To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

开始日期2023-12-27

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT06054217

/ Active, not recruiting临床2期

Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.

开始日期2023-08-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

NCT05838170

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea

This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).

开始日期2023-03-01

申办/合作机构

Tarsus Pharmaceuticals, Inc.

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项与洛替拉纳相关的文献（医药）

2025-03-01·Ophthalmology and Therapy

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials

Article

作者: Dhamdhere, Kavita ; Simmons, Blake ; Peterson, Jared D ; Whitson, William E ; Boehmer, Blair E ; Berdy, Gregg J ; Neervannan, Sesha ; Yeu, Elizabeth ; Meyer, John ; Ciolino, Joseph B ; Paauw, James D ; Whitley, Walter O ; Periman, Laura M ; Koetting, Cecelia ; Bloomenstein, Marc R ; Vollmer, Patrick

INTRODUCTION:

Lotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.

METHODS:

Pooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.

RESULTS:

Overall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.

CONCLUSIONS:

Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.

2025-02-01·EXPERIMENTAL PARASITOLOGY

Efficacy of lotilaner for treating rabbits naturally infested by Psoroptes ovis and Leporacarus gibbus, in Rio de Janeiro, Brazil

Article

作者: Scott, Fabio B ; Lopes, Natália L ; Campos, Diefrey R ; Borges, Debora A ; Fernandes, Julio I ; Machado, Marília A

The aim of this study was to evaluate the efficacy of a single 20 mg/kg dose of lotilaner for treating rabbits with concomitant infection by P. ovis and L. gibbus. Fourteen rabbits with diagnoses of otitis and fur infection, caused respectively by P. ovis and L. gibbus, were included. Samples of otic crust were collected with tweezers, weighed and examined microscopically to identify ectoparasites, which were counted to determine the number of mites per gram of crust. Hair samples were collected from three areas of 1 cm² in different regions of the body, for examination under a stereomicroscope to determine occurrences of the mite L. gibbus. The animals in the treated group received a single oral dose of 20 mg/kg of lotilaner and were evaluated on days 0, +3, +7, +14, +21, +28 and + 35. Parasitological efficacy of 100% for controlling P. ovis was observed after seven days. Total clinical remission was reached 14 days after treatment. For L. gibbus, parasitological cure was obtained seven days after treatment. We concluded that a single dose of lotilaner was effective for controlling P. ovis and L. gibbus, leading to parasitological control and clinical improvement of the animals.

2024-12-30·Journal of Chinese Pharmaceutical Sciences

Efficacy and safety of lotilaner ophthalmic solution in the treatment of Demodex Blepharitis: a meta-analysis of randomized controlled trials

作者: Lu, Xiaojing ; Zhang, Qiwen ; Yang, Yongjie ; Lu, Jingli ; Liu, Kefeng ; Zhou, Qi ; Yang, Jing ; Kang, Jian

