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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: 05 Mar 2026

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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 Feb 2026 According to an Opus Genetics media release, the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026., supported by data from a pivotal Phase 3 clinical program, including two trials, VEGA-2 and VEGA-3.
  • 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.

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