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

在迅速老龄化的全球人口中，干眼病(DED)影响着高达50%的全球成年人口，15%-33%的65岁人口，约560万英国成年人出现中到重度症状。DED是一种无法治愈的与年龄相关的慢性疾病，是导致眼睛问题、频繁就诊眼科医生、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。英国眼科医生管理DED的医疗成本估计为每1000名患者110万美元。2014年，NHS花费了2700万英镑分发不能解决潜在疾病的640万种DED疗法。这些非处方药润滑剂/人工泪液仍然是患者仅提供暂时舒适/症状缓解的主要选择。专家护理处方疗法，如环孢菌素，仅适用于无反应的重度DED，并与并发症和较差的长期利益相关。羊膜(羊膜)用于DED的治疗，但只能被推荐为晚期，最后的治疗方案，因为应用传统上需要手术，减少了可以从羊膜中受益的患者数量。在美国，免手术羊膜产品已经取得了进展，为重度DED提供了有限的办公室内使用。然而，DED的常规使用受到以下问题的阻碍：传统的羊膜制备方法损害了产品的好处；由于舒适性/保持性差而降低了患者的接受度；治疗成本较高；以及缺乏已公布的支持羊膜疗效的临床数据。克服了这些问题，NuVision独特的Tereo(R)过程在不影响其自然愈合潜力的情况下微妙地保存了羊膜，产生了一种室温稳定、可获得护理点、易于使用和具有成本效益的治疗方法。Tereo Proceded羊膜(TPAM-Omnigen(R))可以应用于使用定制绷带隐形眼镜的无需手术的“办公室”环境中，使羊膜可以在DED分期管理过程中更早地使用。在英国的医院中，Omnigen已经被常规用于治疗眼表疾病，因此TPAM也有可能为DED提供变革性的影响。正在进行的由研究人员领导(阿斯顿大学)的第四阶段随机试验评估TPAM在中到重度DED中的益处，该试验即将完成。中期数据令人鼓舞，但这项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成为被广泛接受的主流DED治疗方案。该项目将提供最终和必要的研究，通过增强的IV期研究来完善TPAM临床疗效的治疗/证据。该项目的成果将使TPAM成为在全球老龄化人口中长期管理中度和重度DED的主流疗法。

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.