In this meta-anal., our aim was to systematically evaluate the efficacy and safety of lotilaner ophthalmic solution in treating Demodex Blepharitis (DB), with the goal of providing evidence for clin. practice.PubMed, Embase, Web of Science, The Cochrane Library, CNKI, Wanfang, and CBM were searched from inception to Nov. 28, 2023.Randomized controlled trials (RCTs) comparing lotilaner ophthalmic solution (exptl. group) with placebo (control group) for the treatment of DB were included.Two researchers independently screened the literature, extracted the data, and assessed the quality of the included studies.Meta-anal. was conducted using RevMan 5.4 software.The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to evaluate the evidence quality of outcomes.Publication bias was assessed using a funnel plot.Four RCTs involving 947 patients were included.Meta-anal. revealed that compared to placebo, lotilaner ophthalmic solution significantly increased the rate of mite eradication (RR=3.61, 95% CI (2.90, 4.49), P<0.00001).Addnl., lotilaner treatment resulted in higher rates of collarette cure, erythema cure, composite erythema/collarette cure, and clin. meaningful collarette cure; the differences were statistically significant, with effect sizes (RR=5.74, 95% CI (4.27, 7.72), P<0.00001), (RR=3.16, 95% CI (2.18, 4.58), P<0.00001), (RR=6.75, 95% CI (3.75, 12.16), P<0.00001), and (RR=3.09, 95% CI (2.65, 3.60), P<0.00001), resp.Mite d. (MD=-1.42, 95% CI (-2.09, -0.74), P<0.0001) and collarette grade (MD=-1.51, 95% CI (-1.77, -1.25), P<0.00001) were significantly reduced.Indeed, no discernible discrepancies in the comfort levels experienced with eye drops emerged between the two groups.Although the exptl. group did exhibit a slightly higher occurrence of treatment-related adverse events, ranging from instillation site discomfort to eye discharge and eyelid swelling, these variances did not attain statistical significance.Notably, upon GRADE evaluation, the study′s evidence quality was deemed moderate, while scrutiny for publication bias revealed minimal indications thereof.In the realm of treatment, lotilaner ophthalmic solution shined as a beacon of efficacy, effectively combating mite infections and bolstering cure rates among patients with DB. Moreover, its administration was met with commendable compliance and upheld safety standards

125

项与洛替拉纳相关的新闻（医药）

2025-04-22

·ir.tarsusrx.com

Tarsus to Present Several Scientific Abstracts Highlighting the Global Prevalence of Demodex Blepharitis and the Clinical Impact of XDEMVY at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting

IRVINE, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) will present four distinct data sets highlighting the global prevalence and real-world patient burden of Demodex blepharitis, as well as the impact of XDEMVY® (lotilaner ophthalmic solution) 0.25% in addressing objective measures of disease at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting, taking place April 25-28, 2025, in Los Angeles, Calif. “From new prevalence data in Japan to real-world results in the US, the findings accepted for oral presentation at ASCRS reinforce the global burden of Demodex blepharitis and the potential of XDEMVY to deliver significant improvements in patient outcomes across multiple subtypes, including those with concomitant meibomian gland disease,” said Elizabeth Yeu, M.D., Chief Medical Officer of Tarsus. “We look forward to continuing to generate new evidence to advance the clinical understanding of XDEMVY and its potential impact on this highly prevalent eyelid disease and on the lives of patients.” Accepted abstracts include: Longitudinal Evaluation of Disease Burden and Treatment Efficacy in Patients with Demodex blepharitis: Orion Registry Interim Results Date: Sunday, April 27, 2025, 10:42 – 10:47 a.m. PT Location: Los Angeles Convention Center (LACC) – Level 2, 512 Presenter: Kendall E. Donaldson, M.D., M.S., ABO A real-world, multi-center study characterizing the burden of Demodex blepharitis, the current disease management landscape and key changes in patient outcomes after initiation of treatment with XDEMVY. Assessment of the Demodex Blepharitis Specific Symptoms: The Janus Study Date: Monday, April 28, 2025, 8:00 – 8:05 a.m. PT Location: LACC – Level 2, 506 Presenter: Nicole R. Fram, M.D., ABO A prospective, observational study that compared symptoms and clinical outcomes in patients with Demodex blepharitis to patients without Demodex blepharitis. Lotilaner Ophthalmic Solution, 0.25% for the Treatment of Demodex blepharitis Patients with Meibomian Gland Dysfunction Date: Monday, April 28, 2025, 8:33 – 8:38 a.m. PT Location: LACC – Level 2, 506 Presenter: Mitchell C. Schultz, M.D., ABO Two pooled studies that evaluated the safety and efficacy of XDEMVY in patients with Demodex blepharitis and Meibomian Gland Disease. Prevalence of Demodex blepharitis in Japan: The Elara Study Date: Monday, April 28, 2025, 10:30 – 10:35 a.m. PT Location: LACC – Level 2, 504 Presenter: Shizuka Koh, M.D., Ph.D. An observational, multicenter study highlighting the prevalence and symptomatology of Demodex blepharitis in Japan. About Demodex Blepharitis Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans, and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. About XDEMVY® XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information Indications and Usage XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex blepharitis. Important Safety Information Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. Handling the Container: Avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice: Immediately seek a physician’s advice concerning the continued use of XDEMVY if you develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions. Use with Contact Lenses: XDEMVY contains potassium sorbate, which may discolor soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information please see Full Prescribing Information available at: www.xdemvy.com. About Tarsus Pharmaceuticals, Inc. Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care and infectious disease prevention. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the timing, content, location, and presenters of scientific abstracts at an upcoming medical conference, our ability to continue to educate the market and generate data about Demodex blepharitis, the potential market size of Demodex blepharitis globally, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2024, filed on February 25, 2025, with the SEC, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contacts: Media Contact: Adrienne Kemp Sr. Director, Corporate Communications (949) 922-0801 akemp@tarsusrx.com Investor Contact: David Nakasone Head of Investor Relations (949) 620-3223 DNakasone@tarsusrx.com

