{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-036637","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2025-09-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.527567+00:00","generated_at":"2026-05-17T05:13:36.220609+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Opus Genetics LCA5 gene therapy shows 0.3 logMAR improvement in pediatric cohort; durable 18-month adult data","bullets":["Three pediatric participants (ages 16-17) showed group avg 0.3 logMAR visual acuity improvement and >1 log unit cone sensitivity improvement on FST.","All three pediatric participants improved on mobility test; microperimetry showed improved fixation in one evaluable participant.","Adult data (3 participants) show visual acuity improvements sustained through 18 months; therapy well-tolerated with no ocular SAEs.","Company expects to meet with FDA in Q4 2025 to discuss results and next steps for OPGx-LCA5 program.","No ocular serious adverse events or dose-limiting toxicities; all ocular AEs mild, anticipated, not related to study drug."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-036637","json":"https://secwatch.observer/filing/0001140361-25-036637.json","markdown":"https://secwatch.observer/filing/0001140361-25-036637.md","text":"https://secwatch.observer/filing/0001140361-25-036637.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125036637/0001140361-25-036637-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125036637/ef20056246_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:13:36.220609+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"}