Public Funding for Nuvision Biotherapies Limited

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.

no public description

Amniotic membrane or amnion (the inner layer of the sac a baby grows in) has been used to treat wounds in eyes, skin and internal organs since the 1940s. NuVision(r) Biotherapies Ltd is a company spun out from the University of Nottingham Ophthalmology department to commercialise Omnigen(r). Expectant mothers who have planned caesarians can donate their amnion, which is then delicately dried (patented by NuVision), and cut by a manual process into Omnigen discs of variable sizes. Omnigen has been available since April 2016, and has been used to treat eye problems in 30 NHS hospitals including Moorfields Eye Hospital. It's easy to use and store, and has been applied to indications affecting the cornea. The volume of patients, means that we need to be able to automate accurate high volumes of 'units' to meet demand. To achieve this we need funding to investigate the technical challenges involved in this. In the USA, amnion is also routinely used in wound care, especially diabetic foot ulcers (DFU), leg ulcers and non-healing wounds. Dried amnion has been clinically proven to speed up healing times in these type of wounds. NuVision wants to meet the growing demand, and expand the ophthalmic and would care market in the UK and worldwide, to help preserve and save sight and also offer treatment for the 86,000 people in the UK living with DFU.

There are millions of corneal trauma cases globally each year. Without effective treatment, ocular surface trauma can progress to long term complication and corneal blindness. Amniotic membrane has been used in ophthalmic surgery to treat disease and damage to the surface of the eye. Unfortunately clinical usage of amnion has been severely limited as it is not readily available on demand at the hospital, especially in the treatment of an emergency eye injury case. NuVision has noted this restriction and devised OmnigenTM, an immediately accessible, dry amnion-derived product that will have a much greater utility and uptake, making amnion a realistic proposition for adoption by ophthalmic surgeons into emergency medicine