Abeona’s COL7A1 Gene Therapy Shows Robust Efficacy in The Lancet-Published RDEB Study

CLEVELAND – June 24, 2025 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that The Lancet has published full results from the pivotal Phase 3 VIITAL™ study of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

ZEVASKYN, the only FDA-approved product for RDEB wounds with a single application, demonstrated significant improvements in wound healing and pain reduction. RDEB is a rare genetic disorder causing severe, chronic skin wounds due to a lack of functional type VII collagen.

The VIITAL™ study, an intra-patient controlled trial, showed that 81% of ZEVASKYN-treated wounds healed by 50% or more from baseline at week 24, compared to 16% of control wounds (P<0.0001). Treated wounds also experienced a mean pain reduction of -3.1 versus -0.9 for controls (P=0.0002).

No serious ZEVASKYN-related adverse events or cases of squamous cell carcinoma (SCC) were reported, consistent with prior clinical experience.

“ZEVASKYN was well tolerated and significantly improved wound healing and pain in large chronic RDEB wounds after just a single treatment,” said Jean Tang, M.D., Ph.D., Principal Investigator and lead author.

“The publication in The Lancet marks a significant achievement as our U.S. launch of ZEVASKYN is underway, with the first patient expected to be treated in Q3 2025,” added Vish Seshadri, CEO of Abeona.

About ZEVASKYN™

ZEVASKYN is an autologous cell sheet-based gene therapy that incorporates the functional COL7A1 gene into a patient’s own skin cells via a retroviral vector. This enables treated wounds to produce functional type VII collagen, addressing the underlying cause of RDEB.