A Randomized Controlled, Double-Masked, Crossover Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration

To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration

开始日期2017-08-01

申办/合作机构

Allegro Ophthalmics LLC

NCT02435862

/ Completed临床2期

Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy

A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.

开始日期2015-02-01

申办/合作机构

Allegro Ophthalmics LLC

[+2]

NCT02348918

/ Completed临床2期

A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema

开始日期2014-10-13

申办/合作机构

Allegro Ophthalmics LLC

[+2]

100 项与 Risuteganib 相关的临床结果

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100 项与 Risuteganib 相关的转化医学

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100 项与 Risuteganib 相关的专利（医药）

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项与 Risuteganib 相关的文献（医药）

2024-03-01·Journal of ethnopharmacology

Anti-inflammatory effect and mechanism of active parts of Artemisia mongolica in LPS-induced Raw264.7 cells based on network pharmacology analysis.

Article

作者: Zhu, ZiWei ; Wang, Fangsheng ; Liu, Liu ; Aisa, Haji Akber ; Xin, Xuelei

ETHNOPHARMACOLOGICAL RELEVANCE:

Artemisia mongolica is well known for its use in folk medicine, it is commonly used to alleviate a variety of diseases associated with inflammation, such as laryngitis, tonsillitis, headaches and hepatitis in northwest China. However, its anti-inflammatory mechanism is still unknown.

AIM OF THE STUDY:

The most potential anti-inflammatory part (AMPA) was identified by screening individual parts of A. Mongolica. After the network pharmacological analysis, the anti-inflammation effects and molecular mechanisms of AMPA were evaluated in RAW264.7 cells induced by LPS.

MATERIALS AND METHODS:

AMPA was chosen as the most anti-inflammatory of the A. Mongolica, as measured by the effect of each part of the A. Mongolica on NO and COX-2. The chemical composition of AMPA was identified using HPLC-Q-TOF-MS/MS, and targets of bioactive chemicals and targets related to inflammation were found using open-source databases. The "Compound-targets" network and PPI network were established by combining compounds and overlapped targets, and targets in the PPI networks were analyzed by GO and KEGG enrichment. The RAW26.7 cells induced by LPS were used as a model of inflammation examination. MTT assay was performed to assess the cytotoxicity of AMPA on LPS-induced RAW264.7 cells. The level of NO was measured by the Griess method while the inflammatory factors were detected by ELISA. The protein expression levels of iNOS, COX-2, MAPK, NF-κB signaling pathway and AMPK/Nrf2-related proteins were determined by Western blot. The results of nuclear translocation of p65 and Nrf2 were analyzed by immunofluorescence assay.

RESULTS:

A total of 18 compounds with potential bioactivity were identified, and after intersecting 640 compound-predicted targets and 1608 inflammation targets, the compounds and intersected targets were utilized to structure "compound-target" and PPI networks. Among AMPA, AM6, AM7, AM11, AM8 and AM1 compounds were essential in the "compound-targets" network, meanwhile, TNF, RELA, MAPK1, NOS2, PRKAG, and PTGS2 targets play important roles in the PPI network. The top 10 terms and pathways were obtained based on GO and KEGG. The cell experiments show that 50 μg/mL was the maximum concentration of AMPA without cytotoxicity in the LPS-induced RAW264.7 cell model. When compared with the LPS group, AMPA treatment not only effectively suppressed the generation of NO, TNF-α, IL-6, PGE2, IL-1β and MCP-1 in LPS-induced RAW264.7 cells, but also down-regulated the expression of COX-2, iNOS and the protein levels p-ERK, p-p38, p-IκB-α and p-p65, inhibited the nuclear translocation of p65. Furthermore, the expression levels of p-LKB1, p-AMPK, Nrf2 and HO-1 proteins were up-regulated and Nrf2 nuclear translocation was promoted.

CONCLUSION:

AMPA should be considered an anti-inflammatory agent for the results of network pharmacology and in vitro, which could inhibit the MAPK pathway and NF-κB pathway and activate the AMPK/Nrf2 pathway in LPS-stimulated RAW264.7 cells.

