Viatris Inc【VTRS】株式ニュース

Viatris Announces Several Data Presentations on Investigational Low-Dose Estrogen Combined Hormonal Contraceptive Weekly Patch at the 2026 American College of Obstetricians and Gynecologists Annual Clinical & Scientific MeetingMay 1, 2026 6:59 AM
PR Newswire (US)

PITTSBURGH, May 1, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that six abstracts on its investigational low-dose estrogen combined hormonal contraceptive (CHC) weekly patch will be presented at the 2026 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting (ACSM) in Washington, D.C., May 1-3, 2026.The presentations will include positive results from the previously announced Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of the Company's investigational low-dose estrogen CHC weekly patch. In addition, presentations will highlight new data on the patch's adhesion profile under normal and under extreme conditions, as well as pharmacokinetic data and data on cycle control.All accepted scientific abstracts are available on the ACOG Annual Meeting website.Full List of Viatris Presentations at 2026 ACOG ACSM:AbstractAbstract DetailsAbstract No. E26Patch Adhesion Performance of a Low-Dose
Estrogen Transdermal Contraceptive System MR-
100A-01Electronic PosterIndustry ePoster Session E (IEP05)Saturday, May 28–9 a.m. EDTAbstract No. E27No impact on adhesion performance and
pharmacokinetics of MR-100A-01 contraceptive
patch under extreme conditionsElectronic PosterIndustry ePoster Session E (IEP05)Saturday, May 28–9 a.m. EDTAbstract No. G19Contraceptive Efficacy of MR-100A-01 in Women of
Childbearing Potential: Results from a Phase 3
StudyElectronic PosterIndustry ePoster Session G (IEP07)Saturday, May 21:30–2:30 p.m. EDTAbstract No. G20MR-100A-01 Weekly Transdermal Contraceptive
System: Safety Insights from a Phase 3 TrialElectronic PosterIndustry ePoster Session G (IEP07)Saturday, May 21:30–2:30 p.m. EDTAbstract No. G21MR-100A-01 Weekly Transdermal Contraceptive
System: Cycle Control Data from a Phase 3 TrialElectronic PosterIndustry ePoster Session G (IEP07)Saturday, May 21:30–2:30 p.m. EDTAbstract No. G22Comparison of the multiple-dose pharmacokinetics
of norelgestromin and ethinyl estradiol following
administration of MR-100A-01, a once-weekly
contraceptive transdermal system, and once daily
administration of oral contraceptive tabletsElectronic PosterIndustry ePoster Session G (IEP07)Saturday, May 21:30–2:30 p.m. EDTIn complement to its scientific program, and to further foster peer-to-peer exchange and support clinicians in the evolving landscape of non-oral contraceptive options, Viatris provided an independent educational grant for the following educational symposium hosted by PRIME®, a nationally recognized continuing medical education platform:Contraceptive Considerations in the Modern Era: Navigating Non-Oral Options and Evolving Clinical ComplexitiesFriday, May 16–7:30 p.m. ETMarriott Marquis Washington, D.C., Salon 5 (Meeting Level 2)More information on the data presentations and symposium can be found on the ACOG ACSM website here, and Viatris can be found at booth #223.About Low-Dose Estrogen Combined Hormonal Contraceptive Weekly Patch
The investigational treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception (CHC) and who prefer a non-invasive, reversible option with a lower estrogen dose. The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low-dose estrogen CHC weekly patch. The NDA is accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a target action date (PDUFA) of July 30, 2026. The NDA is supported by results from a multicenter, open-label, single-arm, Phase 3 study (NCT05139121), which evaluated the safety and contraceptive efficacy of the investigational low-dose estrogen CHC weekly patch, and which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance.The investigational low-dose estrogen CHC weekly patch aims to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance. This investigational treatment option builds upon the Company's established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch, Xulane® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day.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 dynamic portfolio that spans generics, 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, China, 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 investigational low-dose estrogen combined hormonal contraceptive (CHC) weekly patch; the outcomes of clinical trials; FDA has accepted for review the NDA for the Company's investigational low-dose estrogen CHC weekly patch; the NDA is accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a target action date (PDUFA) of July 30, 2026; the NDA is supported by results from a multicenter, open-label, single-arm, Phase 3 study (NCT05139121), which evaluated the safety and contraceptive efficacy of the investigational low-dose estrogen CHC weekly patch and which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance; the investigational low-dose estrogen CHC weekly patch aims to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance; this investigational treatment option builds upon the Company's established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch, Xulane® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day. 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; 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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Original: Viatris Announces Several Data Presentations on Investigational Low-Dose Estrogen Combined Hormonal Contraceptive Weekly Patch at the 2026 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting

