Abeona Expands ZEVASKYN Network as RDEB Launch Gains Momentum

Abeona is building a commercial infrastructure for ZEVASKYN, its one-time, patient-specific gene therapy for chronic wounds associated with recessive dystrophic epidermolysis bullosa. The therapy’s 84-hour shelf life and specialized manufacturing require close coordination among patients, surgeons and treatment centers. The qualified treatment-center network has grown to seven sites, covering regions containing about 40% of the addressable patient population. Physicians and centers have identified more than 100 potential candidates, although management said completed treatments—not biopsies or manufacturing activity—are the key commercial metric. Management said more than 95% of commercially insured lives have ZEVASKYN coverage, while manufacturing turnaround is typically 23–26 days. Abeona expects early demand to come mainly from new patients, with repeat treatment potentially occurring after six months to a year and free-cash-flow positivity requiring more than three patients treated per month. Abeona Therapeutics NASDAQ: ABEO executives outlined the early commercial rollout of ZEVASKYN, an autologous cell sheet-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), during the Morgan Stanley Global Healthcare Conference. Management emphasized that the launch requires a longer foundation-building period than a conventional drug because of the therapy’s individualized manufacturing process, limited shelf life and specialized treatment-center requirements. President and Chief Executive Officer Vish Seshadri said the company received its first product approval last year and treated its first commercial patient with ZEVASKYN in December. He described the transition from a development-stage biotechnology company to a commercial organization as a cultural shift, with Abeona expanding from roughly 80 to 90 research-and-development employees two to three years ago to about 250 employees supporting manufacturing and supply operations. Seshadri described RDEB as a genetic connective-tissue disorder in which patients lack a functional gene for collagen VII, a protein that helps hold skin layers together. The resulting loss of skin integrity can lead to chronic wounds, blistering, infections, sepsis and other complications, he said. Patients may require wound-dressing changes several times weekly, with each session lasting six to seven hours, according to Seshadri. Historically, patients have relied primarily on antibiotics and bandage changes, he said. More recently, genetic medicines have entered the treatment landscape, including topical therapies designed to supply the relevant gene on a temporary basis. ZEVASKYN uses a patient’s own cells, which are modified to produce collagen VII and applied as sheets to wounds in a one-time treatment for a given wound. Seshadri said Abeona has clinical data extending as far as 12 years from a single application, including data presented at the Society for Investigative Dermatology conference. In discussing another therapy in the market, Krystal Biotech’s VYJUVEK, Seshadri said the products are intended to serve different needs rather than compete as mutually exclusive treatments. He characterized VYJUVEK as a weekly treatment and said ZEVASKYN may be particularly suited for patients with large, contiguous chronic wound areas. Each ZEVASKYN sheet covers approximately 40 square centimeters, and a batch can contain up to 12 sheets, he said. Seshadri added that commercially treated ZEVASKYN patients have largely previously received VYJUVEK, underscoring what he described as remaining unmet need among RDEB patients.