2023-04-01·Acta pharmacologica Sinica

JP1, a polypeptide specifically targeting integrin αVβ3, ameliorates choroidal neovascularization and diabetic retinopathy in mice

Article

作者: Zhou, Jian-Wei ; Liu, Qing-Huai ; Xie, Zhan ; Wu, Xin-Jing ; Cui, Jia-Hua ; Yuan, Song-Tao ; Cheng, Rui-Wen

Anti-vascular endothelial growth factor (VEGF) drugs have revolutionized the treatment of neovascular eye diseases, but responses are incomplete in some patients. Recent evidence shows that integrins are involved in the pathogenesis of neovascular age-related macular degeneration and diabetic retinopathy. JP1, derived from an optimized seven-amino-acid fragment of JWA protein, is a polypeptide specifically targeting integrin αVβ3. In this study we evaluated the efficacy of JP1 on laser-induced choroidal neovascularization (CNV) and retinal vascular leakage. CNV mice received a single intravitreal (IVT) injection of JP1 (10, 20, 40 µg) or ranibizumab (RBZ, 10 µg). We showed that JP1 injection dose-dependently inhibited laser-induced CNV; the effect of RBZ was comparable to that of 20 µg JP1; a combined IVT injection of JP1 (20 μg) and RBZ (5 μg) exerted a synergistic effect on CNV. In the 3rd month after streptozotocin injection, diabetic mice receiving IVT injection of JP1 (40 µg) or RBZ (10 µg) once a week for 4 weeks showed significantly suppressed retinal vascular leakage. In both in vivo and in vitro experiments, JP1 counteracted oxidative stress and inflammation via inhibiting ROS/NF-κB signaling in microglial cells, and angiogenesis via modulating MEK1/2-SP1-integrin αVβ3 and TRIM25-SP1-MMP2 axes in vascular endothelial cells. In addition, intraperitoneal injection of JP1 (1, 5 or 10 mg) once every other day for 3 times also dose-dependently inhibited CNV. After intraperitoneal injection of FITC-labeled JP1 (FITC-JP1) or FITC in laser-induced CNV mice, the fluorescence intensity in the CNV lesion was markedly increased in FITC-JP1 group, compared with that in FITC group, confirming that JP1 could penetrate the blood-retinal barrier to target CNV lesion. We conclude that JP1 can be used to design novel CNV-targeting therapeutic agents that may replace current invasive intraocular injections.

2022-11-01·Ophthalmology. Retina

Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration

Article

作者: Jaffe, Glenn J ; Farsiu, Sina ; Srivastava, Sunil K ; Karageozian, Vicken ; Sarayba, Melvin ; Kaiser, Peter K ; Chiu, Stephanie J ; Abraham, Joseph R ; Loo, Jessica ; Ehlers, Justis P ; Bouckaert, Laurens

OBJECTIVE:

The purpose of the study was to perform a post hoc analysis to explore the effect of baseline anatomic characteristics identified on OCT on best-corrected visual acuity (BCVA) responses to risuteganib from the completed phase II study in subjects with dry age-related macular degeneration (AMD).

DESIGN:

Post hoc analysis of a randomized, double-masked, placebo-controlled, phase II study.

SUBJECTS:

Eyes with intermediate dry AMD with BCVA between 20/40 and 20/200. Patients with concurrent vision-influencing or macula-obscuring ocular pathologies were excluded.

METHODS:

Patients were randomized to receive a 1-mg intravitreal risuteganib injection or a sham injection at baseline. A second 1-mg intravitreal injection of risuteganib was given at week 16 to those in the treatment arm. Two independent, masked reading centers evaluated the baseline anatomic characteristics on OCT to explore features associated with positive responses to risuteganib.

MAIN OUTCOME MEASURES:

Treatment response was defined as a gain of ≥ 8 letters in BCVA from baseline to week 28 in the treatment arm, compared with baseline to week 12 in the sham group. Anatomic parameters, measured by retinal segmentation platforms, including measures of retinal thickness were compared between the responders and nonresponders to risuteganib.

