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This is a Multi-center, Double-masked, Randomized, Vehicle-controlled Study Testing PL9643, an Opthalmic Solution, to Determine if it is Safe and Efficacious for Dry Eye Patients

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Trial Profile

This is a Multi-center, Double-masked, Randomized, Vehicle-controlled Study Testing PL9643, an Opthalmic Solution, to Determine if it is Safe and Efficacious for Dry Eye Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs PL 9643 (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms MELODY-1
  • Sponsors Palatin Technologies

    • Most Recent Events

    • 28 Aug 2024 Status changed from active, no longer recruiting to completed, According to a Palatin Technologies Media Release.
    • 15 May 2024 According to a Palatin Technologies Media Release, Type C meeting with the FDA on key elements of the pivotal Phase 3 clinical program is expected in the third quarter of calendar year 2024. NDA submission targeted for second half of calendar year 2025
    • 08 Apr 2024 According to a Palatin Technologies Media Release, topline results of this study were presented at the American Society of Cataract and Refractive Surgery (ASCRS).

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