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Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia

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Trial Profile

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Phentolamine (Primary) ; Pilocarpine (Primary)
  • Indications Presbyopia
  • Focus Registrational; Therapeutic Use
  • Acronyms VEGA 2
  • Sponsors Ocuphire Pharma

Most Recent Events

  • 26 Jun 2025 According to an Opus Genetics media release, the positive results from both VEGA-2 and VEGA-3 trials support the submission of an application to the USFDA, which the company plans to file in 2H 2025.
  • 21 Nov 2023 Status changed from active, no longer recruiting to completed.
  • 13 Nov 2023 Primary endpoint (Percent of subjects with 15 letters of improvement in photopic binocular DCNVA and with 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects) has been met as per Ocuphire Pharma media release

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