Keratoconus patients with dangerously thin corneas could soon avoid painful transplant surgery with a single eyedrop that stiffens the eye's surface without using UV light. The condition, which warps the cornea and blurs vision, affects 1 in 2000 people in the UK and costs the NHS roughly £5 million annually in cross-linking procedures. Current treatment requires removing the protective corneal layer, applying a photosensitiser, then blasting the eye with UVA radiation—a process that damages cells, causes significant discomfort, and cannot be used on the 10–20% of patients whose corneas are too thin. Those patients instead face corneal transplants, 750 to 1000 each year in the UK at £4335 per patient. The University of Liverpool team has developed a chemical cross-linker that stiffens the cornea when applied under local anaesthetic through a suction ring, without removing the epithelium or using UV light. If this programme—which includes drug characterisation, preclinical safety testing, and a health economics plan—succeeds in supporting a clinical trials application, the treatment could shift keratoconus care from hospital-only procedures to primary care settings, saving the NHS an estimated £4.5 million annually while offering a pain-free option for patients currently ineligible for standard cross-linking.
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Our primary objective is to develop a treatment that is substantially better than the current standard of care for patients with keratoconus. Keratoconus is a progressive condition in which the cornea becomes misshapen leading to vision loss. It has an incidence of 1 in 2000 in the UK, increasing to 1 in 200 in south Asia, and generally occurs in patients between 12 and 40 years of age having a major impact on their education and work. We estimate that sight loss and blindness due to keratoconus cost the UK over £400m in 2022. We have developed a medicinal product that can be administered to the eye to stiffen the cornea as a treatment for keratoconus. The proposed research builds on our current formulation to progress the translation of the technology to a clinical setting. The University of Liverpool has already filed a patent application; WO2023237898A1. The current treatment involves cross-linking of the cornea by administration of a photosensitiser and activation by UVA irradiation, which is toxic to corneal cells and may result in long term damage. There is also a need to remove the corneal epithelium in most cases to facilitate diffusion of the photosensitiser throughout the stroma causing considerable discomfort for the patient and a risk of infection. Currently cross-linking treatment is restricted by the corneal thickness. Those with a thin cornea (10-20%) often require corneal transplants instead, accounting for 750 to 1000 corneal transplants annually in the UK at an estimated cost of £4335 per patient. Our corneal cross-linker is easier to use by the clinician and more comfortable for the patient while causing similar stiffening and could be applied to those patients with thinner corneas. Through previous MRC DPFS funding we have shown that our formulation is well tolerated in vivo and that no changes were observed histologically in the corneal or surrounding tissues. It can be administered to the cornea under local anaesthetic, without removing the epithelium, as a pain-free, simple solution within a suction ring. We believe it has the potential to change the patient care pathway as it is appropriate for administration in primary care settings in contrast to current cross-linking treatments that require hospital facilities. The primary end users will be the clinicians caring for patients with keratoconus. An estimated 2000 cross-linking procedures take place every year in the UK, each costing £2483 meaning the NHS spends approximately £5m annually on treating keratoconus in this manner. We estimate the market value of our solution to be £250/treatment saving the NHS £4.5m annually excluding those that would otherwise have a transplant. Patients with other ectatic diseases could significantly increase the patient population that could benefit from our treatment and those requiring prophylactic cross-linking for refractive surgery may benefit in the longer term. This programme aims to provide a comprehensive evaluation of our drug formulation to support a clinical trials application (CTA) and a health economics feasibility plan for future translation. This project will produce drug substance characterisation and preclinical safety packages based on appropriate regulatory advice, required for CTA submission. This work is critical to increase the value proposition and attract funders/investors. It will derisk the technology to support progress towards partnership with a company who will develop the technology as a commercial product including the development of the delivery system and marketing.
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