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Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects

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Trial Profile

Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2023

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At a glance

  • Drugs Phentolamine (Primary)
  • Indications Mydriasis
  • Focus Pharmacodynamics; Registrational
  • Acronyms MIRA-1
  • Sponsors Ocuphire Pharma

    • Most Recent Events

    • 27 Sep 2023 According to an Ocuphire Pharma media release, the U.S. Food and Drug Administration (FDA) has approved RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents
    • 13 Feb 2023 According to an Ocuphire Pharma media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.
    • 06 Dec 2022 According to an Ocuphire Pharma media release, the NDA is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial.

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