secwatch.observer — SEC 8-K summary
======================================

Issuer:     KALA BIO, Inc. (KALA)
CIK:        0001479419
Form:       8-K
Filed at:   2025-07-09T23:59:59+00:00
Accession:  0001104659-25-066593
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

KALA BIO completes enrollment in Phase 2b trial of KPI-012 for PCED; topline data expected Q3 2025
--------------------------------------------------------------------------------

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1479419/000110465925066593/0001104659-25-066593-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1479419/000110465925066593/tm2520099d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-066593

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer