Opus Genetics, Inc. filed a Form 8-K on September 11, 2026, furnishing a revised data presentation that corrects an error in visual acuity reporting from Cohort 1 of its Phase 1/2 clinical trial of OPGx-BEST1 in patients with BEST1-related retinal diseases.

Key Highlights

  • Correction filed: The revised presentation fixes what the company described as "an immaterial error in the translation of logMAR visual acuity into ETDRS letters," affecting Slide 15 of the original deck.
  • Original presentation date: The initial data presentation was used at an investor conference on September 9, 2026, and furnished via a separate Current Report on that date.
  • Participant-level ETDRS changes reported: Corrected three-month changes from baseline are disclosed for five participants (101-101, 101-104, 102-101, 102-102, and 101-106) in both treated and fellow eyes.
  • Additional content added: High-resolution microperimetry grid images for baseline and three months were added to the appendix for each participant, with individual loci data available for three participants.
  • Signing officer: The filing was signed by Dr. George Magrath, Chief Executive Officer, on September 11, 2026.

Opus Genetics Discloses Corrected Visual Acuity Data for OPGx-BEST1 Cohort 1

According to the filing, Opus Genetics (NASDAQ:IRD) furnished a revised clinical data presentation on September 11, 2026, superseding a version originally presented at an investor conference on September 9, 2026. The company disclosed that the revision was made to correct "an immaterial error in the translation of logMAR visual acuity into ETDRS letters," which affected the depiction of mean best-corrected visual acuity from baseline through three months for Cohort 1 on Slide 15 of the presentation.

The filing provides corrected three-month change-from-baseline figures for each of the five participants in Cohort 1. According to the filing: participant 101-101 had a 12 letter improvement in the treated eye and a 4 letter improvement in the fellow eye; participant 101-104 had a 1 letter improvement in the treated eye and a 7 letter loss in the fellow eye; participant 102-101 had a 10 letter loss in the treated eye and an 8 letter loss in the fellow eye; participant 102-102 had a 2 letter gain in the treated eye and a 5 letter loss in the fellow eye; and participant 101-106 had a 6 letter gain in the treated eye and a 2 letter gain in the fellow eye.

The company also disclosed that, in addition to the Slide 15 correction, high-resolution microperimetry grid images for baseline and three months were added to the appendix of the revised presentation for each participant, and that individual loci data is available for three of those participants. The revised presentation is furnished as Exhibit 99.1 to the filing.

What Was Disclosed

Opus Genetics filed a revised Regulation FD data presentation correcting a logMAR-to-ETDRS translation error on Slide 15 and adding microperimetry appendix images, providing updated per-participant visual acuity data for Cohort 1 of the OPGx-BEST1 Phase 1/2 trial.