Co-development of a novel injection and crosslinking device for delivering long-acting biologic formulations for ocular drug delivery

共同开发一种新型注射和交联装置，用于提供用于眼部药物输送的长效生物制剂

• 批准号: 10027836
• 金额: $ 48.68万
• 依托单位: RE-VANA THERAPEUTICS LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10027836
• 关键词: Co; development; novel; injection; crosslinking

In the UK, every day more than 250 people start to lose their sight - creating a major health challenge to the NHS and global healthcare systems. The growth of new leaky blood vessels releasing fluid below or within the retina contributes to severe ocular diseases such as 'wet' age-related macular degeneration (AMD) and the complications of diabetes: diabetic retinopathy (DR) and diabetic macular edema (DME), in adults over 50-60 yrs old to 80 and beyond. For example, in the UK, nearly 400 individuals are diagnosed with AMD every day. Nearly 48% of UK adult AMD sufferers go blind due to the disease - which affects the central vision in the elderly making simple daily tasks such as reading, watching TV, car driving or recognising faces difficult. With increasing lifespan and the incidence of obesity, the prevalence of these diseases will continue to rise.Currently, ophthalmologists treat 'wet' AMD patients by direct ocular injection of expensive aqueous formulations of biologics. However, the need for monthly/bimonthly injections leads to poor patient compliance due to some adverse events effects such as bleeding in the eye, discomfort, redness, irritation and increase in intraocular pressure. A major compliance issue is the travel to and from the hospital, with 62% of patients requiring an escort to the ophthalmology clinic - leading to poor adherence. The rise in the number of AMD patients combined with the need for frequent injections puts pressure on an already over-stretched NHS still recovering from the impact of the Covid-19 pandemic. Surveys by the Macular Society, the Royal College of Ophthalmologists, and the Royal National Institute of Blind People, have shown that many clinics fail to meet recommended waiting times for AMD retreatment. Real-world data shows visual acuity deteriorates by 5-6 years despite promising clinical trials due to failed adherence.Re-Vana has developed OcuLief - a disruptive injectable biodegradable sustained-release formulation, crosslinked _in situ_ with a simple uv light pulsed device. The small volume implant will provide significant clinical benefits over current monthly intravitreal injections. Following injection into the eye, the implant would provide a continuous release for effective AMD treatment over a minimum of a 6 months and up to 12 months and potentially beyond. Therefore, the impact of this research will offer major benefits to a wide variety of users such as patients, scientists, clinicians, industry, and healthcare providers.

在英国，每天有超过250人开始失明，这对NHS和全球医疗保健系统构成了重大的健康挑战。在50-60岁以上至80岁及以上的成年人中，在视网膜下方或视网膜内释放流体的新渗漏血管的生长导致严重的眼部疾病，例如“湿性”年龄相关性黄斑变性（AMD）和糖尿病并发症：糖尿病视网膜病变（DR）和糖尿病黄斑水肿（DME）。例如，在英国，每天有近400人被诊断患有AMD。近48%的英国成年AMD患者因这种疾病而失明-这会影响老年人的中央视力，使简单的日常任务，如阅读，看电视，开车或识别面孔变得困难。目前，眼科医生通过直接眼部注射昂贵的生物制剂水溶液来治疗“湿性”AMD患者。然而，每月/每两个月注射一次的需要导致患者依从性差，这是由于一些不良事件影响，例如眼睛出血、不适、发红、刺激和眼内压升高。一个主要的合规性问题是往返医院的旅行，62%的患者需要护送到眼科诊所-导致依从性差。AMD患者数量的增加加上频繁注射的需求，给本已不堪重负的NHS带来了压力，该NHS仍在从新冠肺炎大流行的影响中恢复。黄斑协会、皇家眼科医师学院和皇家国家盲人研究所的调查显示，许多诊所未能满足AMD再治疗的推荐等待时间。真实世界的数据显示，尽管有希望的临床试验，但由于坚持失败，视力会下降5-6年。Re-Vana开发了OcuLief -一种破坏性的可注射生物降解缓释制剂，用简单的紫外光脉冲装置原位交联。小体积植入物将提供优于当前每月玻璃体内注射的显著临床益处。在注射到眼睛中之后，植入物将在最短6个月和最长12个月以及可能更长的时间内提供用于有效AMD治疗的连续释放。因此，这项研究的影响将为各种各样的用户提供重大利益，如患者，科学家，临床医生，行业和医疗保健提供者。