{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-066593","form_type":"8-K","ticker":"KALA","cik":"0001479419","company_name":"KALA BIO, Inc.","filed_at":"2025-07-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.078185+00:00","generated_at":"2026-05-18T08:52:06.668889+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"KALA BIO completes enrollment in Phase 2b trial of KPI-012 for PCED; topline data expected Q3 2025","bullets":["CHASE trial randomized 79 patients across 37 sites in US and Latin America.","Two doses of KPI-012 (3 U/mL and 1 U/mL) vs vehicle, dosed QID for 56 days.","Primary endpoint: complete healing of PCED by corneal fluorescein staining photos (masked central reading).","Company expects to report topline data in Q3 2025; trial may serve as pivotal for BLA submission.","If positive, CHASE could potentially support BLA to FDA after regulatory discussion."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-066593","json":"https://secwatch.observer/filing/0001104659-25-066593.json","markdown":"https://secwatch.observer/filing/0001104659-25-066593.md","text":"https://secwatch.observer/filing/0001104659-25-066593.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1479419/000110465925066593/0001104659-25-066593-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1479419/000110465925066593/tm2520099d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T08:52:06.668889+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"}