The expanded U.S. indication adds presbyopia to RYZUMVI’s existing approval for pharmacologically induced pupil dilation, while Viatris explores a U.S. commercialization partner.
Viatris Inc. (NASDAQ: VTRS), a global healthcare company, has announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI® (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults.
The approval expands RYZUMVI’s existing U.S. indications, which include the treatment of pharmacologically induced mydriasis, or pupil dilation, caused by certain medications. According to Viatris, RYZUMVI is the only commercially available FDA-approved product for treating pharmacologically induced mydriasis in the United States.
Viatris is exploring the potential to partner with another company to commercialize RYZUMVI for presbyopia in the U.S. market.
RYZUMVI Expands into Presbyopia Treatment
Presbyopia is an age-related condition characterized by the gradual loss of the eye’s ability to focus on nearby objects. It typically becomes noticeable in the early to mid-40s and can cause blurred near vision and eye strain, affecting everyday activities and productivity.
The FDA approval provides RYZUMVI with an additional indication for adults experiencing presbyopia, expanding the product’s potential use in ophthalmology.
RYZUMVI: Approved Indications
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Presbyopia: Treatment in adults.
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Pharmacologically induced mydriasis: Treatment in adults and pediatric patients aged three years and older when pupil dilation is caused by adrenergic agonists, such as phenylephrine, or parasympatholytic agents, such as tropicamide.
Viatris and Opus Genetics Collaboration
Viatris and Opus Genetics are parties to a global licensing agreement covering the development of phentolamine ophthalmic solution 0.75%.
Under the agreement, Viatris holds exclusive rights to commercialize the product in the United States. The company is now exploring a potential U.S. commercialization partnership specifically for the presbyopia indication.
Important Safety Information
Warnings and Precautions
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Uveitis: RYZUMVI is not recommended for patients with active ocular inflammation, such as iritis.
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Potential eye injury or contamination: Patients should avoid allowing the vial tip to touch the eye or any other surface.
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Contact lens use: Contact lenses should be removed before administering RYZUMVI and may be reinserted 10 minutes after dosing.
Adverse Reactions
The most common ocular adverse reactions reported in more than 5% of subjects in presbyopia studies were:
| Adverse reaction | Reported incidence |
|---|---|
| Conjunctival hyperemia (eye redness) | 21% |
| Instillation-site irritation | 16% |
For pharmacologically induced mydriasis, the most common ocular adverse reactions were instillation-site discomfort, including pain, stinging and burning, reported in 16% of subjects, and conjunctival hyperemia, reported in 12%. Dysgeusia, or altered taste, was the only non-ocular adverse reaction reported in more than 5% of subjects, at 6%.
The company reported that most adverse reactions were mild, transient and self-resolving. Healthcare professionals and patients should consult the complete prescribing information for further safety details.
About Viatris
Viatris Inc. is a global healthcare company focused on helping people live healthier lives at every stage. Headquartered in the United States, the company has global centers in Pittsburgh, Shanghai and Hyderabad, India.
Its portfolio spans generic medicines, value-added medicines, established brands and innovative medicines addressing areas of significant unmet medical need.
Website: https://www.viatris.com
Investor Relations: https://investor.viatris.com
Outlook
The FDA’s approval of RYZUMVI for presbyopia expands the product’s approved uses in the United States and creates a potential new commercial opportunity for Viatris. The company is exploring a U.S. commercialization partner for the new indication, while RYZUMVI retains its existing approval for pharmacologically induced mydriasis.