RESULTS:

Thirty-nine patients completed the study and underwent analysis. In the treatment arm, 48% of eyes demonstrated treatment responses, compared with 7% in the sham group. In the quantitative anatomic assessment, enhanced ellipsoid integrity, greater outer retinal thickness, and decreased geographic atrophy were associated with increased BCVA gains to risuteganib.

CONCLUSIONS:

This post hoc analysis demonstrated that baseline OCT features may help determine the likelihood of a functional response to risuteganib. The characterization of higher-order OCT features may provide important information regarding biomarkers for treatment response and could facilitate optimized clinical trial enrollment and enrichment.

项与 Risuteganib 相关的新闻（医药）

2025-07-14

·今日头条

ESMO证实粪菌移植+免疫治疗双剑合璧，77%肺癌、75%黑色素瘤获益

2024年欧洲肿瘤内科学会（ESMO）大会上，公布了一项“应用粪便微生物移植（FMT）+免疫检查点抑制剂（ICI），联合治疗非小细胞肺癌（NSCLC）和黑色素瘤临床研究（NCT04951583）”的重磅数据！结果证实FMT可显著提高黑色素瘤患者对PD-1抑制剂的治疗活性。更具突破性的是，这是首次明确高剂量FMT（HDFMT）能够增强两种不同组织学类型肿瘤（NSCLC和黑色素瘤）中ICI的抗肿瘤活性。这一发现为肿瘤免疫治疗开辟了全新的联合策略，让微生物组与抗肿瘤免疫的协同潜力得到进一步验证，也为更多难治性肿瘤患者带来了优化治疗效果的新希望！ ▲截图源自“ESMO” 粪便微生物移植（FMT）联合免疫检查点抑制剂（ICI）显神威！非小细胞肺癌77%缓解、黑色素瘤75%缓解、另4例完全缓解为实体瘤治疗注入强心剂该研究（NCT04951583）共纳入40例患者，包括20例PD-L1≥50%的晚期非小细胞肺癌（NSCLC）患者（中位年龄为68岁，男性占55%）、20例晚期黑色素瘤患者（中位年龄56岁，男性占65%）。所有患者在ICI治疗前1周完成肠道准备（其中非小细胞肺癌组患者接受一线抗PD-1治疗、黑色素瘤组患者接受双重免疫检查点抑制剂治疗），随后口服健康供体（HD）的粪便微生物移植（FMT）胶囊，中位随访时间为7个月（IQR：3.2,12.6）。结果显示：非小细胞肺癌（NSCLC）队列前14名患者的客观缓解率（ORR）达77% ；黑色素瘤队列患者客观缓解率（ORR）为75% ，其中 4名患者达到完全缓解（CR）。 ▲图源“ESMO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除不止消化！肠道菌群化身抗癌“隐形盟友”：从饮食干预到FMT移植，三大硬核策略助癌症患者平衡菌群、增效抗癌、改善生活质量肠道菌群与人体构建起复杂而精密的共生网络，不仅深度参与宿主的代谢调控，更在免疫系统与神经系统的塑造中发挥关键作用。对于癌症患者而言，调节肠道菌群平衡已成为提升治疗效果、改善生活质量的重要策略。目前，主要可通过饮食干预、益生菌补充、抗生素治疗及粪便微生物组移植（FMT）四大途径实现肠道菌群的优化。 1、粪便微生物组移植（千年智慧的现代转化）：源自1700多年前中医理论的粪便微生物组移植（FMT），如今已成为前沿医学手段。该技术通过提取健康个体粪便中的菌群，制成菌液或胶囊，经内窥镜灌注、口服胶囊、结肠镜介入或灌肠等方式，将健康菌群移植至患者肠道，快速重建微生物多样性，用于治疗肠道内外疾病，为癌症患者提供了调节菌群的创新方案。 2、饮食干预（从源头调节菌群生态）：生命早期增加膳食纤维与益生元摄入、减少红肉食用并维持健康体重，可有效降低肿瘤发生风险。研究表明，饮食结构的调整能在24-48小时内显著改变肠道微生物组成。然而，癌症患者常因口腔黏膜炎、味觉改变及厌食症等副作用，导致饮食干预的实施面临挑战。 3、益生菌补充（激活肠道健康防线）：益生菌作为“活的非病原性微生物”，足量摄入可显著改善健康状况。部分益生菌菌株被证实能调节肠道菌群，增强癌症免疫治疗效果，减轻放化疗不良反应。临床研究显示，益生菌在结直肠癌、肝癌、肺癌等多种癌症治疗中，有助于提升预后，也获得跨国癌症支持治疗协会等权威指南的推荐，对预防结肠感染、重建肠道微生态平衡具有积极意义。 ▲图源“Front Immunol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语对于大多数肿瘤患者来说，调节肠道菌群有助于提升机体免疫功能、增强目前抗癌药物的疗效，同时，还有助于提高患者对传统治疗方法的敏感性，降低放化疗及手术治疗的副作用。目前，如何将粪菌移植、活性益生菌定制、补充益生元及调控饮食等治疗手段整合归一，真正实现个体化“精准”调控肠道菌群，从而提高免疫治疗及抗癌效果，是癌症治疗的新方向！小编也希望这种技术能尽快进入临床应用，让更多的癌症患者能受益于免疫疗法！如果您想了解粪便菌群移植或定制益生菌等的更多讯息，将治疗经历、近期影像及病理检查结果等，提交至全球肿瘤医生网医学部，初步评估营养状况。参考资料 [1]Elkrief A,et al.1068P Phase II trial of fecal microbiota transplantation (FMT) plus immune checkpoint inhibition (ICI) in advanced non-small cell lung cancer and cutaneous melanoma (FMT-LUMINate)[J]. Annals of Oncology, 2024, 35: S707-S708. https://www.annalsofoncology.org/article/S0923-7534(24)02645-0/fulltext 本文为全球肿瘤医生网原创，未经授权严禁转载

