Opus Genetics (IRD) filed a revised investor presentation to correct a self-described "immaterial error" in its previously announced clinical data for the Phase 1/2 trial of OPGx-BEST1, a gene therapy for BEST1-related retinal diseases. The correction pertains to the calculation of visual acuity changes in Cohort 1 participants. The reissued presentation reaffirms positive safety and efficacy signals from the trial.
Key Details
- Correction Details: The revision corrects an error in translating logMAR visual acuity into ETDRS letters on a single slide, providing updated 3-month visual acuity changes for the five participants in Cohort 1.
- Positive Trial Data: The therapy was well-tolerated with no serious adverse events. 75% of evaluable participants (3 of 4) met the FDA-aligned microperimetry endpoint, and 80% of participants (4 of 5) showed structural improvements.
- Program Updates & Timeline: The higher-dose Cohort 2 is now fully enrolled with 8 participants. The company expects to report 6-month data for Cohort 1 and 3-month data for Cohort 2 in Q2 2027, with plans to begin a pivotal trial in 2027.