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Phentolamine Ophthalmic Solution 0.75%
Phentolamine is an alpha-adrenergic antagonist that blocks norepinephrine signaling in the eye to reduce pupil dilation and improve visual function in patients with presbyopia.
Phentolamine is an alpha-adrenergic antagonist that blocks norepinephrine signaling in the eye to reduce pupil dilation and improve visual function in patients with presbyopia. Used for Presbyopia (age-related loss of accommodation).
At a glance
| Generic name | Phentolamine Ophthalmic Solution 0.75% |
|---|---|
| Also known as | Nyxol, Nyxol® |
| Sponsor | Ocuphire Pharma, Inc. |
| Drug class | Alpha-adrenergic antagonist |
| Target | Alpha-1 and alpha-2 adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Phentolamine ophthalmic solution works by antagonizing alpha-1 and alpha-2 adrenergic receptors in the iris sphincter muscle, which reduces mydriasis (pupil dilation) and increases depth of focus through a miotic (pupil-constricting) effect. This mechanism helps restore accommodation and improve near vision in presbyopic patients without the systemic effects of oral alpha-blockers.
Approved indications
- Presbyopia (age-related loss of accommodation)
Common side effects
- Conjunctival hyperemia
- Eye irritation
- Mydriasis rebound
- Ocular discomfort
Key clinical trials
- Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia (PHASE3)
- Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (PHASE3)
- Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances (PHASE3)
- Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances (PHASE3)
- Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia (PHASE2)
- OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity (PHASE3)
- Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children (NA)
- Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Phentolamine Ophthalmic Solution 0.75% CI brief — competitive landscape report
- Phentolamine Ophthalmic Solution 0.75% updates RSS · CI watch RSS
- Ocuphire Pharma, Inc. portfolio CI