A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome

The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.

开始日期2019-12-20

申办/合作机构

Mitotech SA

[+1]

NCT03764735

/ Completed临床3期

A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

开始日期2018-12-06

申办/合作机构

Mitotech SA

[+1]

NCT02121301

/ Completed临床2期

Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

开始日期2014-04-01

申办/合作机构

Mitotech SA

[+1]

100 项与 Plastoquinonyl decyl triphenylphosphonium 相关的临床结果

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100 项与 Plastoquinonyl decyl triphenylphosphonium 相关的转化医学

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100 项与 Plastoquinonyl decyl triphenylphosphonium 相关的专利（医药）

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250

项与 Plastoquinonyl decyl triphenylphosphonium 相关的文献（医药）

2025-07-01·BIOCHIMIE

Divergent ferroptotic pathways in breast cancer cells: IGFBP6-regulated mitochondrial lipid peroxidation under erastin and omega-3 DHA treatment

Article

作者: Nikulin, Sergey ; Razumovskaya, Alexandra ; Fatkulin, Artem ; Averinskaya, Darya ; Kolodeeva, Oksana ; Silkina, Mariia ; Kolodeeva, Olga ; Tonevitsky, Alexander ; Kulagin, Timur ; Olkhovik, Darya ; Klycheva, Karina

Breast cancer remains a major challenge and new therapeutic approaches are needed for its treatment. Ferroptosis is considered a promising alternative cell death mechanism to eliminate resistant cancer cells. In previous works, we identified that lower IGFBP6 gene expression in tumor tissue corresponds to a worse prognosis for breast cancer patients and, at the same, time makes them more sensitive to ferroptosis. In this study, we further investigated the mechanism of ferroptosis induction in IGFBP6 knockdown and control MDA-MB-231 breast cancer cells by the canonical ferroptosis inducer erastin and omega-3 docosahexaenoic acid (DHA). Our results indicate that there is a significant overlap between the mechanisms of action of both of these molecules, as they regulate the same subset of genes, and their action can be inhibited by canonical ferroptosis inhibitors. On the other hand, we also observed significant differences between the effects of erastin and DHA. The most notable of these are the additional activation of apoptosis-related genes by DHA and its minor peroxidation of mitochondrial lipid membranes. Interestingly, our kinetic analysis of ferroptosis induction showed that IGFBP6 knockdown cells began to die earlier and could hardly be rescued from erastin-induced ferroptosis by mitochondrial antioxidant SkQ1, in contrast to control cells. Overall, our data suggest that the action of DHA is less dependent on mitochondrial membrane peroxidation during ferroptosis induction, and this molecule can be a promising candidate for the treatment of breast cancer, especially in the case of reduced IGFBP6 gene expression in cancer cells.

2025-05-01·METABOLISM-CLINICAL AND EXPERIMENTAL

Ceramides increase mitochondrial permeabilization to trigger mtDNA-dependent inflammation in astrocytes during brain ischemia

Article

作者: Pan, An ; Qi, Lian-Wen ; Huang, Feng-Qing ; Wang, Hong-Fei ; Liu, Shi-Jia ; Alolga, Raphael N ; Liu, Peian ; Ma, Gaoxiang ; Yang, Tong ; Liu, Baolin ; Yang, Dai

The brain is rich in lipids, and disorders or abnormalities in lipid metabolism can induce neurotoxicity. Ceramides are the central intermediates of sphingolipid metabolism. This study was designed to investigate the potential lipotoxicity of ceramides in brain ischemia. First, a pseudo-targeted lipidomics analysis of plasma samples from stroke patients found significantly elevated levels of long-chain ceramides. A similar observation was made in mice subjected to permanent middle cerebral artery occlusion (pMCAO) surgery. In cultured cells, it was found that the altered ceramides were mainly derived from astrocytes via de novo pathway, and SPTLC2 was a key regulator because Sptlc2 knockdown largely blocked ceramide production. Ceramides induced astrocyte activation and triggered oxidative stress to impair mitochondrial homeostasis by increasing mitochondrial permeabilization. Moreover, ceramides triggered the formation of voltage-dependent anion channel (VDAC) oligomers in the mitochondrial outer membrane, through which mtDNA was released into the cytoplasm. Similar to oxygen and glucose depletion treatment, ceramides also increased cGAS activity and STING protein expression. However, this activity was diminished in the presence of the mitochondrial ROS scavenger SKQ1, indicating the involvement of oxidative stress in ceramide action. By facilitating cGAS/STING signaling cascades, ceramides resultantly induced interferon response to aggravate inflammatory damage in the ischemic brain. To address the impact of ceramides on brain ischemic injury in vivo, ceramide generation was blocked in the brain by injection of AAV9-Sptlc2 shRNA in pMCAO mice. Sptlc2 knockdown in the brain reduced ceramide generation and attenuated brain ischemic damage with astrocyte inactivation. As expected, Sptlc2 deficiency effectively blocked cGAS/STING pathway-dependent interferon responses. Together, these findings suggest a new therapeutic strategy for pharmacological intervention to attenuate neuroinflammation.