微生物疗法免疫疗法临床研究

2025-01-23

·PRNewswire

70+ Key Companies Advancing in Dry Age-Related Macular Degeneration Clinical Trial Therapeutic Space | DelveInsight

Dry macular degeneration is a common eye disorder among people aged above 50 years. It causes blurred or reduced central vision due to thinning of the macula. The macula is the part of the retina responsible for clear vision in a direct line of sight. The pharmaceutical industry is increasingly focused on developing pathway-based therapies for dry AMD, with promising treatments like ALK-001 and LBS-008 in trials, though a combination approach may be needed to fully inhibit disease progression. LAS VEGAS, Jan. 23, 2025 /PRNewswire/ -- DelveInsight's ' Dry Age-Related Macular Degeneration Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline dry AMD therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the dry AMD pipeline domain. Key Takeaways from the Dry Age-Related Macular Degeneration Pipeline Report DelveInsight's dry AMD pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for dry AMD treatment. Key dry AMD companies such as Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others are evaluating new dry AMD drugs to improve the treatment landscape. Promising dry AMD pipeline therapies such as ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others are under different phases of dry AMD clinical trials. In December 2024, Galimedix Therapeutics announced the initiation of its Phase II eDREAM study to assess the safety and efficacy of GAL-101 eye drops in patients with dry age-related macular degeneration. In December 2024, Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). In November 2024, Ocugen, Inc. announced positive preliminary efficacy and safety data from the Phase I dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings include: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and most importantly there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA). In October 2024, Eyestem Research, focused on creating scalable cell therapies for incurable diseases, had announced a positive outcome of the Drug Safety Monitoring Board (DSMB) review for the first cohort of its Phase one trial to treat Geographic Atrophy secondary to Dry Age-related Macular Degeneration, marking a milestone for Indian science and medical research. In September 2024, Stealth BioTherapeutics Inc. announced the presentation of new bevemipretide (SBT-272) preclinical data demonstrating topical ocular delivery to the retina with protective effects observed in models of AMD. In June 2024, Stealth BioTherapeutics Inc. announced that it has enrolled and dosed its first patient in the ReNEW trial as part of its Phase III clinical program for elamipretide in patients with dry age-related macular degeneration (dry AMD). The program consists of the two Phase III trials, ReNEW and ReGAIN. Both trials will evaluate the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide in participants with dry AMD. In April 2024, Eyestem received approval from India's Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE, a potential treatment for geographic atrophy arising from dry age-related macular degeneration (AMD). Request a sample and discover the recent advances in dry AMD treatment drugs @ Dry Age-Related Macular Degeneration Pipeline Report The dry AMD pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dry AMD drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dry AMD clinical trial landscape. Dry Age-Related Macular Degeneration Overview Age-related macular degeneration (AMD) is one of the top four causes of blindness in older adults and the leading cause of irreversible blindness in developed countries. Around 170 million people globally are affected by AMD, making it the third most common cause of vision loss worldwide. Dry AMD typically progresses slowly, but wet AMD can cause severe visual impairment within days or weeks of onset. In the early stages of AMD, there are no noticeable symptoms, though an ophthalmologist can detect drusen before symptoms arise. Some individuals experience slight vision changes during the intermediate stage, but many remain symptom-free. Others may notice dark or grey spots in their central vision or have difficulty transitioning from bright to dim lighting. Clinicians currently use various imaging techniques to monitor changes in the retina, retinal pigment epithelium (RPE), and choroid, including fundus exams, color fundus photography, fundus autofluorescence (FAF), optical coherence tomography (OCT), and infrared reflectance imaging. Over the past two decades, OCT