FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia

Rhea-AI Summary

Viatris (Nasdaq: VTRS) announced FDA acceptance of the supplemental New Drug Application for MR-141 (phentolamine ophthalmic solution 0.75%) for presbyopia, with a PDUFA goal date of October 17, 2026. The sNDA is supported by positive Phase 3 VEGA-2 and VEGA-3 results that met primary and all key secondary endpoints with no treatment-related serious adverse events.

Ryzumvi (phentolamine 0.75%) is already approved in the U.S. for pharmacologically-induced mydriasis; the sNDA seeks to expand the indication to include presbyopia. VEGA-3 data will be presented at ASCRS in April and ARVO in May.

Positive

• FDA accepted sNDA with a PDUFA date of Oct 17, 2026
• Phase 3 VEGA-2 and VEGA-3 met primary and all key secondary endpoints
• No treatment-related serious adverse events reported in pivotal trials
• Existing U.S. approval for Ryzumvi establishes commercial and regulatory precedent

Negative

• Regulatory outcome remains pending until the PDUFA decision on Oct 17, 2026

News Market Reaction – VTRS

+0.09%

3 alerts

+0.09% Session close to close

-4.9% Trough Tracked

$18.52B Market Cap

5.47K Volume

In the Feb 25 session, VTRS gained 0.09%, reflecting a mild positive market reaction. Argus tracked a trough of -4.9% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances Viatris’ ophthalmology pipeline, with FDA acceptance of the MR-141 sNDA a...

Analysis

This announcement advances Viatris’ ophthalmology pipeline, with FDA acceptance of the MR-141 sNDA and a PDUFA goal date of October 17, 2026. The filing leverages Phase 3 VEGA results that met all primary and key secondary endpoints without treatment-related serious adverse events, targeting presbyopia in 90% of U.S. adults over 45. Investors may track upcoming VEGA-3 data presentations and regulatory interactions to gauge progress and remaining approval risk.

Key Figures

PDUFA goal date: October 17, 2026 Presbyopia prevalence: 90% of U.S. adults over 45 VEGA-3 sample size: 545 patients +5 more

8 metrics

PDUFA goal date October 17, 2026 FDA review timeline for MR-141 sNDA in presbyopia

Presbyopia prevalence 90% of U.S. adults over 45 Target population affected by presbyopia

VEGA-3 sample size 545 patients MR-141 VEGA-3 Phase 3 presbyopia trial

VEGA-3 significance p<0.0001 Primary endpoint for MR-141 VEGA-3 trial

VEGA Phase 3 endpoints Primary and all key secondary met VEGA-2 and VEGA-3 MR-141 presbyopia trials

Serious adverse events No treatment-related serious AEs MR-141 Phase 3 presbyopia program safety

Current share price $16.07 Pre-news trading level on 2026-02-25

Q3 2025 revenue $3,759.9 million Viatris total revenues, essentially flat year over year

Previous Clinical trial Reports

5 past events · Latest: Jul 18 (Negative)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 18	Phase 3 setback	Negative	-4.2%	MR-139 Phase 3 blepharitis trial failed primary endpoint; program under review.
Jun 26	Phase 3 success	Positive	+2.6%	MR-141 VEGA-3 presbyopia trial met all endpoints with strong efficacy and safety.
Jun 02	Phase 3 success	Positive	-1.1%	Positive LYNX-2 Phase 3 results for MR-142 in night-driving impairment under SPA.
May 08	Phase 3 success	Positive	+5.7%	XULANE LO™ contraceptive patch Phase 3 showed favorable efficacy and safety profile.
May 08	Phase 3 success	Positive	+5.7%	Fast-acting meloxicam Phase 3 studies showed superior non-opioid pain control vs comparators.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical readouts for Viatris have mostly produced price moves aligned with the news tone, with only one notable divergence on a positive trial update.

Recent Company History

Recent history shows Viatris using ophthalmology and women’s health trials to build its pipeline. Positive Phase 3 data for MR-141 in presbyopia and MR-142 for night-driving impairment, plus strong readouts for XULANE LO™ and fast-acting meloxicam, all drove share gains of up to 5.7%. A failed MR-139 blepharitis study led to a -4.21% decline. Today’s sNDA acceptance and PDUFA date for MR-141 builds directly on the earlier VEGA-3 Phase 3 success in presbyopia.

Key Terms

snda, pdufa, presbyopia, phase 3, +4 more

8 terms

snda regulatory

"FDA has accepted for review the supplemental New Drug Application (sNDA) for MR-141..."

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

pdufa regulatory

"The FDA has assigned a PDUFA goal date of October 17, 2026."

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

presbyopia medical

"Presbyopia is the age-related progressive loss of the ability to focus on close objects..."

Presbyopia is the gradual loss of the eye’s ability to focus on close objects as the lens stiffens with age, causing tasks like reading or using a phone to require holding things farther away or using glasses. It matters to investors because it drives steady demand for corrective products and treatments—such as reading glasses, contact lenses, surgical procedures and emerging drugs—much like an aging population consistently needs new or replacement consumer goods and services.

phase 3 medical

"The sNDA is supported by data from the pivotal Phase 3 program, including two trials..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pharmacologically-induced mydriasis medical

"Ryzumvi ... is currently approved in the U.S. for the treatment of pharmacologically-induced mydriasis..."

