Latest news with #Viatris
Yahoo
2 days ago
- Business
- Yahoo
Viatris' blepharitis ointment fails Phase III trial
Viatris' investigational blepharitis ointment failed to achieve the primary endpoint in its Phase III trial, prompting the company to reconsider the drug's future. The Phase III study (NCT06400511) evaluated the efficacy and safety of MR-139 (pimecrolimus 0.3%) ophthalmic ointment in 477 patients with the condition. Blepharitis usually affects both eyes along the edges of the eyelids and results from clogged oil glands at the base of the eyelashes. The study failed to reach the primary endpoint of complete resolution of debris after six weeks of twice-daily dosing. After the failure was announced, Viatris' stock dropped 4.2%, from $9.27 at market close on 17 July to $8.88 at market close on 18 July. The US company has a market cap of $10.42bn. Viatris' chief R&D officer Philippe Martin said the company is currently working out the next steps for MR-139 in blepharitis. Martin said: "Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase III programme, which may include revising the planned additional Phase III study.' A cream formulation of pimecrolimus, marketed as Eildel, was approved in 2001 for use in a number of dermatology indications by Novartis. Generics have since been approved by companies, including Teva Pharmaceuticals and Glenmark Therapeutics. The therapy has not been approved in any ophthalmology indications. Last month, the company's phentolamine ophthalmic solution 0.75% was successful in a second Phase III presbyopia study, with the company eyeing FDA approval of the therapy. In the same month, Viatris also had success in the Phase III LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions. Approved treatments for blepharitis include steroid eyedrops and topical antibiotics; however, in some circumstances, oral antibiotics may also be prescribed. For Demodex blepharitis, Tarsus Pharmaceuticals' Xdemvy (lotilaner ophthalmic solution) is prescribed to target and eliminate the mites on the eyelashes responsible for the condition. GlobalData predicts Xdemvy to reach blockbuster status in 2030, with a global sales forecast of $1.03bn. GlobalData is the parent company of Clinical Trials Arena. "Viatris' blepharitis ointment fails Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
4 days ago
- Business
- Yahoo
Viatris Stock Slides After Phase 3 Blepharitis Drug Trial Misses Key Target
Viatris (VTRS, Financials) shares fell 3.6% on Friday after the firm said that its late-stage clinical study of the blepharitis medication MR-139 did not fulfill its main goal. The study examined pimecrolimus 0.3% ophthalmic ointment on 477 individuals for 12 weeks. Its goal was to get rid of eyelid debris, which is a major sign of blepharitis, but it didn't completely go away after six weeks of is currently thinking about its choices. The company's Chief R&D Officer said that the team might change its plans for future MR-139 trials. Viatris is still hopeful, even though this setback. Its pipeline still contains potential therapies like Tyrvaya and RYZUMVI, and it recently published good findings from two other Phase 3 studies, LYNX-2 and VEGA-3, which were looking at keratorefractive problems and presbyopia, company's long-term plan is still to work on treatments for anterior segment disorders in ophthalmology, and management have said they will keep working on these unmet requirements. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis
PITTSBURGH, July 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. Viatris Chief R&D Officer Philippe Martin said, "Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study. Thank you to the patients and investigators who contributed to the trial." The Company is focused on delivering novel therapies like Tyrvaya® and RYZUMVI®, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions. In June 2025, Viatris announced positive top-line results from its Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions. The Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia. About the MR-139 3001 Phase 3 StudyThe MR-139 3001 Phase 3 trial consisted of a randomized, placebo-controlled, double-masked prospective study, with a total of 477 patients who were randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily, treated and observed over 12 weeks. For more information on the MR-139 study design, refer to (NCT06400511). About ViatrisViatris 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 and and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking StatementsThis 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 a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing; given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study; the Company is focused on delivering novel therapies like Tyrvaya® and RYZUMVI®, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions; in June 2025, Viatris announced positive top-line results from its Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions; and the Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating 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. View original content to download multimedia: SOURCE Viatris Inc. Sign in to access your portfolio
Reuters
4 days ago
- Health
- Reuters
US FDA advisers recommend against Otsuka's PTSD combination treatment
July 18 (Reuters) - The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's (4578.T), opens new tab antipsychotic drug in combination with Viatris' (VTRS.O), opens new tab antidepressant Zoloft for treating adults with PTSD. The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination with Zoloft, chemically known as sertraline, for treating the condition. Its decision is in line with the FDA staff reviewers' assessment on Wednesday. Otsuka's application was based on the data from one mid-stage and two late-stage studies testing the combination treatment compared to sertraline plus placebo. It had failed to meet the main goal of significantly reducing severity of PTSD symptoms in one of the late-stage studies compared to sertraline and placebo. PTSD, a disorder caused by very stressful events, affects about 4% of U.S. adults and is commonly associated with war veterans. But natural disasters, abuse or other trauma may also trigger the condition in civilians. "We simply cannot negate one negative study and say we are going to approve based on two other positive studies," said panelist Pamela Shaw, biostatistician at Kaiser Permanente. Otsuka did not immediately respond to a Reuters request for comment. The advisers discussed possible side-effects such as weight gain and movement disorders associated with long-term use of antipsychotics, but noted that the combination may be a better treatment option for patients who respond poorly to sertraline alone. "The big question for me is knowing that antipsychotics can cause real problems, especially with long-term use, and the modest benefit that the combination treatment potentially can offer," said panelist Walter Dunn, assistant clinical professor of psychiatry at university of California Los Angeles. The FDA, originally set to decide on the company's application by February 8, delayed its decision to seek the advisory panel's input. The agency has not set a new action date for the drug. The health regulator typically follows the advice of its expert advisers, but is not required to do so. If approved, the combination drug would be the first PTSD treatment to gain U.S. nod in more than two decades after Zoloft and GSK's (GSK.L), opens new tab Paxil. Brexpiprazole, branded as Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer's disease as well as for adults with major depressive disorder and schizophrenia. The drug is being co-developed by Otsuka and Danish drugmaker Lundbeck ( opens new tab.
Yahoo
4 days ago
- Business
- Yahoo
Viatris Stock Slides After Phase 3 Blepharitis Drug Trial Misses Key Target
Viatris (VTRS, Financials) shares fell 3.6% on Friday after the firm said that its late-stage clinical study of the blepharitis medication MR-139 did not fulfill its main goal. The study examined pimecrolimus 0.3% ophthalmic ointment on 477 individuals for 12 weeks. Its goal was to get rid of eyelid debris, which is a major sign of blepharitis, but it didn't completely go away after six weeks of is currently thinking about its choices. The company's Chief R&D Officer said that the team might change its plans for future MR-139 trials. Viatris is still hopeful, even though this setback. Its pipeline still contains potential therapies like Tyrvaya and RYZUMVI, and it recently published good findings from two other Phase 3 studies, LYNX-2 and VEGA-3, which were looking at keratorefractive problems and presbyopia, company's long-term plan is still to work on treatments for anterior segment disorders in ophthalmology, and management have said they will keep working on these unmet requirements. This article first appeared on GuruFocus. Sign in to access your portfolio