has significantly advanced the early detection, monitoring, and treatment assessment of dry AMD. Modern spectral-domain OCT (SD-OCT) systems provide detailed cross-sectional and volumetric views of the retina, enabling clinicians to visualize, measure, and monitor retinal layers, RPE, hyperreflective foci, geographic atrophy (GA), and drusen. While SD-OCT remains the standard of care, emerging technologies like polarization-sensitive OCT (PS-OCT), which offers tissue-selective imaging, may revolutionize AMD research and clinical practices. Currently, no approved treatments exist for dry AMD. Management involves regular monitoring, timely detection of visual deterioration, appropriate rehabilitation, and early identification of choroidal neovascularization (CNV). Research is underway to explore therapeutic strategies to prevent AMD, slow its progression, or restore vision. Potential treatments include lifestyle and behavioral changes, age-related eye disease study (AREDS) supplements, visual cycle modulators, anti-inflammatory agents, complement inhibitors, gene therapy, cell-based therapies, and approaches to reduce toxic by-products. Find out more about dry AMD treatment drugs @ Drugs for Dry Age-Related Macular Degeneration Treatment A snapshot of the Dry Age-Related Macular Degeneration Pipeline Drugs mentioned in the report: Learn more about the emerging dry AMD pipeline therapies @ Dry Age-Related Macular Degeneration Clinical Trials Dry Age-Related Macular Degeneration Therapeutics Assessment The dry AMD pipeline report proffers an integral view of the dry AMD emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Dry Age-Related Macular Degeneration Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Dimerisation inhibitors, Vitamin A replacements, RBP4 protein inhibitors, Sigma-2 receptor antagonists, Complement factor H stimulants, Macrophage inhibitors, Cell replacements, RNA interference, Key Dry Age-Related Macular Degeneration Companies: Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others Key Dry Age-Related Macular Degeneration Pipeline Therapies: ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others. Dive deep into rich insights for new drugs for dry AMD treatment, visit @ Dry Age-Related Macular Degeneration Drugs Table of Contents For further information on the dry AMD pipeline therapeutics, reach out @ Dry Age-Related Macular Degeneration Treatment Drugs Related Reports Dry Age-Related Macular Degeneration Market Dry Age-Related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key dry AMD companies including Alkeus Pharmaceuticals, Belite Bio, Aviceda Therapeutics, Johnson & Johnson Innovative Medicine, Allegro Ophthalmics, Lineage Cell Therapeutics (CellCure Neurosciences), Roche, Cognition Therapeutics, Stealth BioTherapeutics, Evergreen Therapeutics, Annexon Biosciences, NGM Biopharmaceuticals, AstraZeneca, Alexion Pharmaceuticals, Ionis Pharmaceuticals, Novartis, Regenerative Patch Technologies, among others. Dry Age-related Macular Degeneration Epidemiology Forecast Dry Age-related Macular Degeneration Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted dry AMD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Age-related Macular Degeneration Market Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key AMD companies including Regeneron Pharmaceuticals, Novartis, Roche, Opthea Limited, Kodiak Sciences Inc., REGENXBIO, Alkahest Inc, Graybug Vision, Ribomic USA Inc, Outlook Therapeutics, Inc., Unity Biotechnology, Inc, PanOptica, Inc., Clearside Biomedical, Alexion Pharmaceuticals, AstraZeneca, Evergreen Therapeutics, Alkeus Pharmaceuticals, Stealth BioTherapeutics, CellCure Neurosciences, Regenerative Patch Technologies, Allegro Ophthalmics, Annexon Biosciences, NGM Biopharmaceuticals, Ionis Pharmaceuticals, Apellis Pharmaceuticals, Iveric Bio, Gyroscope Therapeutics, Luxa Biotechnology, Gemini Therapeutics , among others. Wet Age-related Macular Degeneration Market Wet Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Wet Age-related Macular Degeneration companies including EyePoint Pharmaceuticals, Inc., AbbVie, Caregen Co. Ltd., Exegenesis Bio, Shanghai Henlius Biotech, Skyline Therapeutics, 4D Molecular Therapeutics, Ocugenix Corporation, Adverum Biotechnologies, Inc., Ashvattha Therapeutics, Inc., AiViva BioPharma, Inc., Ocular Therapeutix, Inc., Clearside Biomedical, Inc., Hoffmann-La Roche, Kyowa Kirin, Inc., Opthea Limited, AffaMed Therapeutics Limited, EyeBiotech Ltd., Novartis , 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] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床3期临床2期

