound care that RDEB demands, and work to provide care and hope to patients and families.”

Zevaskyn introduces a functional COL7A1 gene into autologous keratinocytes ex vivo via a replication-incompetent retroviral vector. These corrected cells are expanded into epithelial sheets that are surgically applied to wounds, enabling production of type VII collagen at the treatment site. Clinical data have shown durable wound closure and reduced pain following a single application.^1,2

“The science really works, even for such a rare disease as RDEB. We use a retrovirus to insert the collagen VII gene into the patient’s cells. These corrected cells are then grown into skin grafts and surgically applied to the patient’s wounds. Because the grafts come from the patient’s own cells, immunosuppressive drugs are not needed, which reduces the risk of adverse effects. This demonstrates that dermatology can meaningfully improve the lives of patients with some of the most challenging skin diseases,” Tang told Dermatology Times in a previous interview.²

As clinicians integrate gene-corrected cell sheet therapy into RDEB management, logistical coordination remains essential. Abeona Assist®, the company’s support program, offers guidance on insurance navigation, financial assistance, and travel coordination for eligible patients.

References

1. Abeona Therapeutics announces first patient treatment with ZEVASKYN gene therapy. News release. Abeona Therapeutics. December 8, 2025. Accessed December 8, 2025. https://investors.abeonatherapeutics.com/press-releases/detail/330/abeona-therapeutics-announces-first-patient-treatment
2. Tang J, Dermatology Times staff. Jean Tang, MD, PhD, reflects on FDA approval of pz-cel for EB. Dermatology Times. August 19, 2025. Accessed December 8, 2025. https://www.dermatologytimes.com/view/jean-tang-md-phd-reflects-on-fda-approval-of-pz-cel-for-eb