{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-000615","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2026-01-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.666809+00:00","generated_at":"2026-05-16T11:10:31.625548+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Opus Genetics details 2025 progress and 2026 catalysts; cash >$50M, sNDA for presbyopia submitted","bullets":["sNDA submitted for phentolamine 0.75% (presbyopia); FDA decision expected by end of 2026.","BEST1 Phase 1/2 initial data this quarter at Macula Society; Cohort 1 3-month results mid-2026.","LCA5 Phase 3 pivotal trial dosing expected in H2 2026 after run-in enrollment.","Cash and equivalents >$50M following $23M equity raise; runway into H2 2027.","One to two preclinical IRD programs (RHO, CNGB1, MERTK, RDH12-LCA, NMNAT1) targeting clinical entry in 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-000615","json":"https://secwatch.observer/filing/0001140361-26-000615.json","markdown":"https://secwatch.observer/filing/0001140361-26-000615.md","text":"https://secwatch.observer/filing/0001140361-26-000615.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/0001140361-26-000615-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036126000615/ef20062523_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:10:31.625548+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"}