2025-03-17·Current Molecular Pharmacology

The Mitochondrial Targeting Drug SkQ1 Attenuates the Progression of Post- Traumatic Osteoarthritis through Suppression of Mitochondrial Oxidative Stress

Article

作者: Wang, Peng-Cheng ; Zhi, Zhen-Ya

Background::

Post-traumatic osteoarthritis (PTOA) constitutes a distinct subtype of osteoarthritis (OA). Despite extensive research, no effective pharmacological intervention has been established to prevent or halt the progression of PTOA. Current therapeutic approaches are primarily limited to symptomatic management and pain relief. SkQ1, a novel mitochondria-targeted antioxidant, has emerged as a promising therapeutic agent due to its dual capacity to scavenge excessive intracellular reactive oxygen species (ROS) and modulate inflammatory responses.

Objective::

This study aimed to investigate the therapeutic potential of SkQ1 in the early stages of PTOA and elucidate its underlying molecular mechanisms.

Methods::

Chondrocytes were cultured under varying concentrations of SkQ1 to evaluate its cytotoxicity. Additionally, an in vitro oxidative stress model was established to assess the antioxidant effects of SkQ1 across different concentration levels, from which the optimal concentration for PTOA treatment was determined. The rat PTOA model was established through medial meniscal tear (MMT) surgery, followed by intra-articular administration of SkQ1 postoperatively. The gait characteristics of rats in each group were assessed biweekly following surgery. Outcome measures were evaluated at 2 and 6 weeks postoperatively, including pathological evaluation of knee cartilage, ROS levels, markers of oxidative damage, such as malondialdehyde (MDA) and 8-hydroxy-deoxyguanosine (8-OHdG), mitochondrial membrane potential, mitochondrial DNA copy number, and apoptosis-related cytokines.

Results::

In vitro, lower concentrations of SkQ1 (500 nM) exhibited superior antioxidant efficacy while minimizing cytotoxicity. The results indicated that SkQ1 administration significantly enhanced knee joint functionality and mitigated articular cartilage degeneration in both the acute and subacute phases of PTOA by inhibiting oxidative stress pathways. In a rat model of PTOA, SkQ1 not only alleviated gait abnormalities, but also substantially reduced levels of oxidative stress biomarkers, including ROS, MDA, and 8-OHdG. Furthermore, SkQ1 effectively preserved mitochondrial membrane potential and increased mitochondrial DNA copy number. Mechanistically, SkQ1 inhibited the release of cytochrome C (Cyt-C) and apoptosis-inducing factor (AIF) and downregulated key components of the mitochondria-mediated apoptotic pathway, such as Bax, Bak, cleaved caspase-3, and cleaved caspase-9.

Conclusion::

The findings suggested that SkQ1 exerts its therapeutic effects via multiple mechanisms, including the reduction of ROS accumulation, mitigation of oxidative damage, preservation of mitochondrial function, and inhibition of apoptotic pathways. These diverse actions position SkQ1 as a promising disease-modifying agent for PTOA treatment, potentially offering benefits that extend beyond those provided by current symptomfocused therapies.

