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A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus

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Trial Profile

A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2025

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At a glance

  • Drugs Riboflavin (Primary)
  • Indications Keratoconus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Avedro

    • Most Recent Events

    • 24 Feb 2025 According to a Glaukos Corporation media release, company announced it has received the Day 74 notication from the U.S. Food and Drug Administration acknowledging the previously submitted New Drug Application for Epioxa is sufficiently complete to permit a substantive review.The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review of the Epioxa NDA is set for October 20, 2025.
    • 23 Dec 2024 According to an Avedro media release, based on data from two Phase 3 pivotal trials of Epioxa, company announced submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Epioxa (Epi-on), for the treatment of keratoconus.
    • 23 Jan 2017 Status changed from active, no longer recruiting to completed.

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