Pharmacologically-induced mydriasis is the widening of the pupil caused by a drug or medication, similar to a camera lens opening wider to let in more light. For investors, it matters because drug-induced pupil dilation can be an intended treatment effect or a side effect that affects safety data, clinical trial outcomes, regulatory review, and the usability or marketability of eye-care products and medical devices.

adrenergic agonists medical

"pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine)..."

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 medical

"or parasympatholytic (e.g., tropicamide) agents, and is the only commercially available..."

A parasympatholytic is a drug that blocks the parasympathetic nervous system, the body’s “rest-and-digest” control that slows heart rate and stimulates digestion. For investors, these medicines matter because they change how a drug works and its side-effect profile—affecting safety, market size, clinical trial outcomes and regulatory decisions—so they can influence a product’s commercial prospects the same way turning down a home thermostat changes overall comfort and energy use.

ophthalmic solution medical

"MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia."

An ophthalmic solution is a liquid medicine formulated to be placed in the eye, like eye drops, used to treat conditions such as infections, inflammation, pressure changes, or dry eye. Investors track these products because their approval, safety record, manufacturing quality and patent status determine sales potential and competition—think of it like a packaged household remedy whose shelf life, rules and maker reputation affect its market value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FDA PDUFA Goal Date Set for October 17, 2026

PITTSBURGH, Feb. 25, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia is the age-related progressive loss of the ability to focus on close objects that results in blurred near vision and eye strain. The condition affects approximately 90% of adults in the U.S. over the age of 45.

"FDA's acceptance of this supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for presbyopia is evidence of the continued execution of our innovative pipeline," said Philippe Martin, Viatris Chief R&D Officer. "We are confident in the strength of the clinical data supporting our submission. Phentolamine offers a physiological approach that relaxes the iris dilator muscle to improve near vision without engaging the ciliary muscle, which helps preserve distance vision. We look forward to working with the FDA during the review as we pursue a new treatment option for the millions of patients who face blurred near vision."

The sNDA is supported by data from the pivotal Phase 3 program, including two trials, VEGA-2 and VEGA-3. Both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events. Data from VEGA-3 will be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May in Denver, Colorado.

Ryzumvi^® (phentolamine ophthalmic solution 0.75%) is currently approved in the U.S. for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, and is the only commercially available FDA-approved product for this use. The sNDA seeks to expand the indication to include presbyopia.

Opus Genetics and Viatris (through its affiliate) 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 phentolamine ophthalmic solution 0.75% in the U.S.

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. It affects nearly 128 million people in the United States—about 90% of adults over the age of 45. By age 50, most Americans require some form of near-vision correction, such as reading glasses or multifocal lenses. Globally, an estimated 1.8 billion people were presbyopic in 2015, projected to rise to 2.1 billion by 2030.

RYZUMVI® 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
The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).

Please see Full Prescribing Information

About Viatris 
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. 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 that the FDA has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia; the FDA has assigned a PDUFA goal date of October 17, 2026; FDA's acceptance of this sNDA for phentolamine ophthalmic solution 0.75% for presbyopia is evidence of the continued execution of our innovative pipeline; we are confident in the strength of the clinical data supporting our submission; we look forward to working with the FDA during the review as we pursue a new treatment option for the millions of patients who face blurred near vision; both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events; data from VEGA-3 will be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May in Denver, Colorado; Ryzumvi^® (phentolamine ophthalmic solution 0.75%) is currently approved in the U.S. for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, and is the only commercially available FDA-approved product for this use; the sNDA seeks to expand the indication to include 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: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; 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; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; 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

What did Viatris (VTRS) announce about MR-141 on February 25, 2026?

Viatris announced FDA acceptance of the sNDA for MR-141 (phentolamine 0.75%) for presbyopia. According to the company, the FDA set a PDUFA goal date of October 17, 2026 and the submission is supported by positive Phase 3 data.

What did the Phase 3 VEGA-2 and VEGA-3 trials show for MR-141 (VTRS)?

Both Phase 3 trials met the primary and all key secondary endpoints. According to the company, trials reported positive efficacy and no treatment-related serious adverse events in the pivotal program.

How could the FDA decision timeline affect Viatris (VTRS) investors?

The regulatory review is active with a set decision date of October 17, 2026. According to the company, that PDUFA date will determine approval timing and potential commercial launch planning for presbyopia.

Is Ryzumvi already approved in the U.S. and how does that relate to the sNDA?

Yes, Ryzumvi (phentolamine 0.75%) is approved for pharmacologically-induced mydriasis in the U.S. According to the company, the sNDA seeks to expand the existing label to include presbyopia.

When and where will Viatris present additional MR-141 data from VEGA-3?

VEGA-3 data will be presented in April at ASCRS and in May at ARVO. According to the company, these presentations will disclose additional trial details to clinicians and investors.