Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd) * To evaluate the safety of Nyxol * To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis

Timeline

Start

2020-11-18

Primary completion

2020-12-23

Completion

2021-03-15

Outcome

Met primary endpoint

release “These topline results indicate that the MIRA-2 trial met its primary endpoint” opusgtx.com ↗

release “recently completed pivotal MIRA-2 trial for Nyxol for the reversal of pharmacologically induced mydriasis, which met its primary endpoint” opusgtx.com ↗

release “The MIRA-2 and MIRA-3 trials successfully met their primary and key secondary endpoints” opusgtx.com ↗

Publications

• Pepose JS, Foster S, Pearson C, Brigell M, Charizanis K. Reversal of Pharmacologic Mydriasis in Pediatric Subjects with Ryzumvi (0.75% Phentolamine Ophthalmic Solution): A Post-Hoc Pooled Analysis from Three Randomized, Placebo-Controlled Phase 3 Trials. Clin Ophthalmol. 2026 Feb 20;20:563499. doi: 10.2147/OPTH.S563499. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentolamine	Small molecule	0.75 %	Topical

Indications

No indication recorded.