项与 Plastoquinonyl decyl triphenylphosphonium 相关的新闻（医药）

2023-09-13

·CPHI制药在线

仿制药 | 干眼药物立他司特首仿报产

关注并星标CPHI制药在线 9月11日，成都康弘药业集团股份有限公司3类仿制药「立他司特滴眼液」的上市申请获CDE受理。立他司特（Lifitegrast）是一种新型小分子整合素抑制剂，通过抑制淋巴细胞功能相关抗原1（LFA-1）与细胞间粘附分子1的结合，从而减少由T淋巴细胞介导的炎症水平。 2016年7月，原研立他司特滴眼液被FDA批准用于治疗干眼症症状和体征，商品名为Xiidra。作为首个且唯一一个专门针对干眼症症状和体征的非类固醇滴眼液，Xiidra市场表现不错，2021年、2022年全球销售额分别为4.68亿美元和4.87亿美元。值得一提的是，Xiidra几经易手。该药最初由SARcode Bioscience开发，2013年Shire通过收购SARcode Bioscience将其纳入囊中。2018年武田收购Shire获得Xiidra，2019年武田将Xiidra相关权益卖个诺华。今年7月，诺华（Novartis）又将Xiidra卖给眼部健康专家博士伦（Bausch+Lomb)。据悉，Xiidra化合物专利于2024年11月15日到期，适应症专利于2026年5月17日到期。目前，Xiidra还未在国内获批，但康弘药业、齐鲁制药、贝特制药、辰欣药业四家企业已开始布局Xiidra仿制药市场。其中康弘药业率先递交立他司特滴眼液3类仿制药上市申请，预计有望取得该品种首仿生产批件。除了Xiidra，维眸生物也研发了一款治疗干眼症的LFA-1拮抗剂，即VVN001。该药新一代LFA-1拮抗剂，可高效阻断LFA-1与配体ICAM-1的结合，有效控制眼部炎症反应，缓解干眼症状。在美国开展的2期临床试验结果显示：在完成84天治疗期后，主要疗效终点指标--下方角膜荧光染色较基线的改善表面VVN001具有良好的治疗效果，5%治疗组的改善明显高于对照组。干眼治疗新进展据2020年《中国干眼专家共识定义和分类》，干眼是多因素引起的慢性眼表疾病，是由泪液的质、量及动力学异常导致的泪膜不稳定或眼表微环境失衡，可伴有眼表炎症、组织损伤及神经异常，造成眼部多种不适症状和/或视功能障碍。干眼是全球最常见的眼表疾病。受生活方式改变、电子产品广泛使用等影响，干眼发病率不断攀升，据悉其全球发病率大约5.5%-33.7%，我国干眼发病率约为21%-30%。治疗方面，干眼治疗包括物理治疗、修复治疗、抗炎治疗。物理治疗包括热敷、睑板腺按摩、清洁眼睑等，通过促进睑板腺通畅，减轻眼睛局部炎症，增强泪液稳定性。以人工泪液（玻璃酸钠滴眼液）为代表的修复治疗多用于干眼轻症患者，是目前国内对于干眼最常用的给药方案。抗炎治疗主要针对中重度干眼患者，代表药物如糖皮质激素、免疫抑制剂环孢素、非甾体抗炎药。干眼药物市场规模巨大，据悉2020年全球干眼产品销售额约为52.4亿美元，预测2023-2024年干眼产品销售额将达峰值，约为58.0亿美元。具体品种上，环孢素眼用制剂是销售额最高的一款干眼产品，2020年销售额高达24.2亿美元。鉴于干眼巨大的市场体量，越来越多的药企开始涉足该领域，且取得不错进展。据不完全统计，近年来全球监管机构批准了多款新活性成分干眼药物，如Xiidra、Eysuvis、Tyrvaya（varenicline，伐尼克兰溶液）鼻喷雾剂、Miebo。 Eysuvis（0.25％氯替泼诺混悬型滴眼液）是FDA批准的唯一一款皮质醇类干眼药物，其利用Kala Pharmaceuticals的Ampplify黏液穿透颗粒（MPP）给药技术，以增强皮质类激素在眼表的渗透性，用于短期（长达两周）治疗干眼的体征和症状。 Tyrvaya鼻喷雾剂是一种高选择性胆碱能激动剂，通过激活三叉神经副交感神经通路，从而增加基础泪膜的生成，2021年10月被FDA批准用于治疗干眼症（DED）的症状和体征。 Miebo是一款首创、无水、非甾体、单组分不含防腐剂的滴眼液，活性成分全氟己基辛烷是一种半氟烷烃，可防止泪液过度蒸发并具有恢复泪膜平衡的能力。2023年5月，该药被FDA批准用于治疗干眼的症状，成为FDA批准的首个，且唯一一个直接针对干眼泪液蒸发的药物。此外，目前全球还有多款干眼新药处于后期临床，如Reproxalap、RGN-259、AR-15512、SkQ1、PL-9643、Tivanisiran。其中Reproxalap是一款潜在首创小分子活性醛化物质（RASP）抑制剂，通过降低RASP水平，达到抑制炎症、缓解症状的作用。今年2月，该药治疗干眼的新药申请获FDA受理。 RGN-259是一种新型治疗性肽（胸腺素β4），具有保护组织以及促进修复及再生的特性，拟用于治疗中重度干眼。 AR-15512是一款瞬时受体电位TRPM8激动剂。TRPM8受体是位于角膜神经末梢的冷热感受器离子通道，AR-15512通过激活角膜中的冷热感受器，增加泪液的产生和眨眼速度，恢复泪膜的稳定性，减少眼部不适。 SKQ1是一种小分子心磷脂过氧化抑制剂，通过向线粒体提供抗氧化剂质体醌，靶向活性氧发挥作用。 PL-9643是一款黑素皮质素受体（MCR）激动剂，研究显示其可显著减少角膜上皮损伤，具有与Restasis（环孢菌素滴眼液）相似的效果。 Tivanisiran是一种基于RNA干扰的药物，能够将TRPV1基因沉默，降低TRPV1的表达，从而治疗干眼症。已公布研究结果显示，Tivanisiran能够明显减轻眼部不适及疼痛，改善干眼患者的结膜充血状态，且安全性良好。总结眼科是医药领域药物研发的黄金赛道，干眼作为常见的眼科疾病，更是国内外药企争相布局的热门领域。随着干眼发病率的上升，干眼药物市场需求也不断增加。虽然全球已获批多款干眼新药，但干眼市场仍有待进一步挖掘。希望企业的付出不会白费，更加高效、安全的干眼新药早日获批上市。智药研习社近期课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

