Histogenics completed patient enrollment of its NeoCart® Phase III clinical trial, which is being conducted under a Special Protocol Assessment with FDA.
The 245-patient trial is evaluating pain and function improvement of patients treated with NeoCart tissue engineered implant compared to microfracture. Histogenics expects to report top-line 1-year superiority data from the trial in 3Q18, followed by a Biologics License Application, potential approval and 2H19 market launch.
Results from Phase I and Phase II study indicated that NeoCart is a safe, effective treatment for articular cartilage lesions through 5-year follow-up. The Phase III trial update follows the announcement in May that Histogenics successfully completed consultations with Japan Pharmaceuticals and Medical Devices Agency regarding the regulatory path for NeoCart.
Sources: Histogenics; ORTHOWORLD Inc.
Photo courtesy of Histogenics