Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Phentolamine Mesylate Ophthalmic Solution 1%, Phentolamine 1%, Phentolamine Mesylate Ophthalmic Solution 1.0%, Phentolamine 1.0%, 0.75% phentolamine ophthalmic solution, 0.75% phentolamine, 0.75% Phentolamine Ophthalmic Solution, 0.75% Phentolamine
Phentolamine Ophthalmic Solution · 6 trials · 10 indications
The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8)
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
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
Proportion of eyes with an increase ≥ 0.3 log (2 or more patches) in mesopic contrast sensitivity with glare at one or more frequencies at 1.5, 3, 6, 12, and 18 cycles per degree, measured with the HACSS methodology (categorical analysis)
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 |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | ACTIVE_COMPARATOR | Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist |
| phentolamine ophthalmic solution vehicle | PLACEBO_COMPARATOR | Drug: Placebo |
| Placebo - Phentolamine Ophthalmic Solution vehicle | PLACEBO_COMPARATOR | Placebo-phentolamine ophthalmic solution vehicle |
| 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 |
| Placebo | PLACEBO_COMPARATOR | Administered once daily in both eyes for 15 days |
| Phentolamine Mesylate Ophthalmic Solution 0.5% | EXPERIMENTAL | Administered once daily in both eyes for 15 days |
| Phentolamine Mesylate Ophthalmic Solution 1.0% | EXPERIMENTAL | Administered once daily in both eyes for 15 days |
| Name | Type | Description |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | DRUG | Once daily dosing |
| Placebo | DRUG | Once daily dosing |
| 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 |
| Phentolamine Mesylate Ophthalmic Solution 1.0% | DRUG | Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist |
| Phentolamine Mesylate Ophthalmic Solution 0.5% | DRUG | Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist |
Inclusion Criteria: Participants must meet all of the following criteria: 1. Males or females ≥ 45 and ≤ 64 years of age 2. Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits 3. Able and willing to give signed informed consent 4. Able to se...
Phentolamine 1% is an investigational small molecule being developed for open angle glaucoma, mydriasis, decrease in night vision, and night vision complaints. It is formulated as an ophthalmic solution and is currently in Phase 2 clinical development.
Phentolamine 1% is being developed by Opus Genetics, Inc., a company traded under the ticker IRD. The drug is in Phase 2 clinical trials for multiple ophthalmic indications.
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 use.
Phentolamine 1% has completed several Phase 2 trials, including NCT01703559 for night vision disturbances, NCT03960866 for open angle glaucoma, NCT04004507 for severe night vision disturbances, and NCT04024891 for reversing pharmacologically induced mydriasis. All trials were conducted in the United States.
Yes, Phentolamine 1% refers to phentolamine mesylate ophthalmic solution. Clinical trials listed under NCT01703559, NCT03960866, NCT04004507, and NCT04024891 evaluate phentolamine mesylate eye drops for various eye conditions.