Abeona Therapeutics Inc receives FDA approval for ZEVASKYN™ cell-based gene therapy

On 29th April 2025, the U.S. Food and Drug Administration (FDA) approved a new treatment called ZEVASKYN™ (pronounced ZEE-vah-skin) for adults and children with recessive dystrophic epidermolysis bullosa (RDEB). Developed by Abeona Therapeutics, ZEVASKYN™ is the first and only is the first and only gene therapy that uses a patient’s own skin cells (autologous cell-based gene therapy) to help treat the condition. The treatment involves taking a patient's own skin cells, correcting the genetic defect in the laboratory, and then grafting the modified cells back onto the patient's wounds. This approach promotes durable skin adhesion and wound healing.

The FDA's approval was based on the pivotal Phase 3 VIITAL™ study, which showed significant wound healing and pain reduction. Out of 43 large and chronic wounds treated, 81 percent of wounds showed 50 percent or more healing after six months. ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application.

“Today’s approval of ZEVASKYN represents a pivotal moment in the treatment of RDEB, answering the call of people living with the clinical, economic, and human impact of this devastating disease,” said Vish Seshadri, Ph.D., M.B.A., Chief Executive Officer of Abeona.

“We have heard from the RDEB community that there is a persistent unmet need to reliably address RDEB wounds, especially those that are chronic and prone to infection. Through a single surgical application, ZEVASKYN can now offer people with RDEB the opportunity for wound healing and pain reduction in even the most severe wounds, as evidenced by the results from our pivotal Phase 3 study.”

Marissa Perman, MD, Section Chief of Dermatology and Director of the Epidermolysis Bullosa Multidisciplinary Clinic at Children's Hospital of Philadelphia and paid consultant to Abeona added: “We are grateful to the dedicated scientists whose work over the past decade made the development of ZEVASKYN possible. Having a new, uniquely differentiated, gene therapy for our patients with RDEB is a significant milestone in helping these special patients live fuller, pain-free and itch-free lives with less wounds. As a physician caring for patients with RDEB, I look forward to the opportunity to see this treatment in our practice.”

For more information on ZEVASKYN and its availability, visit Abeona Therapeutics' official website here.​