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Viatris, Ocuphire Pharma get USFDA nod for Ryzumvi for treatment of Pharmacologically-Induced Mydriasis

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-10-02T11:30:40+05:30  |  Updated On 2 Oct 2023 11:31 AM IST
Viatris, Ocuphire Pharma get USFDA nod for Ryzumvi for treatment of Pharmacologically-Induced Mydriasis
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Pittsburgh: Viatris Inc., a global healthcare company, and Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, have announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.

"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," said Viatris Eye Care Division President Jeffrey Nau, Ph.D. "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. We look forward to launching RYZUMVI in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders."

In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils, which can last up 24 hours. Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive.

"We are pleased to receive FDA approval of RYZUMVI eye drops and look forward to Viatris' successful commercial execution," said Rick Rodgers, MBA, Interim Chief Executive Officer of Ocuphire. "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."

RYZUMVI was evaluated in the comprehensive MIRA clinical trial program involving more than 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial. In the MIRA-2 and MIRA-3 trials, a total of 553 subjects aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd) were randomized. Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent. The percentage of subjects with study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater (p<0.01) at all time points measured from 60 minutes through 24 hours in the RYZUMVI group compared with the placebo (vehicle) group across both of the MIRA-2 and MIRA-3 trials. The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years. Pediatric subjects aged 12 to 17 years (n=27) were treated in MIRA-2 and MIRA-3 and pediatric subjects, aged 3 to 11 years (n=11) were treated in MIRA-4.

Read also: Biocon Biologics completes integration of acquired biosimilars business from Viatris in North America

viatrisviatris newsocuphire pharmaUSFDAryzumviphentolamine ophthalmic solutionmydriasis
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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