并购专利到期临床结果

2023-06-25

·CPHI制药在线

市场 | 中国眼科药物市场将达千亿，创新是出口

关注并星标CPHI制药在线作者：马瑞当前，大众爱眼护眼意识的加强，对于白内障、青光眼、干眼病、眼部炎症等眼部疾病的忠实不断提高。眼科用药的市场开始呈现空间广阔、潜力大等特点，是公认的黄金赛道。1外资抢占7成市场份额2016年至2020年，全球眼科药物市场规模从277亿美元增长至350亿美元，预计2025年将达到425亿美元，2030年将达到734亿美元。2016-2020年，中国眼科药物市场规模从151亿元增长至188亿元，复合年增长率为5.7%；预计2025年将达到440亿元，2030年将达到1166亿元。2015-2030年全球及中国眼科医药市场来源：Frost&Sullivan从全球到全国，可以看出，眼科药物市场正在快速增长，空间巨大。不过由于技术壁垒高、新药研发难度大，想要站稳脚跟、甚至在市场拔得头筹，对于国内药企来说，并非易事。据悉，眼科药物市场的不断扩大，与全球老龄化趋势、电子产品泛滥、用眼常识缺乏等关系密切。从市场布局来看，诺华、罗氏、拜耳、艾尔建（艾伯维旗下）、爱尔康、日本参天制药、基因泰克、再生元等外资企业，及恒瑞医药、兴齐眼药、兆科眼科、极目生物和欧康维视等本土企业已纷纷入局。从市场份额来看，外资企业依然占据中国大部分市场，份额达60%-70%。其中，诺华、日本参天和爱尔康三家占近一半市场。康弘药业、兴齐眼药等本土眼科企业也不断在眼科抗感染药、环孢素滴眼液等产品上进行开拓，争取一席之地。诺华和美国爱尔康主要眼科产品为妥布霉素滴眼液、妥布霉素地塞米松滴眼液/眼膏等；相比之下，日本参天制药在中国处方药市场的表现尤为出色，其生产的可乐必妥和爱丽分别是目前国内销售额较高的眼科抗感染药物和干眼症治疗药物。2022年，爱尔康在国内上市了散光矫正型三焦点人工晶状体（AcrySofIQ PanOptixToric），这也是目前国内首个通过美国FDA首次批准的三焦点散光矫正型晶状体。上市不到四个月，PanOptixToric植入手术已达200例；同时在诊断领域推出里程碑式的产品——LuxOR Revalia Ophthalmic Microscope 眼科显微镜，将会成为爱尔康在中国上市的首款眼科显微镜产品；此外还针对干眼症患者推出了治疗睑板腺功能障碍的Systane iLux MGD 治疗系统等。今年4月11日，罗氏眼科双抗法瑞西单抗（faricimab）新适应症在华申报上市。根据罗氏公司2022年的财报，法瑞西单抗的年销售额为5.91亿瑞士法郎（按照去年平均汇率计算约为6.19亿美元）。这种出色的销售表现与其卓越的疗效密不可分。此前，阿柏西普（2mg）、雷珠单抗、布西珠单抗等治疗方法最多只能将wAMD患者的用药频率维持在每3个月一次，而法瑞西单抗可以将注射频率降低至每4个月一次。此外，再生元/拜耳公司已经开发了阿柏西普的新规格（8mg），同样可以将注射频率降低至每4个月一次。2干眼症、过敏性结膜炎仍受关注在我国，眼部疾病主要有眼部炎症、青光眼、白内障、视疲劳、近视眼和干眼症等。其中，治疗角膜/沙眼病的药物、改善视疲劳的药物以及治疗白内障的药物市场需求较大。据相关统计，在2021年，我国角膜/沙眼病用药市场规模72.06亿元，占比35.05%；改善视疲劳药物规模56.48亿元，占比27.47%；白内障用药市场规模18.30亿元，占比8.90%。而2021年国内中重度干眼症市场规模接近12亿元，未来五年平均增速将达到30%以上。此外，目前我国干眼症患者约有3.6亿，患病率在20%左右，而治疗率仅为10%。来源：智研咨询，制图：贝壳社从产品剂型来看，2022年我国滴眼剂市场规模为138.45亿元，口服用药市场规模为26.66亿元，注射剂型市场规模为19.21亿元，其他剂型市场规模为28.88亿元。来源：智研咨询，制图：贝壳社事实上，干眼症已成为我国患者最多的眼科疾病。据统计，2019年的干眼症患者已超过2亿1千万人，并且还在以2%的年复合增速增长，预计到2030年，将有超过2亿6千万人。鉴于干眼症的市场潜力，近几年，本土企业在干眼症领域布局较多，亿胜生物、远大医药、恒瑞医药、和铂医药、康哲药业、维眸生物、欧康维视、未名生物、熙健医药等企业均有布局，有望成为新蓝海。此外过敏性结膜炎也备受关注。目前，本土药企通过仿制、自主研发或合作的方式深入干眼症市场，投入颇大，部分企业营收初见成效。玻璃酸钠眼用制剂是医院市场销售规模最大的干眼症眼药水，市场占比超25%，透明质酸眼用制剂占比25.85%，重组牛碱性成纤维细胞生长因子眼用制剂占比25.58%。其中，国内玻璃酸钠滴眼液市场的大部分份额仍被国外企业德国悟兹法姆药业和参天制药包揽，份额超8成，其余份额则由珠海联邦、齐鲁制药、浙江尖峰药业等企业分享。透明质酸眼用制剂市场则由Abott、LG Life Sciences、华熙生物、昊海生物和协合医疗等国内外企业占据。不过，近两年玻璃酸钠和透明质酸在医院呈现下滑态势，而重组牛碱性成纤维细胞生长因子眼用制剂则呈上升趋势。