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
Phentolamine Ophthalmic Solution · 6 trials · 10 indications
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
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).
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 two 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 | EXPERIMENTAL | 0.75% Phentolamine Ophthalmic Solution |
| Placebo - Phentolamine Ophthalmic Solution vehicle | PLACEBO_COMPARATOR | Placebo-phentolamine ophthalmic solution vehicle |
| phentolamine ophthalmic solution vehicle | PLACEBO_COMPARATOR | Drug: Placebo |
| 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: 1. Males or females ≥ 18 years of age 2. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits 3. Able and willing to give written consent to participate in this study 4. Able to self-administer study medication Inclusio...
Phentolamine ophthalmic solution is an investigational small molecule eye drop developed by Opus Genetics, Inc. (ticker IRD). It is being studied in eye conditions including presbyopia, pharmacologically induced mydriasis, night vision complaints, decreased night vision, open angle glaucoma, and vision loss at night. It is not yet approved and remains in clinical development.
Phentolamine ophthalmic solution targets the alpha-adrenergic receptors ADRA1A, ADRA1B, ADRA1D, ADRA2A, ADRA2B, and ADRA2C as an antagonist. By blocking these receptors, the small molecule acts on alpha-adrenergic signaling in the eye. This receptor antagonist activity underlies its investigation across pupil dilation and visual function conditions.
Opus Genetics, Inc., which trades under the ticker IRD, is the developer of phentolamine ophthalmic solution. The company is advancing the small molecule eye drop across several ophthalmic indications, including presbyopia, mydriasis, and night vision disturbances, through clinical trials conducted in the United States.
Phentolamine ophthalmic solution is in Phase 2 development according to its overall program status, though individual studies have reached Phase 3. It is investigational and has not been approved by the FDA. Trials have evaluated it in presbyopia, mydriasis, and night vision disturbances, with a Phase 3 keratorefractive surgery study currently recruiting.
Phentolamine ophthalmic solution has been studied in NCT07140783, a recruiting Phase 3 trial in keratorefractive surgery participants with decreased mesopic visual acuity, and NCT06542497, a completed Phase 3 presbyopia trial. Earlier completed Phase 2 studies include NCT04024891 in pharmacologically induced mydriasis and NCT04004507 in severe night vision disturbances.
Yes, phentolamine ophthalmic solution is also known as phentolamine mesylate ophthalmic solution 1%, phentolamine 1%, phentolamine mesylate ophthalmic solution 1.0%, phentolamine 1.0%, and 0.75% phentolamine ophthalmic solution. These names refer to the same investigational product developed by Opus Genetics, Inc. (ticker IRD) for ophthalmic use.