临床结果

2025-03-14

·Endpoints

Altimmune to put its incretin into addiction trials; Tarsus aims to raise $125M

Plus, news about Heidelberg, Accropeutics, Allarity Therapeutics, Cadrenal and Inovio: Altimmune to test its incretin in addiction : Following the path set by Novo Nordisk last week , Altimmune said Thursday at its R&D Day that it plans to begin trials of its injectable GLP-1/glucagon agonist pemvidutide in alcohol use disorder as well as alcoholic liver disease. Stifel analysts wrote in a note on Thursday that Altimmune has animal data that suggest pemvidutide could reduce daily alcohol intake by around half. They also cautioned that additional data would be needed to validate the hypothesis. — Elizabeth Cairns Tarsus Pharmaceuticals’ expected $125 million stock sale: The drugmaker said the funds from the public offering will be used to support the US commercialization of Xdemvy, eye drops for irritation caused by tiny mites. Tarsus also said the funds will be used to advance its experimental ocular rosacea and lyme disease drugs. — Lei Lei Wu Heidelberg amends royalty deal: The company signed an agreement with HealthCare Royalty a year ago to provide royalties to Zircaix, or TLX250-CDx, an imaging agent for some kidney cancers. While the total value of the milestones remains the same at $90 million, the companies changed the deal so that Heidelberg will receive $20 million immediately rather than get $15 million as a sales milestone. They also reduced the FDA approval milestone to $70 million from $75 million. (That milestone will be further reduced if approval comes after 2025.) Heidelberg licensed the drug to Telix in 2017, and a rolling FDA submission was initiated in 2023. — Max Gelman Accropeutics raises $12M to fund IBD asset : The Series B-plus round was led by Shenzhen Capital Group and is set to extend the biotech’s cash runway into the second half of next year. The proceeds will be used for the ongoing Phase 1b trial of Accropeutics’ RIPK2 inhibitor, known as AC-101, in ulcerative colitis. Accropeutics also has a mid-stage TYK2/JAK1 inhibitor in development for psoriasis and a RIPK1 inhibitor for graft-versus-host disease. — Elizabeth Cairns Allarity Therapeutics settles with SEC: The company will pay $2.5 million to the Securities and Exchange Commission after the regulator alleged Allarity executives concealed from investors that the FDA had recommended against approving dovitinib, an experimental cancer therapy. The company did not admit or deny the allegations. — Jaimy Lee Cadrenal is still seeking a partner for tecarfarin: It wants help advancing the oral vitamin K antagonist into a pivotal trial for patients with left ventricular assist devices and other rare cardiovascular conditions. — Jaimy Lee Inovio’s DNA therapy is durable in early trial : The company said Thursday that a Phase 1 trial proves the concept of its so-called DMAbs. The DNA plasmids encoding antibodies derived from Evusheld, AstraZeneca’s Covid-19 prophylactic, were given to patients and were translated into the proteins by the patient’s own cells. All subjects who reached week 72 had biologically relevant levels of the antibodies, according to Inovio, and the expressed DMAbs bound to the SARS-CoV-2 spike protein confirmed functional activity. However, the company did not say whether the approach prevented infections . — Elizabeth Cairns

