KALA BIO Completes Enrollment in CHASE Trial for KPI-012 in Persistent Corneal Epithelial Defect

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Release Date

2025-07-10

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

KALA BIO announced the completion of patient enrollment in the CHASE Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED). The multicenter, randomized, double-masked trial is assessing the safety and efficacy of KPI-012 compared to a vehicle control. Topline results are expected by the end of Q3 2025. If positive, the CHASE trial could potentially serve as a pivotal trial for a Biologics License Application (BLA) submission to the FDA. KPI-012 has received Orphan Drug and Fast Track designations from the FDA for PCED.

Key Highlights

  • Completion of patient enrollment in the CHASE Phase 2b clinical trial for KPI-012.
  • Topline data expected by the end of Q3 2025.
  • Potential for CHASE to serve as a pivotal trial for BLA submission.
  • KPI-012 has received Orphan Drug and Fast Track designations from the FDA.

Incidence and Prevalence

Global Incidence and Prevalence of Persistent Corneal Epithelial Defect

Based on a thorough review of available PubMed literature, there are currently no specific global incidence or prevalence estimates for Persistent Corneal Epithelial Defect (PCED). The current literature discusses aspects of PCED such as its causes, diagnosis, and treatment approaches, but does not provide comprehensive epidemiological data regarding its global occurrence.

Study Design Parameters

Study Design Parameters and Endpoints in Key Trials for Persistent Corneal Epithelial Defect

Study Design Methodologies

Several study designs were employed in PED research:

  • Retrospective studies were common, including:

  • Review of medical records of patients with PEDs treated with 50% autologous serum eyedrops (September 2004 to May 2007)

  • Retrospective evaluation of 34 eyes of 26 patients treated with single-dose autologous serum eye drops (March 2016 to May 2020)

  • Retrospective analysis of 20 eyes of 19 patients treated with PROSE device (March 2003 to August 2008)

  • Retrospective reviews of 195 consecutive medical records of vitrectomized patients

  • Observational case series including:

  • Study of 8 consecutive patients with monolateral neurotrophic keratitis compared to 20 age- and sex-matched healthy participants

  • Study of 21 patients (23 eyes) with PEDs resistant to conventional therapy treated with RGTA (Cacicol)

  • Prospective interventional case series (transplantation of tissue-cultured human CLECs in 37 PED eyes)

  • Uncontrolled prospective case series (6 patients with severe neurotrophic ulcers treated with RGTA)
  • Single-center retrospective review (consecutive patients with non-healing corneal ulcers treated with self-retained cAM)

Patient Populations

Studies included patients with: - PEDs resistant to conventional therapy with various etiologies:

  • Neurotrophic ulcers (most common in several studies)

  • Post-keratoplasty (most common indication in single-dose ASED study)

  • Herpetic origin (11 eyes in one study)

  • Other causes: chemical burns, Stevens-Johnson syndrome, lagophthalmos, severe dry eye, peripheral ulcerative keratitis, fungal keratitis, and bacterial keratitis

  • Post-vitrectomy patients
  • Diabetic patients (identified as a higher risk group)

Interventions

Various treatment modalities were studied: - Autologous serum eye drops (ASEDs):

  • 50% concentration administered every 2 hours while awake

  • 20% concentration prepared in single-dose vials

  • Single-dose vials stored at -20°C

  • RGTA (Cacicol) administered as one drop on alternate days

  • PROSE device with:

  • Overnight wear protocol

  • Addition of nonpreserved topical ophthalmic moxifloxacin

  • Cord lining epithelial cells (CLECs) transplantation

  • Self-retained cryopreserved amniotic membrane (cAM)
  • Scleral contact lenses

Assessment Methods

  • Slit-lamp examination
  • Anterior segment photography
  • Fluorescein-dye testing
  • Corneal staining (Oxford scale)
  • Corneal sensitivity testing (Cochet-Bonnet esthesiometry)
  • In vivo slit scanning confocal microscopy

Primary Endpoints

  • Complete corneal healing/re-epithelialization
  • Time to healing (days)
  • Decrease ratio of ulcer area
  • Success rate of treatment (complete, partial, or no response)
  • Corneal defect size changes

Secondary Endpoints

  • Ocular discomfort
  • Corneal staining
  • Corneal signs
  • Visual acuity
  • Complications and adverse events
  • Ulcer recurrence
  • Impression cytology detection of normal corneal epithelial cells
  • Histopathological examination of transplant sites

Follow-up Protocols

Follow-up periods varied across studies: - Minimum 3-month follow-up in vitrectomy study - Assessment at 1 week, 1 month, 3 months, and 6 months in the cAM study - Mean follow-up of 9.2 ± 7.4 months in the scleral lens study

Results Highlights

  • RGTA study: 86.9% of eyes showed complete healing after mean period of ~7.2 days
  • 50% ASED study: 23 of 25 eyes healed in mean time of 22.4 days; 68% healed within 4 weeks
  • Single-dose ASED study: 73.5% eyes showed complete effectiveness, 14.7% partial effectiveness
  • PROSE device study: Re-epithelialization occurred in 17 of 20 eyes, with median treatment duration of 8.5 days

Safety Outcomes

  • No treatment-related side effects reported with RGTA
  • No cases of microbial keratitis with PROSE device when used with moxifloxacin
  • No complications related to single-dose ASED treatment

KPI-012 Clinical Trials Information

Based on the available information, there is no data regarding KPI-012 clinical trials for persistent corneal epithelial defect or any other indications. The information about intervention models for these trials is also not available in the provided context.

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