FDA approves Ryzumvi for treatment of pharmacologically induced mydriasis
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Key takeaways:
- The FDA approved Ryzumvi for the treatment of pharmacologically induced mydriasis.
- Ryzumvi is expected to be available in the U.S. in 2024.
The FDA approved Ryzumvi for the treatment of pharmacologically induced mydriasis produced by adrenergic agonists or parasympatholytic agents, according to a press release from Ocuphire Pharma and Viatris.
Ryzumvi (phentolamine ophthalmic solution 0.75%), formerly known as Nyxol, was evaluated in the MIRA clinical trial program, which included more than 600 participants. In the MIRA-2 and MIRA-3 phase 3 pivotal trials, 553 participants aged 12 to 80 years were given two drops in the study eye or one drop in the fellow eye of either Ryzumvi or placebo 1 hour after induced mydriasis.
In the two trials, the percentage of participants with study eyes that returned to 0.2 mm or less from baseline pupil diameter was statistically significantly greater at all time points measured from 60 minutes through 24 hours in the Ryzumvi group compared with the placebo group (P < .01), the release said.
Efficacy was similar in all age ranges, including participants aged 3 to 17 years. The phase 3 MIRA-4 pediatric trial comprised participants aged 3 to 11 years.
The most commonly reported ocular adverse events in the trials were pain, stinging and burning at the instillation site (16%) and conjunctival hyperemia (12%). Additionally, 6% of participants reported experiencing dysgeusia, the only non-ocular adverse event.
“Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases,” Jeffrey Nau, PhD, president of Viatris Eye Care Division, said in the release. “Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.”
The companies expect Ryzumvi to be available in the U.S. in the first half of 2024.
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