Viatris (VTRS) Gets FDA Nod for Pupil Dilation Reversal Agent
Viatris Inc. VTRS and partner Ocuphire Pharma, Inc. OCUP together announced the FDA approval of Ryzumvi (phentolamine ophthalmic solution) 0.75% to treat pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.
VTRS and OCUP anticipate the launch of Ryzumvi, an anti-microbial, topical eye drop formulation, in the U.S. market in the first half of 2024.
Per Viatris, approximately 100 million comprehensive eye exams take place in the United States each year, involving pharmacologically-induced mydriasis (or dilation) of the pupils, which can last up to 24 hours.
Although perceived harmless, dilation of pupils can cause certain side effects that may hamper the day-to-day activities of patients. For instance, pharmacologically-induced mydriasis causes sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive. This represents an unmet medical need.
Year to date, shares of Viatris have lost 13.9% compared with the industry’s 13% fall.
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The FDA approval of Ryzumvi was based on results from the comprehensive MIRA clinical study program,including the MIRA-1 phase IIb study, MIRA-2 and MIRA-3 phase III pivotal studies and MIRA-4 phase III pediatric patients (aged three to 11 years) study. The clinical program involved testing the drug on more than 600 patients.
Per VTRS, the MIRA-2 and MIRA-3 phase III pivotal studies enrolled a total of 553 subjects (aged 12-80 years), who had mydriasisinduced by the instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd).
In both pivotal studies, a statistically significantly greater percentage of subjects experienced their study eyes returning to normal at all time points measured from 60 minutes through 24 hours in the Ryzumvi group compared with placebo.
Viatris acquired licensing rights to Ryzumvi (formerly Nyxol) after acquiring FamyGenLife Sciences, Inc. in January 2023. FamyGenLife signed a license and collaboration agreement with Ocuphire Pharma in November 2022, which granted FamyGenLife Sciences (and hence Viatris, post-acquisition) an exclusive worldwide license to develop, manufacture, import, export and commercialize Ryzumvi as a mydriasis reversal agent, barring some countries and jurisdictions in Asia.
In the United States, VTRS will develop Ryzumvi in partnership with Ocuphire. Per the terms of the agreement, Viatris is also liable to pay a $10 million milestone payment to Ocuphire due to the FDA approval of Ryzumvi as a mydriasis reversal agent. This is expected to provide Ocuphire with an influx of cash.
Viatris Inc. Price and Consensus
Viatris Inc. price-consensus-chart | Viatris Inc. Quote
Zacks Rank and Stocks to Consider
Viatris currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the same industry are Dynavax Technologies DVAX and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 36.2%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.4%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Viatris Inc. (VTRS) : Free Stock Analysis Report