2024-02-20

·Pharmaceutical Technology

Singapore HSA accepts AffaMed’s NDA for ocular treatment

DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye. Credit: 4 PM production/Shutterstock.com. The Singapore Health Sciences Authority (HSA) has accepted the new drug application (NDA) for AffaMed Therapeutics’ DEXTENZA (0.4 mg dexamethasone ophthalmic insert) to treat ocular inflammation and pain. The treatment is indicated following ophthalmic surgical procedures and for ocular itching linked to allergic conjunctivitis. This marks a significant milestone for the company as it seeks to expand the reach of DEXTENZA, which is already approved in the US and listed in Macau for similar indications. DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye. It offers dexamethasone to the ocular surface for up to 30 days without the use of preservatives. See Also: US FDA accepts review of argenx’s VYVGART Hytrulo for CIDP Iovance’s Amtagvi for melanoma treatment gains FDA approval The insert’s unique feature is its reabsorption, enabling it to exit the nasolacrimal system on its own. AffaMed is progressing the development of DEXTENZA as the first physician-administered, sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China. The convenience of a single administration that delivers a preservative-free dose of dexamethasone over 30 days provides significant benefits over existing therapies, which typically require multiple daily eye-drop applications. The company has also initiated a registrational trial to assess the efficacy and safety of DEXTENZA against a placebo vehicle for treating inflammation and pain post-cataract surgery in mainland China. Topline data from this trial is anticipated in the third quarter of 2024. AffaMed entered a licensing agreement with Ocular Therapeutix in October 2020 in a strategic move to broaden its market. The agreement covers the development and commercialisation of DEXTENZA in South Korea, Greater China and some ASEAN [Association of South East Asian Nations] markets. AffaMed CEO Vijay Karwal stated: “As the first NDA filing by AffaMed, the acceptance of our DEXTENZA NDA in Singapore represents an important milestone in our company’s journey to successfully advance much-needed therapeutic candidates through regulatory pathways across multiple regions in Asia. “DEXTENZA is the lead candidate in AffaMed’s innovative and differentiated ophthalmology pipeline and represents an important advancement in the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.” In September 2023, the company received approval from China’s National Medical Products Administration for a clinical trial application of risuteganib (Luminate ) to treat intermediate dry age-related macular degeneration.

