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A Double-Masked, Active-Controlled Study of the Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

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Trial Profile

A Double-Masked, Active-Controlled Study of the Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2023

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At a glance

  • Drugs Phenylephrine/tropicamide (Primary) ; Phenylephrine; Tropicamide
  • Indications Mydriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms MIST-1
  • Sponsors Eyenovia

    • Most Recent Events

    • 01 Jun 2023 Accoding to an Eyenovia media release, Norbert Lowe, US FDA has approved Mydcombi, first and only FDA-approved tropicamide and phenylephrine ophthalmic spray for mydriasis.
    • 01 Jun 2023 Accoding to an Eyenovia media release, Norbert Lowe, Eyenovia's Vice President of Commercial Operations, will present highlights on recent FDA approval of Mydcombi at the annual OCTANE Ophthalmology Tech Forum 2023, which is scheduled for Friday, June 9th at 5:00 p.m. PDT in Newport Beach, CA.
    • 13 Dec 2022 Accoding to an Eyenovia media release, the company is currently not planning to hold an advisory committee meeting to discuss the application.

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