FDA approves Ryzumvi (phentolamine ophthalmic solution) for pharmacologically-induced mydriasis

The U.S. Food and Drug Administration has approved Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents, according to a company press release.

Ryzumvi is expected to be commercially available in the U.S. in the first half of 2024.

Ryzumvi was evaluated in the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial. In MIRA-2 and MIRA-3, 553 subjects aged 12 to 80 with induced mydriasis were randomly assigned to receive either Ryzumvi or a placebo after instillation of the mydriatic agent. The study found that a higher percentage of subjects who received Ryzumvi had their pupils return to ≤0.2 mm from baseline compared to those who received the placebo.

The most reported ocular adverse reactions in more than 5% of subjects included discomfort at the instillation site reported by 16% of subjects, and conjunctival hyperemia reported by 12% of subjects. The only non-ocular adverse reaction reported in more than 5% of subjects was dysgeusia, which was reported by 6% of subjects.

Read the full press release here.