Viatris launches RYZUMVl 0.75% in US

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours

  • By IPP Bureau | April 02, 2024

Viatris, a global healthcare company, announced the U.S. commercial launch of RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholyticagents in the United States.  RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation.

According to the American Academy of Ophthalmology and the American Optometric Association, clinical practice guidelines recommend dilation as a standard of care. Dilation allows eye care professionals to identify both common and serious eye health issues, including signs of systemic disease. The average time of dilation lasts three to eight hours, but can last up to 24 hours in some people. Prolonged dilation may lead to patients refusing dilation.

The U.S. Food and Drug Administration (FDA) approved RYZUMVI in September 2023.  The onset of action of RYZUMVI generally occurs in 30 minutes.  In the MIRA-2 and MIRA-3 clinical trials, at 90 minutes after administration, 49% and 58% of patients administered 2 drops of RYZUMVI returned to ≤ 0.2 mm of baseline pupil diameter compared to 7% and 6% of patients administered placebo, respectively.  In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours.  In the MIRA-3 trials' placebo group, 28% of patients were still dilated at 24 hours.

RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.

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