Tereo processed amniotic membrane (TPAM); A novel mainstream global therapy for moderate-to-severe dry eye disease

Tereo 处理羊膜 (TPAM)；

• 批准号: 10049121
• 金额: $ 89.17万
• 依托单位: NUVISION BIOTHERAPIES LIMITED
• 依托单位国家: 英国
• 项目类别: Investment Accelerator
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10049121
• 关键词: Tereo; processed; amniotic; membrane; TPAM

In a rapidly ageing global population, dry eye disease (DED) affects up to 50% of the global adult population, and 15-33% of people aged =65 years, with ~5.6m UK adults experiencing moderate-to-severe symptoms. DED is an incurable chronic age-related-condition that is a major cause of eye problems, frequent visits to eye-care practitioners, patient distress, and reduced patient quality-of-life, creating a significantly expanding global public health problem.The UK healthcare cost of managing DED by ophthalmologists is estimated at $1.10m/1,000 patients. In 2014, the NHS spent \>£27m distributing \>6.4m DED treatments which do not address the underlying disease. These over-the-counter lubricants/artificial tears remain the main option for patients providing only temporary comfort/symptomatic relief. Specialists-care prescription treatments such as cyclosporin are only available for unresponsive severe-DED and are associated with complications and poor long-term benefits.Amniotic membrane (amnion) is used in DED management but can only be recommended as a late-stage, last resort, treatment option because application traditionally requires surgery, reducing the number of patients that can benefit from amnion. Progress has been made in the US with surgery-free amnion products providing limited availability for 'in-office' use in severe-DED. However, routine use in DED is prevented by issues with traditional amnion-preparation methodologies compromising product benefits; reduced patient acceptance due to poor comfort/retention; high treatment costs; and a lack of published clinical data supporting amnion efficacy.Overcoming these issues, NuVision's unique Tereo(r) process delicately preserves amnion without compromising its natural healing potential, producing a room-temperature stable, point-of-care accessible, easy-to-use, and cost-effective treatment. Tereo processed amnion (TPAM-Omnigen(r)) can be applied in a surgery-free, 'in-office', setting using a bespoke bandage contact lens, allowing amnion to be used earlier in the DED-staged management process. Omnigen is already routinely used to treat ocular surface diseases in UK-hospitals, thus TPAM has the potential to also provide a transformative impact for DED.An ongoing investigator-led (Aston University) phase-IV randomised trial assessing the benefit of TPAM in moderate-to-severe DED is almost complete. Interim data is encouraging, but the study has highlighted the need for further research and development to improve patient acceptance and allow TPAM to become a widely accepted mainstream DED-treatment option.This project will provide the final and necessary research to refine the treatment/evidence for TPAM clinical efficacy through an enhanced phase-IV study. Output from the project will position TPAM as a mainstream treatment for the long-term management of both moderate- and severe-DED in a globally ageing population.

在快速增长的全球人口中，干眼病 (DED) 影响着全球高达 50% 的成年人口，以及 15-33% 65 岁以下人群，其中约 560 万英国成年人患有中度至重度症状。 DED 是一种无法治愈的与年龄相关的慢性疾病，是导致眼部问题、频繁去看眼科护理人员、患者痛苦以及患者生活质量下降的主要原因，从而造成了严重扩大的全球公共卫生问题。医疗费用眼科医生治疗 DED 的费用估计为 110 万美元/1,000 名患者。 2014 年，NHS 花费了 2700 万英镑分发了 640 万个 DED 治疗药物，但这些治疗方法并不能解决潜在的疾病。仅提供暂时安慰/症状缓解的患者的主要选择 专家护理治疗 处方治疗（例如环孢素）仅适用于。反应迟钝的严重 DED，并与并发症和长期获益不良相关。羊膜（amnion）用于 DED 治疗，但只能推荐作为晚期、最后的治疗选择，因为应用传统上需要手术，减少了美国在免手术羊膜产品方面取得了进展，为严重 DED 的“诊室”使用提供了有限的机会，但传统的 DED 问题阻碍了其常规使用。羊膜制备方法损害了产品的优点；由于舒适性/保留性差而降低了患者的接受度；以及缺乏支持羊膜功效的已发表的临床数据。自然愈合潜力，产生室温稳定、易于现场护理、易于使用且经济高效的经 Tereo 处理的羊膜治疗。 (TPAM-Omnigen(r)) 可以使用定制的绷带隐形眼镜在无需手术的“办公室”环境中应用，从而允许羊膜在 DED 阶段管理过程的早期使用 Omnigen 已经常规使用。在英国医院治疗眼表疾病，因此 TPAM 也有可能为 DED 带来变革性影响。一项正在进行的由研究者主导（阿斯顿大学）的 IV 期随机试验评估了 TPAM 的益处TPAM 治疗中度至重度 DED 的中期数据令人鼓舞，但该研究强调需要进一步研究和开发，以提高患者的接受度并使 TPAM 成为广泛接受的主流 DED 治疗选择。通过加强的 IV 期研究提供最终和必要的研究，以完善 TPAM 临床疗效的治疗/证据，该项目的成果将使 TPAM 成为中度和重度 DED 长期管理的主流治疗方法。一个全球人口老龄化。