据悉，重组牛碱性成纤维细胞生长因子眼用制剂是由珠海亿胜生物独家生产的的干眼症眼药水，近年来在我国院内的销售额均超6亿元，2021年同比增长35.93%，达到8.84亿元，2022年全年销售额将近10亿元。此外，亿胜生物科技在2018年与Mitotech公司合作，获得其干眼症在研新药SkQ1滴眼液于新加坡及大中华地区的独家永久商业化许可权利，此后还获得眼科领域与该药相关的发明及专利所有权。至2022年12月31日，亿胜生物科技用于SkQ1临床开发的实际投资成本合计约3.54亿元。远大医药在今年4月公布用于治疗干眼症的小分子多肽药物GPN00136(BRM421)的II期临床试验申请已获得国家药监局(NMPA)临床试验默示许可。远大医药还推出了全球创新的小分子多肽滴眼液GPN00153，能够在两周内缓解干眼症症状和体征。该药品在国内的IND申请已于今年1月获得受理，目前正在海外进行III期临床研究。今年2月，恒瑞医药SHR8058滴眼液（又称NOV03）上市申请获药监局受理，用于治疗睑板腺功能障碍相关干眼症。据悉，该药是恒瑞医药从Novaliq公司引进的CyclASol（0.1%环孢菌素A制剂），是一种创新眼药水疗法。截至目前，恒瑞医药在该干眼症眼药水相关项目上累计投入研发费用约7851万元。今年3月，其子公司成都盛迪医药SHR8028滴眼液的上市许可申请获得国家药监局受理。据悉该药品是从Novaliq GmbH公司引进的CyclASol（1%环孢菌素A制剂），属于抗炎和免疫调节剂，用于干眼症的治疗。截至目前，SHR8028滴眼液相关项目累计已投入研发费用约8433万元。全福生物科技近日宣布，其治疗干眼症的新药BRM421自2022年12月启动第三期人体临床试验以来，已成功在美国完成了第一位患者的收案，为美国多中心、双盲、随机、制剂对照（vehicle-controlled）的三期临床试验，将招募700多名中重度干眼症患者。预计该试验将于2023年第四季度完成。今年4月份，远大医药获得了全福生技授予开发及商业化该产品的权利。兴齐眼药的三类仿制药0.05%环孢素滴眼液（Ⅱ）（商品名“兹润”）在2020年获批上市，预计该药在中国的市场规模大约为18亿元。兆科眼科开发的干眼症创新药——环孢素A眼凝胶的上市申请于2022年6月获国家药监局受理。该药今年1月陆续通过国家药监局的药品注册及临床试验现场核查，并通过广东省药品监督管理局的GMP符合性检查，向着最终注册及商业化迈进。该药如果上市，将是兴齐眼药的强势竞争对手。此外，和铂医药授权引进的特那西普滴眼液（HBM9036，环孢素）也已经进展到三期临床。除了干眼症，过敏性结膜炎药物研发同样备受关注。据Reseach and Markets相关市场研究预测，全球结膜炎治疗市场有望在2021年至2028年期间增长约11亿美元，复合年增长率约5.4%。今年1月，日本参天公司的创新药环孢素滴眼液（Ⅲ）被纳入国家医保目录，该药用于治疗4岁及以上儿童和青少年的严重性春季角/结膜炎。4月，欧康维视称其引进Nicox公司的具有抗敏特性的强效及高选择性组胺H-1受体拮抗剂OT-1001（Zerviate）（用于治疗过敏性结膜炎相关的眼痒）的新药上市申请已获得国家药监局受理。创新药方面，益承生物于2021年披露的其自主研发治疗过敏性结膜炎、已完成二期临床研究的化学1类新药——广谱抗炎创新药伊匹乌肽滴眼液随后再未披露临床研究新进展，背后原因不得而知。3创新才是出口药物治疗作为眼科疾病的基础治疗手段，眼科药物技术的迭代与发展对于全民眼健康的整体水平提升具有重要意义，创新型的、具备更优疗效的眼科药物的出现将填补部分空白适应症领域，并为眼病患者带来更为丰富的药物选择。目前，国内眼科药企的主流管线仍以仿制药、改良型新药为主，药物研发主要集中在开发已获批药物的改良工艺和剂型上，少有关注新靶点或新的作用机制，使得产品同质化相对严重。国内研发基础相对薄弱、资本市场认知有限、患者疾病治疗意识薄弱、前沿领域法规不明晰等都是掣肘国内眼科药物发展的因素。本土企业想要实现突破还需要一定时间。亦有专业人士表示，眼科疾病的治疗机制尚未完全明确，因此开发针对性的创新疗法仍然面临重大挑战。为了帮助患者改善症状甚至获得治愈，该领域不仅需要更多全新的分子机制或具有变革性的创新疗法，还需要新的递送手段来优化现有产品的疗效和安全性。参考资料：1.《眼科用药市场将破170亿！康弘抢攻、齐鲁搅局，恒瑞首仿不断，昔日神药止跌》，米内网，2022-06-08.2.《30亿干眼症眼药水市场！玻璃酸钠市场最大，多款新药值得关注》，药融云，2023-02-03.3.《罗氏first in class眼科双抗新适应症在华申报上市》，医药魔方，2023-04-11.4.《诺华出售眼科资产加速战略调整：注重发展优先治疗领域》，药时代，2023-03-22.5.《医药行业专题报告：眼科用药空间广阔，近视、干眼症赛道值得关注》，东方证券，2022-06-16.6.《四月46款1类新药获批临床，多款为首次在国内获批》，人民日报健康客户端，2023-04-30 . 来源：贝壳社声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

