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Also known as 0.75% Phentolamine Ophthalmic Solution
0.75% Phentolamine · 2 trials · 3 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
| 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 |
| Name | Type | Description |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | DRUG | Once daily dosing |
| Placebo | DRUG | Once daily dosing |
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...
0.75% Phentolamine is an ophthalmic solution being developed for presbyopia and for decreased mesopic visual acuity, or night vision loss, in patients who have undergone keratorefractive surgery. It is a small molecule in Phase 3 clinical development for these ophthalmology indications.
0.75% Phentolamine is an alpha-adrenergic antagonist that works by blocking alpha receptors in the iris dilator muscle, which reduces pupil size. This mechanism is intended to improve near vision in presbyopia and to reduce night vision disturbances after refractive surgery.
0.75% Phentolamine is being developed by Opus Genetics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IRD. The company is conducting Phase 3 clinical trials for this ophthalmic solution.
0.75% Phentolamine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been conducted or are ongoing to evaluate its safety and efficacy for presbyopia and night vision loss.
0.75% Phentolamine has been studied in two Phase 3 trials. NCT06542497, a completed trial with 569 participants, evaluated its efficacy and safety for presbyopia. NCT07140783, an ongoing recruiting trial with 200 participants, is assessing its use in keratorefractive surgery patients with decreased mesopic visual acuity.
Yes, 0.75% Phentolamine is also known as 0.75% Phentolamine Ophthalmic Solution. Both names refer to the same investigational drug being developed by Opus Genetics for presbyopia and night vision loss.