Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia
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.
Viatris (NASDAQ:VTRS) ha annunciato risultati positivi preliminari dal suo studio di fase 3 VEGA-3 per MR-141, un trattamento per la presbiopia. Lo studio randomizzato e controllato con placebo, che ha coinvolto 545 pazienti, ha raggiunto l'endpoint primario e tutti quelli secondari, dimostrando un miglioramento significativo della vista da vicino senza compromettere la vista da lontano.
Lo studio ha evidenziato risultati statisticamente significativi (p<0,0001) nel raggiungimento di un guadagno di ≥3 linee nell'acuità visiva binoculare corretta per la distanza da vicino. I pazienti hanno riportato benefici funzionali significativi e soddisfazione per il miglioramento della vista da vicino, specialmente in condizioni di scarsa illuminazione. Il profilo di sicurezza è rimasto coerente con studi precedenti, senza eventi avversi gravi correlati al trattamento.
Viatris prevede di presentare una domanda alla FDA nella seconda metà del 2025 per MR-141, rivolgendosi a una condizione che colpisce circa il 90% degli adulti statunitensi sopra i 45 anni.
Viatris (NASDAQ:VTRS) anunció resultados positivos preliminares de su ensayo de fase 3 VEGA-3 para MR-141, un tratamiento para la presbicia. El estudio aleatorizado y controlado con placebo, que incluyó a 545 pacientes, cumplió con su objetivo principal y todos los secundarios, demostrando una mejora significativa en la visión cercana sin afectar la visión a distancia.
El ensayo mostró resultados estadísticamente significativos (p<0.0001) en alcanzar una ganancia de ≥3 líneas en la agudeza visual binocular corregida para la distancia cercana. Los pacientes reportaron beneficios funcionales significativos y satisfacción con las mejoras en la visión cercana, especialmente en condiciones de poca luz. El perfil de seguridad se mantuvo consistente con estudios previos, sin eventos adversos graves relacionados con el tratamiento.
Viatris planea presentar una solicitud a la FDA en la segunda mitad de 2025 para MR-141, dirigido a una condición que afecta aproximadamente al 90% de los adultos en EE.UU. mayores de 45 años.
Viatris (NASDAQ:VTRS)는 노안 치료제인 MR-141에 대한 VEGA-3 3상 시험의 긍정적인 초기 결과를 발표했습니다. 무작위 배정, 위약 대조 연구로 545명의 환자가 참여했으며, 1차 및 모든 2차 평가변수를 충족하여 원거리 시력을 저해하지 않으면서 근거리 시력에서 유의미한 개선을 보였습니다.
시험 결과는 근거리 교정 시력에서 ≥3줄 이상의 개선을 달성하는 데 있어 통계적으로 유의미한 결과(p<0.0001)를 나타냈습니다. 환자들은 특히 어두운 환경에서 근거리 시력 개선에 따른 기능적 이점과 만족도를 보고했습니다. 안전성 프로필은 이전 시험과 일치하며, 치료 관련 중대한 이상 반응은 없었습니다.
Viatris는 2025년 하반기에 MR-141에 대한 FDA 신청을 계획하고 있으며, 이는 약 45세 이상 미국 성인의 90%가 겪는 상태를 대상으로 합니다.
Viatris (NASDAQ:VTRS) a annoncé des résultats positifs préliminaires de son essai de phase 3 VEGA-3 pour MR-141, un traitement contre la presbytie. L'étude randomisée et contrôlée par placebo, impliquant 545 patients, a atteint son critère principal et tous les critères secondaires, démontrant une amélioration significative de la vision de près sans compromettre la vision de loin.
L'essai a montré des résultats statistiquement significatifs (p<0,0001) pour un gain ≥3 lignes en acuité visuelle binoculaire corrigée pour la distance de près. Les patients ont rapporté des bénéfices fonctionnels importants et une satisfaction quant à l'amélioration de la vision de près, notamment en conditions de faible luminosité. Le profil de sécurité est resté conforme aux essais précédents, sans événements indésirables graves liés au traitement.
Viatris prévoit de soumettre une demande à la FDA au second semestre 2025 pour MR-141, ciblant une condition qui affecte environ 90 % des adultes américains de plus de 45 ans.
Viatris (NASDAQ:VTRS) gab positive Zwischenergebnisse aus der Phase-3-Studie VEGA-3 für MR-141 bekannt, eine Behandlung für Presbyopie. Die randomisierte, placebokontrollierte Studie mit 545 Patienten erreichte sowohl den primären als auch alle sekundären Endpunkte und zeigte eine signifikante Verbesserung des Nahsehens, ohne das Fernsehen zu beeinträchtigen.
Die Studie erzielte statistisch signifikante Ergebnisse (p<0,0001) beim Erreichen eines ≥3-Linien-Gewinns in der binokularen, distanzkorrigierten Nahsehschärfe. Die Patienten berichteten von deutlichen funktionellen Vorteilen und Zufriedenheit mit den Verbesserungen des Nahsehens, insbesondere bei schlechten Lichtverhältnissen. Das Sicherheitsprofil entsprach den vorherigen Studien, ohne behandlungsbedingte schwerwiegende Nebenwirkungen.
Viatris plant, im zweiten Halbjahr 2025 einen FDA-Antrag für MR-141 einzureichen, der sich an eine Erkrankung richtet, die etwa 90 % der US-Erwachsenen über 45 Jahre betrifft.
- 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
- 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
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
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
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
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
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
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
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SOURCE Viatris Inc.
FAQ
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