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A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia

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Trial Profile

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Aug 2023

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At a glance

  • Drugs Pilocarpine (Primary)
  • Indications Presbyopia
  • Focus Registrational; Therapeutic Use
  • Acronyms VIRGO
  • Sponsors Allergan

    • Most Recent Events

    • 18 Aug 2023 Results assessing the safety, efficacy, and pharmacokinetics of pilocarpine hydrochloride 1.25% (Pilo hereafter) compared with vehicle when administered bilaterally, twice daily (6 hours apart) for 14 days in participants with presbyopia published in the American Journal of Ophthalmology
    • 05 Apr 2022 According to an Allergan media release, Christopher Lievens, O.D is the investigator for this trial.
    • 05 Apr 2022 According to an Allergan media release, the company to submit supplemental New Drug Application submission for twice-daily administration of VUITY™ (pilocarpine HCI ophthalmic solution) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022, based on data from this trial.
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