Phentolamine Ophthalmic Solution Speeds Visual Recovery, With Ralph Chu, MD

New data from the Phase 3 MIRA-2 and MIRA-3 trials show that phentolamine ophthalmic solution 0.75% significantly improves patient-reported visual symptoms following pharmacologically induced mydriasis.

Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, participants receiving phentolamine ophthalmic solution reported a benefit in the resolution of visual symptoms, even before the full return to ≤0.2mm of pupil diameter.

“One of the things that I've understood over the years, and we all know, is that patients don't like getting their eyes dilated, and they often hold back on getting their eye exams because they don't want to be dilated,” Ralph Chu, MD, founder and medical director of Chu Vision Institute, told HCPLive. “Having this drop, this is the first time in over 15 years that eye care practitioners have had this ability to reverse dilation.”

The double-masked, placebo-controlled studies enrolled 553 subjects aged ≥12 years. After dilation with standard agents (2.5% phenylephrine, 1% tropicamide, or Paremyd), participants received either phentolamine ophthalmic solution or placebo. Patient-reported outcomes measured difficulty with reading, blurriness, distance vision, and overall satisfaction.

Upon analysis, the findings demonstrated a clear advantage for phentolamine ophthalmic solution, with 69.8% of patients returning to baseline reading ability within 60 minutes, compared with 44.8% for placebo (P =.002). Satisfaction with vision improved significantly as early as 60 minutes after treatment with phentolamine ophthalmic solution (51.5% vs. 30.5%, P =.01).

“As soon as an hour to an hour and a half after instillation of the drop, patients were noticing improved symptoms, which is huge,” Chu told HCPLive. “It was a four-hour decrease in the average time for reversal of symptoms, and that was important clinically for patient satisfaction.”

Beyond the clinic, phentolamine ophthalmic solution may influence broader eye care patterns. The study revealed that symptoms like glare and blurry vision can persist up to 24 hours post-dilation without reversal. With phentolamine ophthalmic solution, improvements were noted within 1–2 hours.

“In this clinical trial, we learned that after having this drop instilled, patients notice improved symptoms, and that's critical," Chu told HCPLive. "They may be more apt to come in for a refractive surgery evaluation or a dilated annual exam. This helps improve the patient experience, but also allows for more thorough, comprehensive eye care.”

Chu reports a disclosure with Zeiss.

Reference

1. Chu YR, Jackson MA, Charizanis K et al. Patient Reported Outcomes and Vision Benefits of Phentolamine Ophthalmic Solution 0.75% in Reversing Pharmacologically Induced Mydriasis. Paper presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.