Ryzumvi Now Available to Reverse Pharmacologically-Induced Mydriasis

Ryzumvi^™ (phentolamine ophthalmic solution, 0.75%) is now available for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents.

Ryzumvi is a preservative-free eye drop formulation of phentolamine mesylate, a nonselective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size. The approval was supported by data from the MIRA clinical program, which included the phase 3 MIRA-2 (ClinicalTrials.gov Identifier: NCT04620213) and MIRA-3 (ClinicalTrials.gov Identifier: NCT05134974) trials.

In both trials, the percentage of patients with study eyes returning to less than or equal to 0.2mm from baseline pupil diameter (primary endpoint) was statistically significantly greater (P <.01) at all time points measured from 60 minutes through 24 hours in the Ryzumvi group vs the placebo group. Results were found to be consistent regardless of the mydriatic agent used. 

The most common adverse reactions reported were instillation site discomfort, conjunctival hyperemia, and dysgeusia. Ryzumvi is not recommended to be used in patients with active ocular inflammation.

Ryzumvi is supplied in cartons containing 6 foil pouches; each pouch contains 5 single-patient-use vials. One vial should be dispensed for each patient and can be used to dose each dilated eye. The onset of action after administration generally occurs in 30 minutes, with the maximal effect seen in 60 to 90 minutes, and the effect lasting at least 24 hours.