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A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

Trial Profile

A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2024

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At a glance

  • Drugs Riboflavin (Primary)
  • Indications Keratoconus
  • Focus Registrational; Therapeutic Use
  • Sponsors Avedro; Glaukos Corporation

Most Recent Events

  • 25 Feb 2021 According to a Glaukos Corporation media release, this Phase 3 trial results are expected to support the U.S. NDA submission in 2022 and the company is targeting U.S. FDA approval for Epi-on in 2023.
  • 25 Feb 2021 Primary endpoint (Improvement in maximum corneal curvature (Kmax) at 6 months from baseline between the treated and placebo-controlled arms) has been met, according to a Glaukos Corporation media release.
  • 25 Feb 2021 Results presented in a Glaukos Corporation media release.

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