临床1期临床结果

2025-03-14

·医药魔方Invest

核药收入狂飙，远大医药净利大涨超30%

2025年3月12日，远大医药发布年报：收益116.45亿港元，同比增长约10.6%；期内溢利24.66亿港元，同比增长约31.3%。尤其亮眼的是，2024年远大医药核药抗肿瘤诊疗板块收入约5.89亿港元，同比增长176.6%，核心产品易甘泰®钇[90Y]微球注射液据称已进入快速放量期。远大医药表示，基于良好的业绩表现，今年董事会建议派发2024年度末期股息每股0.26港元，共约9.10亿港元。年报发布后，3月13日，远大医药盘中股价大涨超21%，成交额超4.6亿港元，收盘价报6.27港元，单日涨幅近19.7%。事实上，这是远大医药2021年以来首次净利润和每股收益同比增长。可见，正是易甘泰®2022年上市后的放量，帮助远大医药走出了集采阴影——当年“押宝”核药、推动创新转型的策略，在2024年看到了回报。远大医药2020年至2024年营业收入和净利润图片来源：wind 如今，“全球四家在肿瘤治疗方面实现核药商业化应用的创新药企之一”的头衔之下，远大医药持续以年超20亿港元的研发投入推进多款核药和RDC产品，可以想见，随着未来创新管线的兑现，远大医药也将完成从“传统药企并购一哥”到“创新核药一哥”的转身。核药爆发，重磅产品箭在弦上易甘泰®钇[90Y]微球注射液的销售业绩，无疑担得起“爆发力最强”的称号。 2024年，该重磅产品拿下了近5亿港元销售收入，同比增速超140%，累计治疗近2000例患者。凭借在核药领域85%的收入贡献占比，易甘泰®钇[90Y]微球注射液已成长为支撑远大医药放射性药物板块的核心支柱。作为全球唯一一款用于结直肠癌肝转移选择性内放射治疗「SIRT」的产品，易甘泰®钇[90Y]微球注射液自2022年国内获批上市后，便实现快速放量。而其出色的业绩表现，则主要得益于临床治疗优势——该产品在原发性肝癌和结肠癌肝转移领域为大量用药选择有限的患者提供了全新治疗选择，能够实现肝癌降期并帮助患者实现临床治愈，这正是过去传统治疗手段无法实现的。从年报来看，远大医药核药抗肿瘤诊疗板块共有约800名员工，其中全球销售人员便超过500人，人均销售收入近100万港元。而在易甘泰®钇[90Y]微球注射液之后，核药板块的另一款重磅产品也即将走向商业化。截至2024年年底，远大医药在RDC领域有3款产品处于临床III期阶段，分别是前列腺癌诊断核药TLX591-CDx、透明细胞肾细胞癌诊断核药TLX250-CDx和胃肠胰神经内分泌瘤治疗性核药ITM-11。其中，TLX591-CDx预计今年可以完成III期临床研究。而该药在海外市场的表现，也足见其商业前景。得益于优异的临床诊断优势，TLX591-CDx在海外上市仅两年累计取得超7亿美元收入，而作为远大医药在核药产品领域的重要合作伙伴，核药公司Telix也迎来了股价攀升，市值突破100亿澳元。今年3月份，远大医药曾1.3亿元出售Telix部分股权，所得款项则用于集团在未满足需求领域的临床开发计划，包括与Telix合作开展的项目。另外，用于诊断透明细胞肾细胞癌的RDC药物TLX250-CDx向FDA递交的新药上市申请，则已获得受理，并进入了优先审评。目前，远大医药的自研核药销售首选美国市场准入。从公开的年报交流纪要来看，远大医药希望今年起，每年至少有一个产品向FDA递交临床申请，2028-2029年，首个产品完成临床试验并向FDA递交上市申请，并凭借自身及联营公司在海外的注册临床营销体系推动自研核药出海。后来者借力强势布局事实上，在核药这一超百亿元级别的蓝海市场，远大医药并非最早的闯入者。由于核素的放射性和半衰期，注定了核药的开发和市场布局迥异于一般药物。而风险性，则决定了其在研发、生产和经营的过程中，受到多方面特殊监管，有着令人望而生畏的进入壁垒。即便层层打通全产业链关卡，拿到药品批文要想迅速实现药品销售放量，也是难乎其难。品牌认知和物流配送，都是重大障碍。