ZEVASKYN operates by incorporating the COL7A1 gene into a patient's skin cells, enabling the production of functional type VII collagen, which is crucial for skin integrity.

Adverse events were minimal, with procedural pain and itch occurring in fewer than 5% of patients, and no serious adverse events reported, indicating a favorable safety profile.

The U.S. FDA has approved ZEVASKYN™ (prademagene zamikeracel), marking it as the first and only cell-based gene therapy specifically designed to treat wounds in patients suffering from recessive dystrophic epidermolysis bullosa (RDEB).

This landmark approval is based on the pivotal Phase 3 VIITAL study, which demonstrated significant wound healing and pain reduction in patients aged six and older after just one treatment.

In this study, 81% of chronic wounds treated with ZEVASKYN showed over 50% healing at six months, in stark contrast to only 16% in control groups receiving standard care.

RDEB is caused by a defect in the COL7A1 gene, leading to fragile skin and severe wounds that can affect up to 80% of the body, with no existing cure prior to this therapy.

Dr. M. Peter Marinkovich emphasized the significance of this approval for EB patients, highlighting the extensive research that has culminated in this breakthrough.

The therapy is set to be available through Qualified Treatment Centers starting in the third quarter of 2025, priced at $3.1 million, providing nationwide access to patients.

Additionally, the study indicated pain reduction in patients evaluated six months post-treatment, further underscoring the therapy's benefits.

Abeona Therapeutics will hold a conference call on April 29, 2025, to discuss the implications of the FDA approval and outline the next steps for ZEVASKYN.

Experts in dermatology have praised the approval, noting its potential to greatly enhance the quality of life for RDEB patients and their families.

Abeona Therapeutics is also launching the Abeona Assist™ program to provide personalized support for patients and families navigating treatment with ZEVASKYN.