A new fluid-gel dressing, applied as eye drops, forms a protective film over the cornea that lasts for hours instead of minutes. This matters because ocular surface disease—a chronic condition that causes severe dry eye and pain comparable to angina—affects millions globally. Current treatments, from lubricating drops to contact lenses, either wear off quickly or are difficult to tolerate. The gel, called FLG-1001, is designed to be resorbable, meaning the body breaks it down naturally, and can also deliver therapeutic substances like donor serum. If the research succeeds, patients with moderate to severe disease could apply the gel once and go about daily activities—reading, driving, working—without constant re-dosing. For some, that could mean returning to work or independent living. The project also builds a scalable manufacturing process within NHS Blood and Transplant, the UK’s sole cost-price supplier of serum drops, which would accelerate patient access. The team is developing a patient-reported questionnaire to measure tolerability and will test the gel in a pilot trial against standard serum drops.
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Background: Ocular surface disease (OSD) leading to dry eye is a global public-health problem. Symptoms significantly impact upon visual function and quality-of-life similar to that of severe angina. Therapeutic options range from patient education, optimising the local environmental, applying lubricants (regulated as MHRA Class II invasive devices), anti-inflammatory eye drops and tablets, together with physical protection of the ocular surface from blink-related biomechanical trauma with therapeutic bandage and scleral contact lenses. Our patented fluid-gel technology overcomes limitations of existing strategies by providing a resorbable long-lived dressing (FLG-1001) that has the ability to protect and repair the ocular surface. Methods and Timelines: The project comprises three work packages (WPs) with clearly defined milestones. WP1 Product Development for Commercialisation (0-9 months): In a related MRC DPFS funded proof-of-concept study, absence of local toxicity and reduction of inflammatory and fibrosis markers have been demonstrated following application of FLG-1001 in a murine corneal injury model. WP1 aims to develop a formulation to meet the clinical and practical patient needs in the treatment of OSD with the Target Product Profile identified by a patient advisory group. Technical tasks will include formulation development; sterilisation and physicochemical characterisation; and optimising manufacture to deliver nutritive substances such as allogeneic donor-serum (FLG-SED1). All data will be compiled into a technical file to support the finished product entering the clinical trial. WP2 Scale-up Manufacture (6-18 months): Will construct a GMP-compliant manufacturing process for FLG-1001 and FLG-SED1 within NHSBT for clinical trial supply. Manufacturing and quality control processes will be validated to ensure manufacture to the technical specification. Pre-clinical GLP toxicity studies are currently being conducted followed by a first-in-man safety and toxicity study of FLG-1001 during the healing phase of corneal infection (planned Q4 2018). WP3 Clinical Utility Design Dossier (0-36 months). Three parts. Clinical (C)WP1 Development of a Clinical Utility Questionnaire (0-12 months): A short-answer, PPI-coordinated daily-diary questionnaire (ocular patient device tolerability and utility questionnaire, OPTiQ)) will be developed for assessment of daily discomfort and ocular tolerability of FLG-1001 using existing symptom questionnaires, and additional psychometric items. The final utility will be made available in a variety of formats (hardcopy, web-based diary). CWP2 Clinical Safety and Tolerability Studies (6-24 months). Following HRA approval and compilation of site set-up dossiers (6-18 months), quantification of FLG-1001 and FLG-SED1 tolerability measured by OPTiQ after a single dose (Stage 1, 18-20 months) and required instillation dosing/frequency (Stage 2, 20-24 months) will be determined. CWP3 Pilot study (24-36 months) will randomise patients evaluating the tolerability of the FLG-1001, FLG-SED1 versus Allogeneic-Serum eye drops (Allo-SED) in patients with moderate to severe OSD. Impact and dissemination: Durable and protective therapy for OSD will enable patients to undertake daily activities over extended time, offering some, the ability to return to work and/or an independent life. Developing a scalable manufacturing process within NHSBT – the sole UK suppliers of serum drops at cost price – will accelerate patient access and impact. Data will be disseminated at patient group meetings, newsletters, international conferences and open-access publications.
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