过去很长时间，国内核药市场份额几乎被中国同辐和东诚药业双寡头收割。2018年起，后来者远大医药选择了“借力”，通过数起收购和合作，加速在核药领域的布局——先是收购Sirtex向核药全球化布局迈出关键一步，而后收购北京普尔伟业，获得了放射性药品生产许可证和经营许可证。拿下入场券后，远大医药下一步筹划的就是产业链和产品。一方面，它通过与江苏省原子医学研究所和中国生态环境部核与辐射安全中心形成战略合作，构建了从研发、生产到监管的完整核药产业链；另一方面，它的目光放眼全球，选择与Telix合作，引入了多款RDC药物。事实上，核药抗肿瘤诊疗板块是远大医药全球化程度最高的板块之一。过去数年里，这家药企联合Sirtex并与Telix和ITM合作，搭建了肿瘤介入技术平台和RDC技术平台。与此同时，为强化自主创新根基，远大医药携手山东大学成立了远大医药－山东大学放射药物研究院。如此种种布局，都助力了其打造“全球技术引进+本土研发迭代”的双轮驱动模式，而这正是其核药管线临床转化效率位居行业前列的关键支撑。眼下，远大医药的核药研发平台已经储备了24条创新管线，自研产品多达50%。其中，处于注册性研发阶段的管线有12条，大多处于临床后期。三大板块发力，构筑创新护城河核药之外，作为一家横跨介入诊疗科技、制药科技、生物科技三大领域的药企，远大医药同样在创新转型，主要途径便是通过快速收购引进和加速研发的方式，针对性强化呼吸及危重症和五官科领域。 2024年，呼吸及危重症板块实现收入17.1亿港元，同比增长26.9%。具体来看，其在售产品覆盖鼻炎、支气管炎、肺炎、哮喘、慢性阻塞性肺部疾患等多个适应症。核心产品切诺（桉柠蒎肠溶胶囊）、恩卓润®比斯海乐®和恩明润®比斯海乐®均为全国独家品种，处于细分领域的领先地位。从未来业绩驱动来看，其核心动力则主要来自Ryaltris®复方鼻喷剂NDA受理及对百济制药的收购。目前，远大医药已完成百济制药100%股权的变更登记，并获得其技术领先的鼻喷制剂技术平台。同时，百济制药的产品也将与远大医药的鼻喷剂形成产品组合，全面满足轻、中、重度过敏性鼻炎患者的用药需求。另一个拉动远大医药业绩增长的板块，则是五官科。其中，创新眼药领域是远大医药的重要战略方向之一。从后续产品来看，用于治疗翼状胬肉的创新改良型新药CBT-001在中国开展的III期临床研究完成了首例患者入组给药；用于眼科术后抗炎镇痛的激素纳米混悬滴眼液GPN00833完成了在中国开展的III期临床研究并成功达到了临床终点；用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 (TP-03，洛替拉纳滴眼液，0.25%)则已向药监局递交了NDA并获得受理。同时，远大医药持续拓展产业布局，于年内与联拓生物、Tarsus以及箕星药业达成战略合作，扩充了目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂酒石酸伐尼克兰鼻喷雾剂（OC-01）在内的多款全球创新产品。如今，这家药企在仿制药集采压力下，已经收到创新转型的回报。而回顾远大医药的战略布局，不难发现其业绩持续增长的背后，实则是一套清晰的逻辑，即通过全球视野布局前沿技术，再以本土化能力和自研能力将其快速实现商业化，与此同时，借助收购全方位补强。一组数据显示，2024年，远大医药在研发及项目投入的22.7亿港元，已经推动了63项重大里程碑进展，新增14款商业化产品。不过有些不足的是，远大医药2024年的毛利率出现了下滑，同比下降约4个百分点至57.9%。未来，远大医药的市场表现如何，很大程度上取决于上述产品能否转化为更多可期待的增长点，以及并购后的整合效应。我们也将继续保持关注。推荐阅读 Biotech转型CDMO成功！东曜药业2024年首次扭亏为盈超125亿元BD，让康宁杰瑞盈利了 Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期放射疗法财报上市批准

