The FDA approval was supported by the data from the MIRA trial programme in which the percentage of subjects with study eyes returning to 0.2 mm from baseline pupil diameter was statistically significantly higher in the Ryzumvi group
Viatris global headquarters in US. (Credit: Viatris Inc.)
US-based Viatris and Ocuphire Pharma have received US Food and Drug Administration (FDA) approval for Ryzumvi (phentolamine ophthalmic solution) 0.75% eye drops to treat pharmacologically induced mydriasis produced by adrenergic agonists or parasympatholytic agents.
Ryzumvi is an anti-microbial preservative-free, topical eye drop formulation. The FDA-cleared eye drop is a relatively non-selective alpha-1 and alpha-2 adrenergic agonist.
Ocuphire interim CEO Rick Rodgers said: “We are pleased to receive FDA approval of Ryzumvi eye drops and look forward to Viatris’ successful commercial execution.
“We are grateful to the many patients and investigators who participated in our clinical trials, as well as the Ocuphire and Viatris teams for their commitment to patients.”
The FDA approval was supported by the data from the MIRA trial programme that involved over 600 subjects. It included the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 trials, and MIRA-4 Phase 3 paediatric trial.
In the MIRA-2 and MIRA-3 studies, a total of 553 individuals aged 12 to 80 years were randomised with two drops or one drop of Ryzumvi or placebo one hour after the instillation of the mydriatic agent.
The percentage of subjects with study eyes returning to 0.2 mm from baseline pupil diameter was statistically significantly higher in the Ryzumvi group at all-time points measured from 60 minutes through 24 hours.
The solution’s effectiveness was comparable across all age groups, including paediatric individuals aged three to three to 17 years, the American pharmaceutical firm said.
Viatris eye care division president Jeffrey Nau said: “The FDA’s approval of Ryzumvl marks a significant milestone for our Eye Care Division and underscores Viatris’ commitment to advancing eye care and enhancing access for both eye care professionals and patients.
“Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases. 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 ophthalmic solution is anticipated to be commercially available in the US in the first half of next year.