Abeona Therapeutics Inc. announced on June 24, 2025, that The Lancet has published results from the pivotal Phase 3 VIITAL™ study. This study evaluated the efficacy and safety of ZEVASKYN™ (prademagene zamikeracel) gene-modified cellular sheets for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The article, titled 'Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa Wounds (VIITAL): A Two-Centre, Randomised, Open-Label, Intrapatient-Controlled Phase 3 Trial,' represents the primary publication of the full VIITAL study data.
The VIITAL study demonstrated that ZEVASKYN was well-tolerated and significantly improved wound healing and pain in large chronic RDEB wounds after a single treatment. This scientific validation in a respected global medical journal is a significant achievement as Abeona's U.S. launch of ZEVASKYN is underway. The publication highlights ZEVASKYN as the first and only autologous cell-based gene therapy FDA-approved to treat RDEB wounds.
The study focused on 43 pairs of large chronic wounds across 11 patients, showing significant healing and pain reduction at six months. This publication reinforces the clinical evidence supporting ZEVASKYN's potential to provide long-term healing and pain reduction for patients suffering from this debilitating skin disease, further supporting its commercial adoption.
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