Eye drops for all types of EB

The pain, scarring and loss of sight that can occur in several types of EB could be alleviated by the new eye drops being developed in this project.

Prof Liam Grover (left) at the University of Birmingham, UK, is collaborating with other specialists, including Prof Tony Metcalfe (right), to develop an eye drop for EB patients. A formulation that is blinked away more slowly would improve quality of life in terms of fewer applications per day and, in the future, make it viable to add expensive anti-scarring substances to an eye drop.

Read more in our researcher's blog.

I have EB simplex, (Dowling Meara) and have recently been diagnosed as having Blepharitis, which although isn’t painful, is uncomfortable despite my daily routine of applying a heat pad to my eyes, using drops and a special cleaning fluid.

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About our funding:

Research leader	Prof Liam Grover
Institution	University of Birmingham, UK
Type of EB	All types of EB with eye symptoms
Patient involvement	Advisory roles (PPI)
Funding amount	£144,569.00 (co-funded with DEBRA Ireland)
Project length	2 years
Start date	May 2023
DEBRA internal ID	GR000009

Latest progress summary:

Due 2024.

About our researchers:

Research leader:

Liam is a Professor of Biomaterials, appointed the youngest professor in the history of the University of Birmingham at the age of 32, and the Founder-Director of the Healthcare Technologies Institute at the University of Birmingham. He has established a strong track record of developing novel materials/technologies to the point of clinical application. This has resulted in a range of high impact works (including over 7000 citations from more than 150 papers; H-index of 45) and generated over 20 patents in the field. He has been involved in raising >£30m from the research councils (EPSRC, BBSRC, MRC, NC3Rs), the NIHR and charities (Wellcome), and currently sits on the DPFS and i4i panels, and on the EPSRC Strategic Advisory Team for Healthcare Technology. He will take responsibility for running of the project.

Co-researchers: Dr Richard Moakes is a lecturer in healthcare materials and GMP production manager in the Advanced Therapies Facility. Richard has a strong background in soft-materials and has worked extensively with the eye drop, having formulated, and manufactured it for clinical trial. Therefore, he will advise on the manufacturer and re-classification of the eye drop product.

Prof Anthony Metcalfe is Industrial Professor of Wound Healing at the University of Birmingham. He has over 25 years’ experience of developing and commercialising wound healing and scar reduction therapies taking these through to Phase III Clinical Trials. Throughout his career, translating novel therapies, he has developed a strong background in commercialisation and regulation. As such, he will provide advice and assistance in the translational pathway for the technology and its onward translation.

Prof Adrian Heagerty is a consultant dermatologist and honorary professor of dermatology within the University Hospitals NHS Trust in Birmingham. Adrian is the lead clinician for the Midlands and North of England, in the National epidermolysis bullosa Adult Service. He has been involved in the care and research into EB for 35 years. He will help to coordinate patient and public involvement, as he is currently in contact with ca. 320 patients with EB, and provide expertise surrounding the disease.

Ms Saaeha Rauz is a Reader in Translational Ophthalmology at the University of Birmingham and honorary consultant ophthalmologist specialising in ocular diseases such as severe dry eye. As part of her specialty, Saaeha is an expert in the areas of Pemphigoid, Stevens-Johnson Syndrome and Sjogren’s Syndrome all with very similar symptomatology and outcomes to EB. She is PI and Chief Investigator of the two first-in-human fluid gel Phase I clinical trials of the eye drop. She will therefore be valuable in understanding the ocular aspect of the programme.

Mr Amit Patel is a consultant ophthalmologist at University Hospitals NHS Trust. He provides routine eye care for the large cohort of adult patients with epidermolysis bullosa seen in the half national EB service, based in the Trust. He will therefore provide much of insight into patient eye care and routine monitoring.

Collaborator: Dr Holly Chinnery, University of Melbourne, Australia.

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Why this research is important:

The drops that are currently used tend to stay on the eye for short periods of time, meaning that they must be used over and over again throughout a day. In this project, we are trying to solve this problem by introducing a new eye drop that has been shown to stay on the surface of the eye for a much longer time. This will mean that patients need to apply their drops much less frequently. In the longer-term, these eye drop could be filled with molecules that can prevent scarring from occurring. We hope that this will provide patients with more freedom and a greater quality of life.

Prof Liam Grover

Researcher’s Abstract:

Grant Title: High-retention, lubricating eye drops to enhance quality of life in EB patients.

One of the side-effects of many types of EB is damage on the surface of the eyes, caused by scraping of the eyelid over an already sensitive eye. This can result in pain, scarring and potentially blindness. The damage caused by this process is a vicious cycle - damage to the eye reduces lubrication, which makes the eye more prone to damage.

At the moment, clinicians try to break the cycle by providing eye drops, which allow the eye lid to glide over the surface of the eye. The drops that are currently used tend to stay on the eye for short periods of time, meaning that they must be used over and over again throughout a day.

In this project, we are trying to solve this problem by introducing a new eye drop that has been shown to stay on the surface of the eye for a much longer time. This will mean that patients need to apply their drops much less frequently. In the longer-term, these eye drop could be filled with molecules that can prevent scarring from occurring. We hope that this will provide patients with more freedom and a greater quality of life.

The proposed work is of direct importance to patients with all forms of epidermolysis bullosa (EB) likely to develop dry eye symptomology, but particularly recessive dystrophic and junctional subtypes where blistering/ulceration of the ocular surfaces is most common.

This project will repurpose an eye-drop technology that is currently in the very late stages of development and make it ready for large-scale deployment to EB patients with ocular surface damage. This project will lever >£4m of research council investment (MRC and NIHR) that has enabled us to scale-up, manufacture, and collect toxicological data on the drop, to enable first-in-human trials. By the time the project starts, we will have completed first-in-human safety trials with healthy volunteers and will be moving towards treating patients with severe dry eye (NIHR) and microbial keratitis (MRC). For this reason, we feel that the work could have a major impact for patients within a period of two years.

To achieve this, the overarching aims of this project will be to:

With clinicians and patient groups, understand the requirements (in terms of disease) and needs of the final product, to provide a usable life-enhancing therapy.
Understand the underpinning science behind lubrication and rubbing between tissues within the ocular cavity to prevent blistering.
Characterise and compare the fluid gel eye drops to current treatment options in terms of both lubricity and retention.
Undertake the necessary steps to reclassify the eye drop from a medical product to medical device.

Researcher’s progress update: