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Abeona Therapeutics® Announces Publication in The Lancet of Phase 3 VIITAL™ Study Data in Recessive Dystrophic Epidermolysis Bullosa
- RDEB is a lifelong debilitating, blistering skin disease associated with large and painful wounds that often remain open for years and cause significant
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"- RDEB is a lifelong debilitating, blistering skin disease associated with large and painful wounds that often remain open for years and cause significant clinical burden, including pain, itch, and risk of squamous cell carcinoma - - ZEVASKYN™ (prademagene zamikeracel) demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile in large chronic RDEB wounds - - ZEVASKYN is the first and only autologous cell-based gene therapy FDA-approved to treat RDEB wounds in adult and pediatric patients - CLEVELAND, June 24, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that The Lancet has published results from the pivotal Phase 3 VIITAL study (NCT04227106) evaluating the efficacy and safety of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). This article, titled, “Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa Wounds (VIITAL): A Two-Centre, Randomised, Open-Label, Intrapatient-Controlled Phase 3 Trial,” representing the primary publication of the full VIITAL study data, is now available online and will be published in a future print issue of The Lancet. Jean Tang, M.D., Ph.D., Professor of Dermatology, Stanford University School of Medicine, Principal Investigator of the ZEVASKYN Phase 3 VIITAL study and lead author of The Lancet publication said, \"People with RDEB endure incredibly fragile skin, leading to severe, painful wounds that can last for years, and lead to systemic complications impacting the length and quality of life. Our VIITAL study showed ZEVASKYN was well tolerated and significantly improved wound healing and pain in large chronic RDEB wounds after just a single treatment. We hope sharing these important findings, including our work published in The Lancet, raises awareness for RDEB and helps improve the lives of patients.\" RDEB, a rare genetic blistering disorder, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in both copies of the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which forms anchoring fibrils neces...