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Phentolamine - Opus Genetics

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Drug Profile

Phentolamine - Opus Genetics

Alternative Names: 0.75% phentolamine ophthalmic solution - Ocularis Pharma; 1% phentolamine mesylate - Ocularis Pharma; MR-141; MR-142; Nyxol; Phentolamine mesylate ophthalmic solution - Ocularis Pharma; RYZUMVI

Latest Information Update: 03 Mar 2026

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At a glance

  • Originator Ocularis Pharma
  • Developer Opus Genetics
  • Class Antiglaucomas; Erectile dysfunction therapies; Eye disorder therapies; Imidazoles; Peripheral vasodilators; Small molecules
  • Mechanism of Action Alpha 1 adrenergic receptor antagonists; Alpha 2 adrenergic receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Mydriasis
  • Preregistration Presbyopia
  • Phase III Nyctalopia
  • Phase II Ocular hypertension; Open-angle glaucoma

Most Recent Events

  • 25 Feb 2026 FDA assigns PDUFA action date of 17/10/2026 for Phentolamine for Presbyopia
  • 25 Feb 2026 US FDA accepts sNDA for Phentolamine for Presbyopia for review
  • 19 Feb 2026 Ocuphire Pharma completes the phase III LYNX-2 trial in Nyctalopia (Ophthalmic, Drops) in USA (NCT06349759)

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