{"filing":{"accession_number":"0001140361-26-036277","cik":"0001228627","ticker":"IRD","company_name":"Opus Genetics, Inc.","form":"8-K","filing_date":"2026-09-11","report_date":"2026-09-11","primary_document":"ef20081922_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126036277/ef20081922_8k.htm"},"events":[{"id":32815,"run_id":30167,"accession_number":"0001140361-26-036277","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"This Item 7.01 disclosure announces clinical trial data from Opus Genetics' Phase 1/2 study of OPGx-BEST1, a gene therapy candidate for BEST1-related retinal diseases. The filing corrects an immaterial translation error in visual acuity metrics from the original September 9, 2026 presentation and provides detailed efficacy and safety results (75% of participants met FDA-aligned microperimetry endpoints, no serious adverse events, well-tolerated profile). While framed as a Regulation FD disclosure, the substance is a material clinical milestone—positive Phase 1/2 data supporting advancement to Cohort 2 and pivotal trial planning—that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory pathway.","company_name":"Opus Genetics, Inc.","ticker":"IRD","filing_date":"2026-09-11","form":"8-K","submitted_at":null,"items":[{"id":36081,"accession_number":"0001140361-26-036277","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"This Item 7.01 disclosure announces clinical trial data from Opus Genetics' Phase 1/2 study of OPGx-BEST1, a gene therapy candidate for BEST1-related retinal diseases. The filing corrects an immaterial translation error in visual acuity metrics from the original September 9, 2026 presentation and provides detailed efficacy and safety results (75% of participants met FDA-aligned microperimetry endpoints, no serious adverse events, well-tolerated profile). While framed as a Regulation FD disclosure, the substance is a material clinical milestone—positive Phase 1/2 data supporting advancement to Cohort 2 and pivotal trial planning—that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-11T11:49:56.997959+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":36081,"accession_number":"0001140361-26-036277","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"This Item 7.01 disclosure announces clinical trial data from Opus Genetics' Phase 1/2 study of OPGx-BEST1, a gene therapy candidate for BEST1-related retinal diseases. The filing corrects an immaterial translation error in visual acuity metrics from the original September 9, 2026 presentation and provides detailed efficacy and safety results (75% of participants met FDA-aligned microperimetry endpoints, no serious adverse events, well-tolerated profile). While framed as a Regulation FD disclosure, the substance is a material clinical milestone—positive Phase 1/2 data supporting advancement to Cohort 2 and pivotal trial planning—that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-11T11:49:56.997959+00:00","company_name":"Opus Genetics, Inc.","ticker":"IRD","filing_date":"2026-09-11"}]}