Thursday, September 10, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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The DMC Recommends Continuing The GARDian Trial. Data Monitoring Committee (DMC) has completed its planned interim analysis of the Phase 2/3 GARDian trial of OCU410ST in Stargardt disease. The analysis included 26 patients out of the planned enrollment of about 50, evaluating 16 treated patients and 10 controls. The DMC recommended continuing the trial as planned, with an evaluation of the entire patient population at 8 months after treatment. We believe the disclosure has led to misinterpretation of the recommendation.
The Evaluation Included Just Half The Enrollment In An Orphan-Sized Trial. Stargardt is an Orphan disease with a Phase 2/3 trial based on a small enrollment of about 50 patients. While this helps enrollment, each patient’s data has a larger impact than in larger trials.
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