财报上市批准医药出海

2023-05-23

·PRNewswire

DelveInsight Evaluates a Robust Dry Eye Disease Clinical Trial Pipeline as 60+ Influential Pharma Players to Set Foot in the Domain

The prevalence of dry eye disease has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of dry eye disease and the growing research and development activities to develop novel therapies to treat dry eye disease to drive the market. The companies developing the potential therapies in the last stage of development include Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, and several others. LAS VEGAS, May 23, 2023 /PRNewswire/ -- DelveInsight's ' Dry Eye Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline dry eye disease therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, and the future growth potential of the dry eye disease pipeline domain. Key Takeaways from the Dry Eye Disease Pipeline Report DelveInsight's dry eye disease pipeline report depicts a robust space with 50+ active players working to develop 60+ pipeline therapies for dry eye disease treatment. Key dry eye disease companies such as TearSolutions, Novaliq, HanAll Biopharma, Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, BRIM Biotechnology Inc., Dompé Farmaceutici S.p.A, Okyo Pharma Ltd, AxeroVision, Inc., Palatin Technologies, Seikagaku Corporation, Invirsa, Inc., Allysta Pharmaceutical, Taejoon Pharmaceutical Co., Ltd., Ocular Therapeutix, Inc., Dreamhawk Vision Biotech, Inc., Yuyu Pharma, Inc., Novartis Pharmaceuticals, VivaVision Biotech, Inc, Huons Co., Ltd., and others are evaluating new dry eye disease drugs to improve the treatment landscape. Promising dry eye disease pipeline therapies in various stages of development include Reproxalap, Timbetasin, Visomitin, HL036, CyclASol, Lacripep, AR15512, AZR MD 001, ST-100, SURF-100, SURF-200, GLK-301, BRM421, Oxervate, OK-101, AXR 159, AXR 270, PL9643, SI-614, INV-102, ALY688, TJO-083, OTX-CSI, OTX-DED, SHJ002, YP-P10, ECF843, VVN001, HU007 and others. In March 2023, Selagine, Inc., a spin-out company from the University of Illinois at Chicago (UIC), announced that it has entered into a research, development, and sublicense agreement with Grifols (Nasdaq: GRFS), a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for dry eye disease.Under the agreement, Selagine will receive an upfront payment and annual collaboration fee. In addition, Grifols has committed to fund the development of immunoglobulin eye drops through FDA approval, which will be managed collaboratively by Grifols and Selagine, including the clinical, manufacturing and regulatory activities required for FDA approval for dry eye disease indication. In February 2023, Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of November 23, 2023. The FDA noted that no potential filing review issues have been identified, and that an advisory committee meeting is not currently planned. In February 2023, Novaliq, announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) determined that CyclASol® is eligible to be reviewed in a centralized procedure to receive a Union Marketing Authorisation for the European Economic Area (EEA). In January 2023, Bausch + Lomb Corporation and Novaliq GmbH, announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).In the study, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AEs) (9.6% NOV03 group, 7.5% control group) or treatment-related ocular AEs (6.3% NOV03 group, 3.1% control group). In August 2022, Alcon and Aerie Pharmaceuticals, Inc. announced the companies have entered into a definitive merger agreement through which Alcon acquired Aerie. The transaction affirmed Alcon's commitment to the ophthalmic pharmaceutical space and is expected to add broader pharmaceutical R&D capabilities to Alcon's existing commercial expertise, maximizing the value of its diversified portfolio. Through the transaction, Alcon added the commercial products Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% and Rhopressa® (netarsudil ophthalmic solution) 0.02%, as well as AR-15512, a Phase 3 product candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical product candidates. In May 2022, Yuyu Pharmaceutical presented a poster study for YP-P10, its new dry eye syndrome treatment, during the 2022 ARVO (Association for Research in Vision and Ophthalmology) conference. YP-P10 is a new biopharmaceutical using synthetic peptides, aiming to relieve signs and symptoms of dry eye syndrome caused by inflammation by administering the treatment twice a day. According to preclinical trial results unveiled at the conference, Yuyu confirmed that the candidate had an excellent anti-inflammatory mechanism and corneal epithelial cell healing effect compared to existing drugs. Request a sample and discover the recent advances