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

在全球人口迅速老龄化的背景下，干眼病（DED）影响了全球多达50%的成年人和15-33%的65岁人群，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，是眼部问题、频繁就医、患者痛苦和患者生活质量下降的主要原因，造成了一个显著扩大的全球公共卫生问题。英国眼科医生治疗DED的医疗费用估计为110万美元/ 1000名患者。2014年，英国国家医疗服务体系（NHS）花费2700万英镑，分发了640万份没有针对潜在疾病的DED治疗方案。这些非处方润滑剂/人工泪液仍然是患者的主要选择，只能提供暂时的舒适/症状缓解。专家护理处方治疗，如环孢素，仅适用于无反应的严重ded，并且与并发症和不良的长期效益有关。羊膜（amnion）用于DED的治疗，但只能作为晚期的最后手段，因为传统的应用需要手术，减少了从羊膜中获益的患者数量。在美国，无手术羊膜产品已经取得了进展，为严重ded患者提供了有限的“室内”使用。然而，由于传统羊膜制备方法影响产品效益的问题，在DED中的常规使用受到阻碍；由于舒适度/滞留性差，患者接受度降低；治疗费用高；而且缺乏支持羊膜功效的公开临床数据。NuVision独特的Tereo(r)工艺克服了这些问题，在不影响羊膜自然愈合潜力的情况下，巧妙地保存了羊膜，产生了室温稳定、即时护理、易于使用且具有成本效益的治疗方法。Tereo处理羊膜（TPAM-Omnigen(r)）可以使用定制的绷带隐形眼镜在免手术的“办公室”环境中使用，允许羊膜在ed阶段的管理过程中更早使用。Omnigen已经在英国医院常规用于治疗眼表疾病，因此TPAM也有可能对DED产生变革性影响。一项正在进行的由阿斯顿大学（Aston University）领导的评估TPAM对中重度DED益处的iv期随机试验即将完成。中期数据令人鼓舞，但该研究强调了进一步研究和开发的必要性，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。该项目将提供最终和必要的研究，通过加强第四期研究来完善TPAM临床疗效的治疗/证据。该项目的产出将使TPAM成为全球老龄化人口中中度和重度ded长期管理的主流治疗方法。

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.