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

在快速老龄化的全球人口中，干眼症（DED）影响高达50%的全球成年人口，15 - 33%的年龄≥ 65岁的人群，约560万英国成年人出现中度至重度症状。DED是一种无法治愈的慢性年龄相关疾病，是导致眼部问题、频繁就诊于眼科医生、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。据估计，英国眼科医生管理DED的医疗费用为110万美元/1,000名患者。2014年，NHS花费了2700万英镑分发了640万DED治疗药物，但这些药物并没有解决潜在的疾病。这些非处方润滑剂/人工泪液仍然是患者的主要选择，仅提供暂时的舒适/症状缓解。环孢菌素等专科医生处方治疗仅适用于无反应的重度DED，并与并发症和长期效益差相关。羊膜（羊膜）用于DED管理，但只能推荐作为晚期最后手段的治疗选择，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，免手术羊膜产品已取得进展，为重度DED患者提供了有限的“办公室”使用。然而，常规使用DED是由传统的药物制备方法的问题，损害产品的好处，降低患者的接受度，由于不良的舒适性/保留，高治疗成本，克服这些问题，NuVision独特的Tereo（r）工艺微妙地保存了羊膜，而不损害其自然愈合潜力，产生室温稳定，即时可用、易于使用且具有成本效益的治疗。Tereo处理的羊水（TPAM-Omnigen（r））可以使用定制的绷带隐形透镜在无需手术的“办公室”环境中应用，从而可以在DED阶段的管理过程中更早地使用羊水。Omnigen已经在英国医院常规用于治疗眼表疾病，因此TPAM也有可能为DED提供变革性的影响。一项正在进行的评估TPAM在中度至重度DED中获益的IV期随机试验（阿斯顿大学）即将完成。中期数据令人鼓舞，但该研究强调需要进一步的研究和开发，以提高患者的接受程度，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，以通过增强的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.