Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia

Rhea-AI Summary

Viatris (NASDAQ:VTRS) announced positive top-line results from its VEGA-3 Phase 3 trial for MR-141, a treatment for presbyopia. The randomized, placebo-controlled study involving 545 patients met its primary and all secondary endpoints, demonstrating significant improvement in near vision without compromising distance vision.

The trial showed statistically significant results (p<0.0001) in achieving ≥3-line gain in binocular distance-corrected near visual acuity. Patients reported significant functional benefits and satisfaction with near vision improvements, particularly in dim lighting conditions. The safety profile remained consistent with previous trials, with no treatment-related serious adverse events.

Viatris plans to submit an FDA application in H2 2025 for MR-141, targeting a condition that affects approximately 90% of U.S. adults over 45.

Positive

• Met primary and all secondary endpoints in Phase 3 VEGA-3 trial
• Demonstrated statistically significant improvement in near vision (p<0.0001)
• No evidence of tachyphylaxis observed during 6-week follow-up
• Targeting large market opportunity with 90% of U.S. adults over 45 affected by presbyopia
• Safety profile consistent with previous trials with no serious adverse events

Negative

• Most common adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia
• FDA application not planned until second half of 2025
• Long-term safety monitoring still ongoing for 48 weeks

Insights

Pharmaceutical Research Analyst

Viatris' MR-141 shows strong Phase 3 efficacy for presbyopia, advancing toward FDA filing with positive commercial potential.

Viatris' second pivotal Phase 3 trial (VEGA-3) for MR-141 has delivered statistically significant results across all endpoints, positioning the company to file with the FDA in H2 2025. The trial demonstrated meaningful clinical benefits with p<0.0001 for the primary endpoint of improved near vision without compromising distance vision, showing both rapid onset (1-hour post-dose) and sustained efficacy (12 hours post-dose).

The results are particularly compelling as MR-141 addresses a massive market opportunity - presbyopia affects approximately 90% of adults over 45 in the US alone. What sets this candidate apart is the benefit in dim/low light conditions where presbyopia symptoms typically worsen, and the absence of tachyphylaxis (diminishing response) during the 6-week follow-up.

The safety profile appears favorable with no treatment-related serious adverse events and predominantly mild side effects like conjunctival hyperemia (eye redness) and instillation site irritation. The low headache rate of 2.6% is noteworthy as competing treatments have reported higher incidences.

Unlike invasive surgical approaches, this daily eye drop represents a convenient non-invasive option. The licensing agreement with Opus Genetics grants Viatris exclusive commercialization rights in the US, potentially creating a new revenue stream if approved. The ongoing 48-week safety monitoring will provide additional long-term safety data to support the regulatory submission planned for later this year.

MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision

Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study

Targeting Application To U.S. FDA In Second Half of 2025

PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from VEGA-3, the second pivotal Phase 3 trial evaluating MR-141 (phentolamine ophthalmic solution 0.75%) in treating presbyopia. Presbyopia is the progressive loss of the ability to focus on close objects that results in blurred near vision and eye strain, particularly in dim lighting conditions.

The VEGA-3 Phase 3 trial is a randomized, placebo-controlled, double-blind study, with a total of 545 patients who were randomized 3:2 to receive either MR-141 or placebo, once daily in the evening. In summary:

• Significantly more patients treated in the MR-141 arm achieved the primary endpoint of Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) gain in binocular distance-corrected near visual acuity (DCNVA) and with less than 5 letters of loss in binocular best-corrected distance visual acuity (BCDVA) from baseline at 12 hours post-dose on Day 8, compared to placebo (p<0.0001).
  
  
• Significantly more patients treated in the MR-141 arm achieved ≥15-letters ETDRS (≥3-line) gain in DCNVA and with less than 5 letters of loss in BCDVA at 1-hour post-dose on Day 1 compared to those receiving placebo (p=0.0002).
  
  
• Significant patient-reported functional benefit at Days 3, 8, and Week 6 were observed with patients reporting satisfaction with near vision upon awakening (p<0.0001) and satisfaction with their improvement in near vision (p<0.0001).
  
  
• Patient reported significant improvement in near vision in dim/low light at Days 3, 8 and Week 6 compared with placebo (p<0.0001).
  
  
• No evidence of tachyphylaxis was observed during 6-week follow up.
  
  
• MR-141 demonstrated a safety profile consistent with previous trials, with no new safety signal identified and no treatment-related serious adverse events reported in this study. The most common (≥5%) treatment-emergent adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia and were predominantly mild. Low rate of headache (2.6%) was reported over the study period.  

Viatris Chief R&D Officer Philippe Martin said, "Presbyopia is a very common condition affecting approximately 90 percent of adults in the U.S. over the age of 45, who often experience blurred near vision and eye strain. We are pleased with the positive results from the second pivotal Phase 3 trial, which reinforce our confidence in MR-141 and its benefit-risk profile as a potential, non-invasive option to support the millions of patients impacted by this condition."

VEGA-3 patients will continue to be monitored for long-term safety over 48 weeks. For more information on the VEGA-3 study design, refer to ClinicalTrials.gov (NCT06542497).

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. The condition is associated with reduced quality of life, functional independence, and work efficiency. It affects nearly 128 million people in the United States—about 90% of adults over 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. With global productivity losses estimated at $11–25 billion due to uncorrected cases, there is significant economic consequences from lost productivity and increased healthcare utilization. Timely access to affordable near-vision correction is essential to reducing its impact.

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 (formerly Twitter).

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 outcome of clinical trials; that MR-141 met primary and all secondary endpoints, demonstrating rapid and sustained improvement in near visual acuity without compromising distance vision; safety profile consistent with previous clinical trials and no treatment-related serious adverse events reported in this study; targeting application to U.S. FDA in second half of 2025; and we are pleased with the positive results from the second pivotal Phase 3 trial, which reinforce our confidence in MR-141 and its benefit-risk profile as a potential, non-invasive option to support the millions of patients impacted by this condition . 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 were the key results of Viatris (VTRS) VEGA-3 Phase 3 trial for MR-141?

The trial met its primary endpoint with significantly more patients achieving ≥3-line gain in near visual acuity without compromising distance vision. The study demonstrated statistically significant results (p<0.0001) and consistent safety profile with no serious adverse events.

When will Viatris (VTRS) submit MR-141 for FDA approval?

Viatris plans to submit the FDA application for MR-141 in the second half of 2025.

What is the market potential for Viatris's MR-141 presbyopia treatment?

MR-141 targets presbyopia, which affects approximately 90% of U.S. adults over age 45, representing a significant market opportunity for a non-invasive treatment option.

What were the side effects reported in Viatris's MR-141 VEGA-3 trial?

The most common side effects (≥5%) included conjunctival hyperemia, instillation site irritation, and dysgeusia, which were predominantly mild. Headache was reported at a low rate of 2.6%.

How many patients participated in Viatris's VEGA-3 trial for MR-141?

The VEGA-3 Phase 3 trial included 545 patients who were randomized 3:2 to receive either MR-141 or placebo.