Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phentolamine 1% · 3 trials · 6 indications
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
change from Baseline in mean diurnal IOP in the study eye
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.
| Arm | Type | Description |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | EXPERIMENTAL | 1 drop in each eye, 1 hour post medically-induced mydriasis |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | PLACEBO_COMPARATOR | 1 drop in each eye, 1 hour post medically-induced mydriasis |
| Nyxol Ophthalmic Solution 1% | EXPERIMENTAL | 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days |
| Nyxol Ophthalmic Solution Vehicle | PLACEBO_COMPARATOR | 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days |
| Name | Type | Description |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | DRUG | 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist |
| Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) | OTHER | Topical Sterile Ophthalmic Solution |
Inclusion Criteria: 1. Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only 2. Otherwise healthy and well controlled subjects 3. Able to comply with all protocol mandated procedures and to attend all scheduled office visits 4. Willing to give written informed consent to parti...
Phentolamine 1% is an investigational small molecule ophthalmic solution being studied for mydriasis, open angle glaucoma, decrease in night vision, and night vision complaints. It is in Phase 2 clinical development and has not been approved by the FDA.
Phentolamine 1% is an alpha-adrenergic antagonist that works by blocking alpha receptors in the eye. This mechanism is being studied to reverse pharmacologically induced mydriasis and to treat conditions such as open angle glaucoma and night vision disturbances.
Phentolamine 1% is being developed by Opus Genetics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this ophthalmic solution for multiple eye conditions.
Phentolamine 1% is in Phase 2 clinical development. It has received Fast Track designation from the FDA. The drug is investigational and has not been approved for any indication.
Phentolamine 1% has completed four Phase 2 trials. These include NCT01703559 and NCT04004507 for night vision disturbances, NCT03960866 for open angle glaucoma, and NCT04024891 for reversing pharmacologically induced mydriasis. All trials were conducted in the United States.
Phentolamine 1% refers to the concentration of the active ingredient phentolamine mesylate in an ophthalmic solution. Clinical trials for this drug use phentolamine mesylate ophthalmic solution, indicating they are the same compound at a 1% concentration.