{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-035979","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2026-09-09T11:30:47+00:00","discovered_at":"2026-09-09T11:35:00.638777+00:00","generated_at":"2026-09-09T11:35:17.154951+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Opus Genetics reports positive Cohort 1 data for OPGx-BEST1; FDA aligns on pivotal endpoint","bullets":["All 5 Cohort 1 participants showed clinically meaningful visual function improvement; BCVA improved in 3/5, microperimetry in 3/4 evaluable.","No serious adverse events or dose-limiting toxicities; structural improvements in 4/5, including vitelliform reduction in 2/3 BVMD.","FDA aligned on ≥3 dB microperimetry improvement in ≥5 loci with patient-reported outcome as potential pivotal endpoint.","Cohort 2 over-enrolled to 8 participants; dosing complete Q4 2026, topline data Q2 2027; cash runway into 2029.","New epidemiology estimates ~23,600 symptomatic BEST1 patients in US and ~45,400 globally."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-035979","json":"https://secwatch.observer/filing/0001140361-26-035979.json","markdown":"https://secwatch.observer/filing/0001140361-26-035979.md","text":"https://secwatch.observer/filing/0001140361-26-035979.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126035979/0001140361-26-035979-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126035979/ef20081753_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-09T11:35:17.154951+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}