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# Abeona Therapeutics, FDA Agree on Cell Therapy Endpoints
- URL: https://www.fdaweb.com/abeona-therapeutics-fda-agree-on-cell-therapy-endpoints/
- Published: 2021-01-27T12:00:00.000Z
- Updated: 2026-09-14T16:44:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148542

Abeona Therapeutics says it has completed a Type B meeting with FDA on co-primary endpoints for its planned pivotal Phase 3 VIITAL study of EB-101 in recessive dystrophic epidermolysis bullosa (RDEB), which is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. Those with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen to anchor the skin’s dermal and epidermal layers, according to the company. EB-101 is described as an autologous, gene-corrected cell therapy.

In the trial, Abeona says it will enroll between 10 to 15 patients with RDEB with about 35 large chronic wound sites treated in total. The co-primary endpoints of the study are: (**1**) the proportion of RDEB wound sites with greater than or equal to 50% healing from baseline, comparing treated with untreated wound sites at Week 24 as determined by an investigator assessment; and (**2**) pain reduction associated with wound dressing change assessed by the mean differences in scores of the Wong-Baker FACES scale between treated and untreated wounds at Week 24.

Earlier Phase 1/2a clinical trial data showed wound healing of 50% or greater following EB-101 treatment in patients, the company says. RDEB was also associated with no pain at treated sites at three, four and five years post-treatment, compared with the presence of pain in 53% of wound sites at baseline, it adds.

EB-101 is described as an autologous, gene-corrected cell therapy.