Abeona Therapeutics Expands Access to Innovative Skin Disorder Treatment

Abeona Therapeutics Collaborates with Lurie Children’s Hospital

Abeona Therapeutics Inc. and Ann & Robert H. Lurie Children’s Hospital have joined forces to pave the way for groundbreaking therapies for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB). This skin disorder is known for its severe and painful injuries that significantly affect life quality. With the recent activation of Lurie Children’s as the first Qualified Treatment Center for ZEVASKYN, patients can now look forward to innovative care specifically designed for their needs.

The Launch of ZEVASKYN Treatment

As the first and only autologous cell-based gene therapy for the treatment of RDEB, ZEVASKYN signifies a major milestone in therapeutic advancements. This innovative therapy includes gene-modified cellular sheets, which will directly address the painful wounds associated with this debilitating disorder. Patients are expected to start receiving treatments in the third quarter of the upcoming year, making this a pivotal time in regenerative medicine.

ZEVASKYN's Approval and Availability

On April 29, 2025, the U.S. Food and Drug Administration (FDA) granted approval for ZEVASKYN, affirming its vital role in treating wounds in both adult and pediatric patients with RDEB. The characteristic hallmark of RDEB is the absence of functioning type VII collagen due to defects in the COL7A1 gene, leaving patients vulnerable to suffering from chronic wounds. The introduction of ZEVASKYN presents the first-ever FDA-approved option to effectively address these issues with a single application.

Expert Opinions on the Collaboration

Experts at Lurie Children’s Hospital are excited about the possibilities ZEVASKYN brings for patient care. Dr. Amy Paller, who leads the epidermolysis bullosa research program, emphasized the hospital's expert reputation in treating this condition. With the integration of gene-corrected cellular sheets, this therapy offers hope for long-term wound healing and significant pain relief.

Lurie Children's Role in Genetic Skin Disorders

Over the past three decades, Lurie Children’s has established itself as a leader in treating genetic skin diseases. With more than 150 patients affected by epidermolysis bullosa, the hospital is recognized for its commitment to cutting-edge research and clinical applications. Their ongoing participation in the EB Clinical Research Consortium underscores their dedication to improving treatment strategies and outcomes for patients.

Abeona's Patient Support Commitment

Abeona is deeply committed to ensuring all eligible patients have access to ZEVASKYN. This includes the effective utilization of their Abeona Assist program, which serves to guide patients and families through the complexities of accessing treatment. They provide valuable support regarding insurance benefits, financial assistance, and logistical planning necessary for treatment.

Additional Gene Therapy Advancements

Since 2019, Lurie Children’s has developed a robust program offering FDA-approved gene therapies for various diseases, broadening their scope of treatment options. The introduction of ZEVASKYN is set to enhance these efforts, representing their tenth gene therapy option, further solidifying their role in fighting genetic disorders.

Understanding Recessive Dystrophic Epidermolysis Bullosa

Recessive dystrophic epidermolysis bullosa (RDEB) isn’t merely a skin condition—it’s a life-altering disease. Characterized by debilitating wounds and pain, RDEB presents severe challenges that significantly diminish quality of life. Patients with RDEB face the repercussions of defective COL7A1 genes, resulting in continuous skin fragility and vulnerability to infections. ZEVASKYN is engineered to rectify this issue by introducing functional COL7A1 genes into the patient's own skin cells, thus facilitating skin healing.

The Future of Gene Therapy

The introduction of ZEVASKYN represents a groundbreaking step in the realm of gene therapy and demonstrates Abeona's commitment to innovation in medical treatment. As research evolves, so too does the potential for creating life-enhancing therapies for individuals living with severe genetic conditions. With their manufacturing facility in Cleveland, Abeona has positioned itself as a leader in gene therapy, working passionately towards evolving treatment landscapes for various diseases.

Frequently Asked Questions

What is ZEVASKYN?

ZEVASKYN is an autologous cell-based gene therapy clinically approved for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).

Who can access ZEVASKYN treatments?

Eligible patients diagnosed with RDEB can access ZEVASKYN through specialized Qualified Treatment Centers like Lurie Children’s Hospital.

What does the Abeona Assist program offer?

Abeona Assist provides personalized support, including guidance on insurance benefits, financial assistance, and logistical assistance for patients undergoing ZEVASKYN treatment.

How is RDEB treated with ZEVASKYN?

ZEVASKYN works by incorporating the functional COL7A1 gene into the patient’s skin cells, promoting the production of functional type VII collagen essential for healthy skin.

What makes Lurie Children’s Hospital a pivotal partner?

Lurie Children’s Hospital has a longstanding expertise in treating genetic skin diseases and is recognized for its cutting-edge research and clinical care in this field.

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