Viatris Announces Multiple Data Presentations at the 2026 American Society of Cataract and Refractive Surgery Annual MeetingApril 10, 2026 6:59 AM
PR Newswire (US)

PITTSBURGH, April 10, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that four abstracts will be presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Washington, D.C., April 10-13, 2026.The presentations will include data across various areas of ophthalmology, including full results from VEGA-3, a Phase 3 study evaluating MR-141 (phentolamine ophthalmic solution 0.75%) for presbyopia; results from a Phase 1 study of varenicline solution nasal spray in healthy Japanese adults; and a post-hoc analysis of MIRA-2, a Phase 3 study evaluating the optical impact of RYZUMVI® for reversing pharmacologically-induced mydriasis. Additional data will include an encore presentation of LYNX-2, a Phase 3 study evaluating MR-142 (phentolamine ophthalmic solution 0.75%) for visual disturbances in low light conditions in post-refractive surgery patients.All accepted scientific abstracts are available on the ASCRS Annual Meeting website.Full List of Viatris Presentations at ASCRS Annual Meeting 2026:AbstractAbstract DetailsAbstract No. 123806Optical Impact of Reversing Pharmacologically
Induced Mydriasis on Image QualityElectronic Poster (On-Demand)Friday, April 10Room: WEWCCAbstract No. 121513 Changes in Tear Meniscus Height after a Single-
Dose of Varenicline Solution Nasal Spray in Healthy
Japanese Adult VolunteersElectronic Poster (On-Demand)Friday, April 10Room: WEWCCAbstract No. 119626 Phentolamine Ophthalmic Solution Provides
Durable Improvement in Distance Corrected Near
Vision for Presbyopic Patients in a Phase 3 StudyOral PresentationPaper Session: Presbyopia Correction
- Digital & Other Saturday, April 118–8:05 a.m. ETRoom: WEWCC - Level 2, 209CAbstract No. 119714 Phase 3 Randomized Controlled Study of
Phentolamine Ophthalmic Solution in Post-
Refractive Surgery Patients with Impaired
Mesopic VisionOral PresentationPaper Session: Refractive
Complications, Digital, & Other Saturday, April 118:20–8:25 a.m. ETRoom: WEWCC - Level 2, 209ATo complement its scientific program, and to further foster peer-to-peer exchange and support clinicians in the evolving management of presbyopia, Viatris provided an independent educational grant for the following educational symposium hosted by PRIME®, a nationally recognized continuing medical education platform:Presbyopia Re-Envisioned: A New Era of Pharmacological Vision CorrectionSaturday, April 116–7:30 p.m. ETThe Westin DC Downtown, River Birch BallroomMore information on the data presentations and symposium can be found on the ASCRS website here, and Viatris can be found at booth #233.All educational content of the ASCRS Annual Meeting is planned by its Program Committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services.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 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 InformationAbout Mesopic Vision
Mesopic vision is defined as vision in dim light (interface of bright light and night vision) conditions that leverages both rod and cone photoreceptors. Decreased low contrast visual acuity under mesopic conditions occurs when the pupil dilates in low-light conditions allowing peripheral unfocused rays of light to enter the eye. The total diagnosed prevalence of Night Vision Disturbance (NVD) across the 7 Major Markets (United States, United Kingdom, Germany, France, Italy, Spain, and Japan) was estimated to be nearly 55 million in 2023, with the U.S. representing approximately 45% of cases. The condition is particularly common in patients with increased ocular aberrations and ocular scatter from keratorefractive surgery (including Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Small-Incision Lenticule Extraction (SMILE), and Radial Keratotomy (RK)). It is estimated that approximately 800,000 refractive surgeries are performed in the U.S. each year, with 25% of patients suffering from visual aberrations (e.g., glare, halos, starburst) at 1-month. There are currently no FDA-approved treatments.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 deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, 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, China, 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 presentations, study results, and licensing agreements. 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; 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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Original: Viatris Announces Multiple Data Presentations at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting