KPI-012 / Kala Pharma - LARVOL DELTA

CHASE: Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED (clinicaltrials.gov) - P2 | N=103 | Terminated | Sponsor: Combangio, Inc | Trial completion date: Jun 2026 ➔ Oct 2025 | Active, not recruiting ➔ Terminated; Lack of efficacy

Trial completion date • Trial termination • Ocular Inflammation • Ophthalmology

CHASE: Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Combangio, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Ocular Inflammation • Ophthalmology

Safety and Efficacy of a Mesenchymal Stem Cell Secretome Therapy (KPI-012) for Persistent Corneal Epithelial Defects: A Phase 1b Trial. (PubMed, Curr Ther Res Clin Exp) - "The results from this small phase 1b open-label trial suggest that in participants with PCED of multiple etiologic origin, twice daily KPI-012 therapy exhibits a favorable safety profile-efficacy profile and may promote rapid wound healing. The small sample size limits the generalizability of the findings, and thus a later-phase clinical investigation with a larger sample size is warranted to establish the statistically driven therapeutic effect."

Journal • P1 data • Keratitis • Ocular Inflammation • Ophthalmology • Pain

CHASE: Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Combangio, Inc | Trial completion date: Oct 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Ocular Inflammation • Ophthalmology

CHASE: Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Combangio, Inc | Trial completion date: Aug 2024 ➔ Oct 2025 | Trial primary completion date: Feb 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Ocular Inflammation • Ophthalmology