{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-051009","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2023-11-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.462691+00:00","generated_at":"2026-06-08T23:28:07.459430+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ocuphire successful End-of-Phase 2 meeting with FDA for oral APX3330 in diabetic retinopathy","bullets":["FDA agreed on Phase 3 primary endpoint: ≥3-step worsening on binocular DRSS; SPA to be submitted.","APX3330 could be first oral option for ~8M US NPDR patients; Phase 2 ZETA-1 showed slowing of DR progression.","Company plans Special Protocol Assessment to finalize trial design and timing with FDA.","Phase 2 ZETA-1 met primary endpoint: lower % of APX3330-treated patients had ≥3-step worsening vs placebo at 24 weeks.","APX3330 demonstrated favorable safety/tolerability; CEO calls it 'most advanced oral therapy in development for DR'."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-051009","json":"https://secwatch.observer/filing/0001140361-23-051009.json","markdown":"https://secwatch.observer/filing/0001140361-23-051009.md","text":"https://secwatch.observer/filing/0001140361-23-051009.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036123051009/0001140361-23-051009-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036123051009/ef20013910_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T23:28:07.459430+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"}