Viatris launches Ryzumvi for mydriasis reversal
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Key takeaways:
- Viatris is launching Ryzumvi for the reversal of dilation.
- The drug’s onset of action generally occurs in 30 minutes.
Viatris is launching the first commercially available, FDA-approved eyedrop for the reversal of dilation, according to a press release.
The FDA approved Ryzumvi (phentolamine ophthalmic solution 0.75%) in September 2023 following positive results of two randomized, vehicle-controlled trials.
In the MIRA-2 and MIRA-3 trials, 553 patients aged 12 to 80 years underwent mydriasisinduced by instillation of phenylephrine, tropicamide or Paremyd (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) followed by two drops of Ryzumvi in the study eye or one drop in the fellow eye of either Ryzumvi or a placebo on hour after instillation of the mydriatic agent.
At 90 minutes after administration, 49% and 58% of patients who received two drops of Ryzumvi returned to 0.2 mm or less of baseline pupil diameter compared with 7% and 6% of the patients who received placebo. Ryzumvi’s onset of action generally occurs in 30 minutes, according to the release.
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