{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-004634","form_type":"8-K","ticker":"KALA","cik":"0001479419","company_name":"KALA BIO, Inc.","filed_at":"2023-03-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:45.180979+00:00","generated_at":"2026-06-17T14:44:40.541298+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Kala Pharma reports positive safety data in CHASE Phase 2b trial of KPI-012; second cohort initiated","bullets":["Both patients in open-label first cohort (high dose 3 U/mL QID) completed at least 1 week with no safety issues.","Second cohort is randomized, double-masked, vehicle-controlled study of ~90 patients testing two doses vs vehicle for 56 days.","Primary endpoint is complete healing of PCED measured by corneal fluorescein staining.","Topline safety and efficacy data expected in Q1 2024; positive results could support first pivotal trial for BLA."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-004634","json":"https://secwatch.observer/filing/0001558370-23-004634.json","markdown":"https://secwatch.observer/filing/0001558370-23-004634.md","text":"https://secwatch.observer/filing/0001558370-23-004634.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1479419/000155837023004634/0001558370-23-004634-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1479419/000155837023004634/kala-20230327x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T14:44:40.541298+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"}