in dry eye disease drug treatment @ Dry Eye Disease Pipeline Report The dry eye disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dry eye disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dry eye disease clinical trial landscape. Dry Eye Disease Overview Dry eye disease is characterized as a multifactorial disease of the tears and ocular surface that causes symptoms such as pain, visual disruption, and tear film instability, as well as potential ocular surface damage. It is accompanied by increased tear osmolarity and transient ocular surface irritation. When tear production and drainage are out of balance, dry eyes can result. People with dry eyes either do not produce enough tears or have poor-quality tears. Dry eyes can occur for various reasons, including age, gender, drugs, and medical disorders. Dry eye disease symptoms include redness, stinging, itching, or burning sensations, light sensitivity, watery eyes, stringy mucus near the eye, and blurred vision. A thorough eye examination can detect dry eyes. Dry eye disease treatments seek to restore or maintain the usual number of tears in the eye in order to reduce dryness and associated discomfort and to maintain eye health. The basic approaches used to manage and treat dry eyes include adding tears with over-the-counter artificial tear solutions, conserving tears, boosting tear production, and treating the inflammation of the eyelids or eye surface that contributes to dry eyes. Find out more about drugs for dry eye disease @ New Dry Eye Disease Drugs A snapshot of the Dry Eye Disease Pipeline Drugs mentioned in the report: Learn more about the emerging dry eye disease pipeline therapies @ Dry Eye Disease Clinical Trials Dry Eye Disease Therapeutics Assessment The dry eye disease pipeline report proffers an integral view of dry eye disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Dry Eye Disease Pipeline Report Coverage: Global Dry Eye Disease Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Dry Eye Disease Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Dry Eye Disease Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Dry Eye Disease Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Dry Eye Disease Therapeutics Assessment By Mechanism of Action: Malondialdehyde inhibitors, Actin modulators, Amyloid inhibitors, Angiogenesis inducing agents, Apoptosis inhibitors, Cell movement activators, Collagen stimulants, Heat-shock protein modulators, MicroRNA modulators, Nerve growth factor stimulants, NF-kappa B inhibitors, Stem cell stimulants, Antioxidants, Electron transport chain complex protein modulators, Lipid modulators, Tumour necrosis factor alpha inhibitors, Eye protein modulators, TRPM8 protein stimulants, Glucocorticoid receptor agonists, Inosine monophosphate dehydrogenase inhibitors, Muscarinic receptor agonists Key Dry Eye Disease Companies: TearSolutions, Novaliq, HanAll Biopharma, Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, BRIM Biotechnology Inc., Dompé Farmaceutici S.p.A, Okyo Pharma Ltd, AxeroVision, Inc., Palatin Technologies, Seikagaku Corporation, Invirsa, Inc., Allysta Pharmaceutical, Taejoon Pharmaceutical Co., Ltd., Ocular Therapeutix, Inc., Dreamhawk Vision Biotech, Inc., Yuyu Pharma, Inc., Novartis Pharmaceuticals, VivaVision Biotech, Inc, Huons Co., Ltd., and others. Key Dry Eye Disease Pipeline Therapies: Reproxalap, Timbetasin, Visomitin, HL036, CyclASol, Lacripep, AR15512, AZR MD 001, ST-100, SURF-100, SURF-200, GLK-301, BRM421, Oxervate, OK-101, AXR 159, AXR 270, PL9643, SI-614, INV-102, ALY688, TJO-083, OTX-CSI, OTX-DED, SHJ002, YP-P10, ECF843, VVN001, HU007, and others. Dive deep into rich insights for new drugs for dry eye disease treatment; visit @ Dry Eye Disease Medications Table of Contents For further information on the dry eye disease pipeline therapeutics, reach out @ Dry Eye Disease Drug Treatment Related Reports Dry Eye Disease Market Dry Eye Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dry eye disease companies, including Oyster Point Pharma, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, among others. Dry Eye Disease Epidemiology Forecast Dry Eye Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and dry eye disease epidemiology trends. Mild Dry Eye Market Mild Dry Eye Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key mild dry eye companies, including Allergan Plc., Novartis AG., Otsuka Pharmaceutical Co. Ltd., Santen Pharmaceutical Co. Ltd., among others. Moderate Dry Eye Market Moderate Dry Eye Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key moderate dry eye companies, including Santen Pharmaceutical Co. Ltd., OASIS Medical, Alcon Inc., Bausch Health Companies Inc., AbbVie Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床3期临床结果并购

