{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-023732","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2025-06-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.751102+00:00","generated_at":"2026-05-18T17:31:32.249248+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Opus Genetics VEGA-3 Phase 3 trial meets primary endpoint for presbyopia treatment","bullets":["27.2% of patients on drug achieved ≥15-letter DCNVA gain vs 11.5% placebo (p<0.0001) at 12h post-dose on Day 8.","Safety profile consistent with prior trials; no treatment-related serious adverse events reported.","No evidence of tachyphylaxis over the 6-week study period.","NDA submission to FDA planned for the second half of 2025.","Cash on hand expected to fund operations into H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-023732","json":"https://secwatch.observer/filing/0001140361-25-023732.json","markdown":"https://secwatch.observer/filing/0001140361-25-023732.md","text":"https://secwatch.observer/filing/0001140361-25-023732.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125023732/0001140361-25-023732-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125023732/ef20051231_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T17:31:32.249248+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"}