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A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Trial Profile

A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 May 2025

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At a glance

  • Drugs KPI 012 (Primary)
  • Indications Corneal injuries
  • Focus Registrational; Therapeutic Use
  • Acronyms CHASE
  • Sponsors Combangio Inc; KALA BIO

Most Recent Events

  • 14 May 2025 According to a Kala Pharamceuticals media release, top-line results from this study expected in the third quarter of 2025. Contingent on positive results and subject to discussion with regulatory authorities, the Company believes the CHASE Phase 2b trial could potentially serve as the first of two pivotal studies required to support the submission of a Biologics License Application (BLA) to the FDA.
  • 23 Apr 2025 Planned End Date changed from 1 Oct 2025 to 1 Jun 2026.
  • 23 Apr 2025 Planned primary completion date changed from 1 Mar 2025 to 1 Sep 2025.

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