Industry Insight

How are corneal transplants advancing in the field of ophthalmology?

By Sarah Greenhalgh at Kerato Limited

As the global population ages, vision impairment is an increasing concern, impacting physical, cognitive and mental health. 1 Corneas are the most frequently transplanted human tissue worldwide, with around 185,000 procedures per annum, however, it is estimated that 55% of the world’s population do not have access to donor material. 2

Work between private business and university research is 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.

Effective early interventions for certain corneal infections and conditions, such as those provided by the LiQD Cornea, can reduce the need for transplant. A single-use medical device, the LiQD Cornea, 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.

Preclinical studies have been undertaken, and results have been demonstrated.

The use of the LiQD Cornea to repair damaged tissue rather than performing full transplant surgery is expected to 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.

“...it is estimated that 55% of the world’s population do not have access to donor material.,2”

To ensure these products fit seamlessly into existing clinical pathways and meet the needs of health services, experts have engaged with ophthalmology surgeons and will continue to work with them to support clinical trial design. The importance of working with patient groups to ensure that their needs are embedded into all aspects of the clinical trial is critical to help facilitate recruitment and the eventual success of the trial.

To support regulatory approval and product launch, the design of the clinical trial will be carefully considered to ensure that sufficient evidence is generated to demonstrate the effectiveness of the product – with consideration given to patient numbers, the safety of LiQD Cornea, instructions for use and ease of use within clinical settings, patient follow-up, etc.

Clinical trials demonstrating the safety and efficacy of the product in human test subjects is the first stage toward making this groundbreaking treatment available widely.

References

1. Visit: who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment
2. Gain P et al (2016), ‘Global Survey of Corneal Transplantation and Eye Banking’, JAMA Ophthalmol, Feb:134(2), 167-173