100 项与洛替拉纳相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	洛替拉纳	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
睑缘炎	美国	Tarsus Pharmaceuticals, Inc.	2023-07-24

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
蠕形螨感染	临床3期	美国	Tarsus Pharmaceuticals, Inc.	2021-04-29
莱姆病	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2023-03-14
玫瑰痤疮	临床2期	加拿大	Tarsus Pharmaceuticals, Inc.	2023-03-01
睑板腺功能障碍	临床2期	美国	Tarsus Pharmaceuticals, Inc.	2022-08-03
疟疾	临床1期	美国	Tarsus Pharmaceuticals, Inc.	2021-06-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05387083 (Corporate Publications) 人工标引	临床2期	莱姆病	-	lotilaner high dose	製簾鹹選蓋夢襯範膚製(壓醖壓餘遞鹽構淵願艱) = 襯艱餘簾憲鏇遞憲築鬱鑰餘糧觸觸遞鑰鹽壓淵 (齋簾願積鑰淵艱築繭鏇, 1.4) 更多	积极	2024-02-22
				lotilaner low dose	製簾鹹選蓋夢襯範膚製(壓醖壓餘遞鹽構淵願艱) = 製夢夢觸簾憲憲憲構簾鑰餘糧觸觸遞鑰鹽壓淵 (齋簾願積鑰淵艱築繭鏇, 6.3) 更多
NCT04475432 (Saturn-1, CTgov)	临床2/3期	蠕形螨感染 \| 睑缘炎	421	TP-03, 0.25% (Active)	積簾鑰鹽範鹽衊膚網願(鏇襯獵夢鑰願齋繭鏇廠) = 壓廠觸顧構壓衊鹽糧窪網鑰蓋壓窪衊鹽夢蓋鹹 (鹹憲廠網艱淵醖廠遞廠, 0.034) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	積簾鑰鹽範鹽衊膚網願(鏇襯獵夢鑰願齋繭鏇廠) = 壓鬱廠艱遞選壓蓋糧醖網鑰蓋壓窪衊鹽夢蓋鹹 (鹹憲廠網艱淵醖廠遞廠, 0.018) 更多
NCT04784091 (Saturn-2, CTgov)	临床3期	蠕形螨感染 \| 睑缘炎	412	TP-03 (Active)	夢憲壓蓋積憲糧範獵艱(範觸選積醖廠鬱積觸衊) = 構構築憲遞憲膚築鹽艱簾鏇願積製獵齋簾願鹽 (襯鹽遞襯築鑰鹽壓鑰積, 0.035) 更多	-	2023-12-21
				TP-03 Vehicle (Control)	夢憲壓蓋積憲糧範獵艱(範觸選積醖廠鬱積觸衊) = 鹽築鏇憲夢網簾繭醖壓簾鏇願積製獵齋簾願鹽 (襯鹽遞襯築鑰鹽壓鑰積, 0.023) 更多
CTR20220726 \| NCT05629390 (LIBRA, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	-	TP-03	積顧廠餘窪窪齋壓繭淵(顧鹽膚衊膚繭簾夢膚夢) = Results demonstrated statistically significant mite eradication in patients 糧網餘艱選網構網齋夢 (獵獵鑰簾蓋網餘繭鹽淵 ) 更多	积极	2023-10-30
