Opus Genetics, Inc. 8-K filed 2026-09-11
- Accession
- 0001140361-26-036277
- Cik
- 1228627
- Company name
- Opus Genetics, Inc.
- Date filed
- 2026-09-11
- Form
- 8-K
- Index url
- https://www.sec.gov/Archives/edgar/data/1228627/000114036126036277/0001140361-26-036277-index.htm
- Txt url
- https://www.sec.gov/Archives/edgar/data/1228627/0001140361-26-036277.txt
Plain-English summary
Opus Genetics, Inc., listed on Nasdaq under the ticker IRD and formerly named Ocuphire Pharma, Inc., filed this Form 8-K on 2026-09-11 under Item 7.01, Regulation FD Disclosure. It furnishes, as Exhibit 99.1, a revised version of the data presentation the company first used at its investor conference on September 9, 2026. That presentation announced clinical data from Cohort 1 of the company's ongoing Phase 1/2 clinical trial of OPGx-BEST1 in patients with BEST1-related retinal diseases, and its title page reads "Low Dose Cohort 1 3-month Results." The original presentation was furnished on a separate Form 8-K on September 9, 2026.
The company says the revision corrects an immaterial error in the translation of logMAR visual acuity into ETDRS letters. The error affected how Slide 15 depicted mean best-corrected visual acuity from baseline through 3 months in Cohort 1. The filing gives the correct three month change from baseline for each participant. 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. Participant 101-106 had a 6 letter gain in the treated eye and a 2 letter gain in the fellow eye.
The revised deck also adds high-resolution images of the microperimetry grids at baseline and 3 months to the Appendix for each participant. The filing states that individual loci data is available for three participants in these images, although it lists visual acuity figures for five participants. The filing does not say which three participants have loci data. Readers comparing the two versions should note that the originally published figures and the corrected mean value on Slide 15 are not in the filing excerpt. The full revised presentation is available at the SEC source link.
The filing was signed by Dr. George Magrath, Chief Executive Officer. The company is classified as a non-accelerated filer and smaller reporting company. Safety data, microperimetry results, dose levels, the total enrollment of Cohort 1, and any financial information are not in the filing excerpt.
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