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A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

Trial Profile

A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2024

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At a glance

  • Drugs Atropine (Primary)
  • Indications Myopia
  • Focus Registrational; Therapeutic Use
  • Acronyms CHAMP
  • Sponsors Nevakar; Vyluma
  • Most Recent Events

    • 18 Jun 2024 According to a Vyluma media release, the Company had a Type A meeting with representatives of the U.S. Food and Drug Administration's (FDA's) Division of Ophthalmology to discuss the response to FDA's questions. The company will move forward with a submission to address FDA's questions in the third quarter of 2024.
    • 29 May 2024 According to a Vyluma media release, based on data from this trial the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002. The application is confirmed to be eligible for a Paediatric Use Marketing Authorisation (PUMA), providing 10 years of data exclusivity and marketing protection upon product approval.
    • 11 Oct 2023 Status changed from active, no longer recruiting to completed, according to a Vyluma media release.
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