As the global population continues to grow at an unprecedented scale, vision impairment is becoming a challenge for all countries across the world.
Globally, at least 2.2 billion people have a near or distant vision impairment. In at least 1 billion of these, vision impairment could have been prevented or is yet to be addressed.
With people living longer, this number is only set to rise further as the average age continues to increase. Most people suffering from vision impairment and blindness are over the age of 50 years.
Vision impairment poses an enormous global financial burden, with the annual global cost of productivity estimated to be US$ 411 billion.We take vision for granted, but without clear vision, we struggle to learn, walk, read, to participate in school and work.
Cornea replacements – the surgical procedure that replaces a damaged cornea with healthy tissue from a donor – is an important procedure and one of the most frequently transplanted human tissue worldwide with around 185,000 procedures per year. However, it is not being delivered at the scale required to meet growing demand. Currently, it is estimated that 55% of the world’s population does not have access to donor material.
Work between the private sector and university institutions is now seeking to combine world-leading expertise in tissue engineering and corneal physiology to advance the development of a novel treatment for the repair of corneal damage and perforation in a more economical and simple process that benefits both patient's recovery and the capacity to solve vision impairment at the necessary scale.
Effective early interventions for certain corneal infections and conditions are reducing the need for transplants. Our research team at Kerato and colleagues at the University of Montreal have undertaken preclinical studies which use a single-use medical device, named the LiQD Cornea, which is activated before being injected into the eye. In situ gelling combines host corneal stromal cells with a synthetic extracellular matrix protein sequence to support tissue healing and re-epithelialisation of the surface of the eye, resulting in new tissue that is comprised of the patient's own stromal cells, is transparent, and replicates the natural curvature of the eye.
The use of the LiQD Cornea to repair damaged tissue rather than performing full transplant surgery can greatly reduce the complexity of procedures for many patients. This is expected to reduce time in the hospital, decrease the likelihood of graft rejections and/or follow-up procedures, reduce costs for health service providers and result in better patient outcomes.
To ensure these products fit seamlessly into existing clinical pathways and meet the needs of health services, the process and trials have seen experts engage with ophthalmology surgeons. By working with them to develop the clinical trial design, we can ensure sufficient evidence is generated to demonstrate the effectiveness of the product, the safety of LiQD Cornea, instructions for use and ease of use within clinical settings, patient follow-up, etc.
This is to ensure there is clear empirical data to show the needs and care of patients are embedded into all aspects of the clinical trial - critical to helping facilitate recruitment, ensure the eventual success of the trial and, over the longer term, achieve regulatory approval. All of these are important in reducing the time taken for these products to become adopted and used within the industry.
These clinical trials will be important in demonstrating the safety and efficacy of the product in human test subjects and are essential in the regulatory approval process, contributing toward making this groundbreaking treatment available widely and provide new hope in tackling a growing global epidemic.