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

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.