Phentolamine ophthalmic solution 0.75% is marketed as Ryzumvi for reversal of pharmacologically induced mydriasis after eye examinations or procedures. It is an alpha-adrenergic blocker administered into each dilated eye. The FDA first approved it on September 25, 2023.
Opus Genetics reported positive early data from its BEST1 gene therapy program and expects FDA action on its presbyopia treatment in October 2026. Ultragenyx announced 2025 revenue of $673 million and initiated a strategic restructuring plan targeting profitability in 2027.
The FDA accepted Viatris' application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a decision expected October 2026. Separately, the agency approved Yuvezzi, a once-daily combination eye drop for age-related near vision loss.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05223478 |
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects |
COMPLETED | PHASE3 |
| NCT05134974 |
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) |
COMPLETED | PHASE3 |
| NCT04675151 |
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia |
COMPLETED | PHASE2 |
| NCT04638660 |
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances |
COMPLETED | PHASE3 |
| NCT04620213 |
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis |
COMPLETED | PHASE3 |