引进/卖出申请上市上市批准

100 项与 Risuteganib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11436	-	-	DB14911

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
干性年龄相关性黄斑病变	临床3期	-	Hanmi Pharmaceutical Co., Ltd.	2022-01-30
湿性黄斑变性	临床2期	美国	Allegro Ophthalmics LLC	2017-08-01
非增殖性糖尿病视网膜病变	临床2期	美国	Allegro Ophthalmics LLC	2015-02-01
外周血管疾病	临床2期	美国	Allegro Ophthalmics LLC	2015-02-01
糖尿病性黄斑水肿	临床2期	美国	Allegro Ophthalmics LLC	2014-10-13
玻璃体黄斑粘连	临床2期	美国	Allegro Ophthalmics LLC	2014-02-01
湿性年龄相关性黄斑变性	临床2期	墨西哥	Allegro Ophthalmics LLC	2012-03-01
视网膜色素变性	临床1期	韩国	Hanmi Pharmaceutical Co., Ltd.	2018-12-31

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临床结果

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分期

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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


NCT03626636 (Pubmed) 人工标引	临床2期	年龄相关性黄斑变性	39	risuteganib	鏇鑰顧廠憲製鏇衊襯鹽(淵憲鑰鑰膚網築襯夢壓) = 構齋窪窪獵繭獵襯襯窪鏇構繭壓衊範築網鹽鹹 (簾繭選鹽餘衊願鹽窪壓 ) 更多	积极	2022-08-01
				sham injection	鏇鑰顧廠憲製鏇衊襯鹽(淵憲鑰鑰膚網築襯夢壓) = 夢鹽遞醖鹹鹹壓鏇淵願鏇構繭壓衊範築網鹽鹹 (簾繭選鹽餘衊願鹽窪壓 ) 更多
ARVO2022	临床2期	黄斑成群色素沉着	-	Risuteganib	蓋夢壓膚糧膚餘遞廠製(淵糧艱網構醖鏇願鏇廠) = 醖淵餘選製獵網廠鬱襯壓淵製鹹膚鹽獵壓選遞 (餘繭齋艱鹽夢簾淵製繭 )	-	2022-05-01
NCT03626636 (Pubmed \| Ophthalmic Surg Lasers Imaging Retina) 人工标引	临床2期	年龄相关性黄斑变性	45	risuteganib	觸製選淵鏇鏇繭憲獵繭(蓋憲鑰艱鑰襯蓋餘窪齋) = 憲醖糧鹹築構遞衊顧餘顧願繭鑰選醖襯鏇餘衊 (鬱遞遞衊醖齋鑰艱膚簾 ) 更多	积极	2021-06-01
