{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-039781","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2026-10-15T21:23:06+00:00","discovered_at":"2026-10-15T21:24:00.274540+00:00","generated_at":"2026-10-15T21:24:05.369335+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Opus Genetics: OPGx-BEST1 helps 75% of evaluable patients; OPGx-LCA5 Phase 3 dosing set for Q4 2026","bullets":["OPGx-BEST1 low-dose Cohort 1 (1.5E9 vg/eye): 3 of 4 evaluable patients (75%) improved retinal sensitivity in the treated transitional zone, 3-6 months follow-up.","High-dose Cohort 2 (4.5E9 vg/eye) fully enrolled with 11 participants; FDA aligned on a >=3 dB gain at >=5 loci in treated transitional zone as endpoint.","OPGx-LCA5 Phase 1/2 at 1E10 vg/eye: 3 adults sustained visual acuity and light sensitivity gains through 24 months; 3 pediatric patients improved through 6 months.","OPGx-LCA5 Phase 3 natural-history and treatment cohorts fully enrolled; dosing expected Q4 2026, primary endpoint retinal sensitivity across 16 central test locations.","OCT EZ-to-RPE thickness rose ~11.1 um in treated eyes vs 1.5 um in untreated fellow eyes by Day 90 in 3 participants; BEST1 US prevalence ~23,600."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-039781","json":"https://secwatch.observer/filing/0001140361-26-039781.json","markdown":"https://secwatch.observer/filing/0001140361-26-039781.md","text":"https://secwatch.observer/filing/0001140361-26-039781.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/0001140361-26-039781-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126039781/ef20083857_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-15T21:24:05.369335+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"}