100 项与 Plastoquinonyl decyl triphenylphosphonium 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	-	S02AA	-

研发状态

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适应症	国家/地区	公司	日期
干眼症	俄罗斯	-	2012-07-01

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适应症	最高研发状态	国家/地区	公司	日期
干眼综合征	临床3期	美国	Mitotech SA	2018-10-27
Leber氏遗传性视神经萎缩	临床2期	俄罗斯	Mitotech LLC	2018-12-31
失衡综合征	临床2期	美国	Mitotech SA	2014-04-01
干燥综合征性角膜结膜炎	临床2期	美国	Mitotech SA	2014-04-01
青光眼	临床1期	美国	Mitotech SA	2022-01-30
黄斑变性	临床1期	美国	Mitotech LLC	2018-12-07
葡萄膜炎	临床1期	美国	Mitotech LLC	2018-11-16
结核	临床前	中国	华中农业大学	2023-12-14
急性肾损伤	临床前	美国	Mitotech LLC	2018-11-20
Barth综合征	临床前	美国	Mitotech LLC	-

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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


ARVO2022	N/A	Leber氏遗传性视神经萎缩 mitochondrial optic neuropathy \| LHON-related mutations in mtDNA	43	Visomitin (SkQ1 ophthalmic solution)	簾夢衊壓鏇蓋鹹膚蓋獵(鏇繭窪餘範憲醖鹹範製) = 觸衊鏇鏇觸艱築積鹽壓簾獵衊鏇願願獵獵襯構 (構鹹選範範齋獵觸獵簾 )	积极	2022-05-01
NCT03764735 (VISTA-1, CTgov)	临床3期	干眼综合征	452	SkQ1 (Vehicle) (SkQ1 Vehicle)	淵齋遞餘膚窪夢獵艱鹹(構積鹹製範觸積餘築製) = 鬱窪淵繭繭範鬱製淵鏇鹹廠醖鬱範餘網構網積 (壓願繭簾鹽齋襯構遞艱, 0.773) 更多	-	2022-01-19
				Low Dose - SkQ1 (Low Dose - SkQ1)	淵齋遞餘膚窪夢獵艱鹹(構積鹹製範觸積餘築製) = 衊鹽簾醖窪顧積網糧壓鹹廠醖鬱範餘網構網積 (壓願繭簾鹽齋襯構遞艱, 0.816) 更多
NCT04206020 (VISTA-2, CTgov)	临床3期	干眼综合征	610	SkQ1 Vehicle Solution	繭遞繭壓鬱襯選餘憲製(選膚衊淵遞鹹餘淵鏇獵) = 窪鹹鹹鏇壓廠願廠壓糧範繭顧餘膚鏇窪製憲簾 (壓壓顧鏇簾鬱壓構構醖, 1.36) 更多	-	2022-01-19
NCT04206020 (VISTA-2, NEWS) 人工标引	临床3期	干眼综合征	610	SkQ1	齋積網觸範蓋網願積網(鏇構網積夢餘齋觸夢鬱) = Showed a statistically significant clearance of central fluorescein staining 廠膚積鬱膚蓋衊餘範構 (網艱鑰蓋獵糧範選築鏇 ) 更多	积极	2021-02-24
				Vehicle
NCT02121301 (CTgov)	临床2期	干燥综合征性角膜结膜炎 \| 失衡综合征	91	Low Dose 0.155µg/mL SkQ1 ophthalmic solution (Low Dose SkQ1)	顧觸糧廠壓夢糧網選壓(餘選醖齋蓋壓醖艱觸獵) = 廠窪鹽網構繭膚衊選範餘鹹鹽鏇選鑰膚製繭網 (糧襯廠衊築構簾簾鑰範, 0.675) 更多	-	2020-10-14
				High Dose 1.55µg/mL SkQ1 ophthalmic solution (High Dose SkQ1)	顧觸糧廠壓夢糧網選壓(餘選醖齋蓋壓醖艱觸獵) = 鏇鹽築觸窪窪窪窪簾衊餘鹹鹽鏇選鑰膚製繭網 (糧襯廠衊築構簾簾鑰範, 0.704) 更多