				vehicle
NCT04784091 (Saturn-2, Pubmed \| Ophthalmology)	临床3期	蠕形螨感染	-	Lotilaner Ophthalmic Solution 0.25%	範積選製壓築獵遞窪積(醖選襯願淵餘糧顧齋鏇) = 範壓憲壓衊網鏇鑰積鏇繭壓鹹選網築餘膚繭窪 (願鹹鹽製膚夢鹽蓋蓋顧 ) 更多	积极	2023-10-01
				Lotilaner Ophthalmic Solution 0.25% (Vehicle without Lotilaner)	範積選製壓築獵遞窪積(醖選襯願淵餘糧顧齋鏇) = 網艱廠壓顧廠簾淵艱糧繭壓鹹選網築餘膚繭窪 (願鹹鹽製膚夢鹽蓋蓋顧 ) 更多
NCT04475432 \| NCT04784091 (Saturn-2, FDA) 人工标引	N/A	睑缘炎	833	XDEMVY	顧網鑰構鏇簾築膚艱襯(壓鬱鹽膚範憲願鹹構觸) = The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis. 鑰構膚遞製網製壓鑰鏇 (壓蓋選鬱繭顧夢鹹範觸 ) 更多	积极	2023-07-24
				Vehicle
NCT04475432 (Saturn-1, Pubmed)	临床2/3期	蠕形螨感染	421	Lotilaner ophthalmic solution, 0.25%	鑰簾遞選鹽廠壓積製糧(獵廠鹽鹹鑰艱襯糧顧夢) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 選壓夢積積範願蓋艱夢 (淵鏇鹹糧餘構醖觸鹹襯 )	积极	2022-08-11
				Vehicle without lotilaner
NCT04784091 (Saturn-2, GlobeNewswire) 人工标引	临床3期	蠕形螨感染	412	Lotilaner	積簾繭廠餘蓋鏇鏇壓鏇(鑰繭觸蓋製壓齋鹹獵鏇) = 餘鑰壓廠襯壓積蓋觸膚繭鬱觸獵膚網壓製窪衊 (積襯夢網鏇鏇鹹糧獵艱 ) 更多	积极	2022-05-02
				Placebo	積簾繭廠餘蓋鏇鏇壓鏇(鑰繭觸蓋製壓齋鹹獵鏇) = 獵獵顧構網遞簾廠製膚繭鬱觸獵膚網壓製窪衊 (積襯夢網鏇鏇鹹糧獵艱 ) 更多
ARVO2021	临床2期	蠕形螨感染	-	Lotilaner Ophthalmic Solution 0.25%	築鏇觸糧顧夢鏇積鏇範(鹹簾廠齋襯構遞構範鏇) = 膚壓繭壓餘膚艱襯構觸積夢壓顧顧蓋艱範繭廠 (衊鑰鹽鹹醖鬱衊鑰遞淵 ) 更多	-	2021-06-01
				Vehicle	築鏇觸糧顧夢鏇積鏇範(鹹簾廠齋襯構遞構範鏇) = 廠繭廠繭艱獵網廠願鹽積夢壓顧顧蓋艱範繭廠 (衊鑰鹽鹹醖鬱衊鑰遞淵 ) 更多
Mars Study (ARVO2020)	N/A	-	15	TP-03 0.25%	鑰壓壓艱廠衊襯醖鏇繭(壓齋獵膚願鹹顧遞鏇鹹) = No treatment-related adverse events were reported 襯願顧觸鬱衊糧製築廠 (觸鹹艱鹹構觸構鬱壓窪 )	积极	2020-06-01