				sham injection	觸製選淵鏇鏇繭憲獵繭(蓋憲鑰艱鑰襯蓋餘窪齋) = 壓網糧淵壓鹹夢鏇蓋艱顧願繭鑰選醖襯鏇餘衊 (鬱遞遞衊醖齋鑰艱膚簾 ) 更多
AAO2020	临床2期	年龄相关性黄斑变性	-	Risuteganib 1.0mg	壓艱鏇齋鑰憲憲襯齋艱(製繭願鹽壓淵積鑰糧膚) = 鏇獵衊繭繭醖範鏇衊網獵範鬱鏇蓋艱壓憲餘淵 (窪窪獵鏇艱膚繭顧鏇憲 )	-	2020-11-13
				Risuteganib	壓艱鏇齋鑰憲憲襯齋艱(製繭願鹽壓淵積鑰糧膚) = 製積夢簾積衊顧窪範淵獵範鬱鏇蓋艱壓憲餘淵 (窪窪獵鏇艱膚繭顧鏇憲 )
ARVO2020	临床2期	湿性年龄相关性黄斑变性	-	Risuteganib 1.0mg	遞網鑰夢簾積鬱願憲網(顧簾蓋蓋構鹹願糧範積) = 範衊憲鏇顧艱製網鹽網醖鏇蓋齋艱遞鑰艱鏇積 (夢憲積壓醖醖選壓廠襯 ) 更多	积极	2020-06-01
				Risuteganib (Sham)	遞網鑰夢簾積鬱願憲網(顧簾蓋蓋構鹹願糧範積) = 壓淵鏇窪觸構醖衊觸醖醖鏇蓋齋艱遞鑰艱鏇積 (夢憲積壓醖醖選壓廠襯 )
NCT02348918 (CTgov)	临床2期	糖尿病性黄斑水肿	218	Luminate 1.0mg (Luminate 1.0mg Group)	壓獵夢範糧窪醖襯獵齋(蓋繭糧範製願餘蓋鬱壓) = 鑰築憲鬱夢網願襯網築觸憲廠鹽鹹艱窪壓糧選 (觸鹹蓋壓齋艱夢窪鬱夢, 3) 更多	-	2018-12-07
				Luminate 2.0mg (Luminate 2.0mg Group)	壓獵夢範糧窪醖襯獵齋(蓋繭糧範製願餘蓋鬱壓) = 遞構遞願繭夢顧糧遞餘觸憲廠鹽鹹艱窪壓糧選 (觸鹹蓋壓齋艱夢窪鬱夢, 3) 更多
PO489 (AAO2018)	临床2期	糖尿病性黄斑水肿	80	1.25-mg bevacizumab (BEV)	繭獵齋簾廠廠醖鹽製簾(簾鬱糧餘顧築獵淵膚艱) = 顧淵鏇鹹蓋淵夢鹹製夢鏇廠衊築鏇遞衊繭糧壓 (窪積積簾衊衊淵淵觸廠 )	积极	2018-10-29
				ALG 1.0-mg	繭獵齋簾廠廠醖鹽製簾(簾鬱糧餘顧築獵淵膚艱) = 夢網鏇鹹鬱簾積餘鬱淵鏇廠衊築鏇遞衊繭糧壓 (窪積積簾衊衊淵淵觸廠 )
ARVO2018	临床2期	糖尿病性黄斑水肿一线 \| 二线	80	1.25mg bevacizumab	衊壓襯窪齋窪鏇糧鬱夢(襯觸醖選襯夢襯鹹願襯) = 蓋鹽鏇繭範鬱壓鹹襯膚獵艱顧醖鬱壓願製蓋廠 (夢衊繭觸構簾遞鏇鏇窪 )	积极	2018-07-01
				ALG-1001 1.0mg	衊壓襯窪齋窪鏇糧鬱夢(襯觸醖選襯夢襯鹹願襯) = 醖範製鏇鹹蓋襯糧構選獵艱顧醖鬱壓願製蓋廠 (夢衊繭觸構簾遞鏇鏇窪 )
PA010 (AAO2017)	临床2期	糖尿病性黄斑水肿	136	ALG-1001 1.0 mg	願壓繭蓋繭艱積築遞餘(鏇願艱齋糧鬱繭糧淵製) = 餘網艱觸餘範糧蓋觸鏇艱簾鹽製糧蓋衊範顧餘 (膚齋餘鹹艱鑰積廠襯襯 )	积极	2017-11-12
				bevacizumab 1.25 mg	願壓繭蓋繭艱積築遞餘(鏇願艱齋糧鬱繭糧淵製) = 網糧築繭遞繭鏇夢鑰襯艱簾鹽製糧蓋衊範顧餘 (膚齋餘鹹艱鑰積廠襯襯 )