Viatris Receives U.S. FDA Approval for RYZUMVI® for the Treatment of Presbyopia

In presbyopia subjects, the most common ocular adverse reactions were conjunctival hyperemia (21%) and instillation site irritation (16%).

Rhea-AI Summary

Viatris (Nasdaq: VTRS) received U.S. FDA approval for RYZUMVI to treat presbyopia, the age-related loss of near focusing ability, in adults.

The approval expands the indications for phentolamine ophthalmic solution 0.75%, which is already approved in the United States to treat pharmacologically induced mydriasis, or drug-induced pupil dilation. Viatris is exploring a potential U.S. partner to commercialize RYZUMVI for presbyopia. A global licensing agreement with Opus Genetics provides for development of the solution and grants Viatris exclusive U.S. commercialization rights.

The product's warnings advise against use in patients with active eye inflammation and caution against touching the vial tip to the eye or other surfaces to avoid injury or contamination.

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0 major · 1 point

How the balance works

Positive

• Moderate pointFDA approval expands RYZUMVI's indications to include treatment of presbyopia in adults.
• Moderate pointPotential U.S. commercialization partner is being explored by Viatris for the presbyopia indication.
• Minor pointExclusive U.S. commercialization rights are held by Viatris under its licensing agreement with Opus Genetics.

Negative

• Minor pointSafety warnings advise against use with active eye inflammation and caution about eye injury or contamination.

Key Figures

Conjunctival hyperemia: 21% Instillation site irritation: 16%

Conjunctival hyperemia

21%

Most common ocular adverse reaction reported for presbyopia

Instillation site irritation

16%

Most common ocular adverse reactions reported for presbyopia

Key Terms

mydriasis, adrenergic agonists, parasympatholytic agents, uveitis, +1 more

5 terms

mydriasis medical

"RYZUMVI is currently approved in the United States for the treatment of pharmacologically-induced mydriasis"

Mydriasis is the widening or dilation of the pupil, the dark center of the eye, that lets in more light—similar to a camera aperture opening wider. It can occur naturally in low light, because of certain medications, or as a side effect of treatments and is important to investors because it is a measurable clinical sign used in drug trials, ophthalmic product evaluations, and safety assessments that can affect regulatory reviews and market potential.

adrenergic agonists medical

"pharmacologically-induced mydriasis produced by adrenergic agonists"

Adrenergic agonists are drugs that mimic adrenaline and similar natural chemicals to activate the body’s “fight-or-flight” system, affecting heart rate, blood vessel tone and airway opening. Investors care because these medicines can treat urgent conditions like heart failure, asthma or low blood pressure, so trial results, regulatory decisions or safety issues can quickly change a drug maker’s sales outlook and stock value — think of them as products that turn up the body’s emergency response.

parasympatholytic agents medical

"or parasympatholytic agents (e.g., tropicamide)"

Drugs that reduce or block the actions of the parasympathetic nervous system, most commonly by inhibiting acetylcholine at muscarinic receptors; they are often called antimuscarinic or anticholinergic agents. By preventing parasympathetic signals, they tend to decrease glandular secretions, dilate pupils, raise heart rate, and relax certain smooth muscles; the term covers different molecules and delivery methods but specifically denotes agents that produce those parasympathetic-blocking effects.

uveitis medical

"Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation"

Uveitis is inflammation inside the eye that can damage tissues responsible for clear vision, causing pain, light sensitivity, blurred sight, or permanent vision loss if untreated. For investors, it matters because it represents a medical condition with significant unmet need and chronic treatment requirements, influencing the size of potential drug or device markets, clinical trial design and endpoints, regulatory hurdles, and long-term revenue prospects — similar to how chronic engine trouble signals ongoing repair and maintenance demand.

conjunctival hyperemia medical

"the most common ocular adverse reactions reported in > 5% of subjects were conjunctival hyperemia"

Conjunctival hyperemia is the medical term for visible redness of the white part of the eye caused by increased blood flow in the eye’s surface vessels, similar to how skin can flush when irritated. For investors, it matters because it’s a common side effect tracked in clinical trials and product safety reports—frequent or severe cases can affect a drug or device’s regulatory approval, labeling, patient acceptance and ultimately market potential.

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PITTSBURGH, Oct. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today 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. RYZUMVI is currently approved in the United States for the treatment of pharmacologically-induced mydriasis and is the only commercially available FDA-approved product for that use. This approval expands the product's indications to include presbyopia.

Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia.

About Opus Genetics and Viatris Collaboration
Opus Genetics and Viatris Inc. (through an affiliated entity) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize the product in the United States.

About Presbyopia
Presbyopia is the gradual loss of near focusing ability due to aging, that typically becomes noticeable in the early to mid-40s. It is a nearly universal condition that, when uncorrected, contributes significantly to vision-related disability. Presbyopia leads to symptoms like eye strain and blurred near vision, impacting daily tasks and productivity.

INDICATIONS AND USAGE
RYZUMVI^® (phentolamine ophthalmic solution) 0.75% is indicated for:

• Treatment of presbyopia in adults
• Treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide) in adults and pediatric patients 3 years of age and older

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis).
Potential for Eye Injury or Contamination: To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.
Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.

Adverse Reactions
Presbyopia
The most common ocular adverse reactions reported in > 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%).
Pharmacologically-induced Mydriasis
The most common ocular adverse reactions reported in > 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%). The majority of the adverse reactions were mild, transient and self-resolving.

Please see complete Prescribing Information 

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements about the approval of RYZUMVI^® for the treatment of presbyopia in adults; and Viatris is exploring the potential for a partner in the United States to commercialize RYZUMVI for the treatment of presbyopia. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

 

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SOURCE Viatris Inc.

FAQ

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What did the FDA approve RYZUMVI for in Viatris's announcement?

The FDA approved RYZUMVI for treatment of presbyopia in adults. The approval adds an indication for phentolamine ophthalmic solution 0.75%, which was already approved in the United States for treatment of pharmacologically induced mydriasis, or drug-induced pupil dilation.