Hyderabad: A revolutionary approach to treat chemical burns in the eye is beginning clinical trials. For the first time, a tissue-softening enzyme – collagenase – will be used in patients who have suffered acid attacks or industrial accidents.
The first-in-man trial will examine how effective the enzyme is at softening the underlying tissue in the eye, allowing the patients’ own stem cells to repair the damage and restore the patient’s sight.
The trial involving 30 patients is funded by the Ulverscroft Foundation, a UK-based charity that supports organisations helping the visually impaired. It will be carried out in collaboration with Dr Sayan Basu (Clinician) and Dr Vivek Singh (Scientist) at L V Prasad Eye Institute in Hyderabad.
The clinical trial follows research by a team from Newcastle University, UK, who earlier this year showed that applying collagenase to the cornea softens the underlying tissue, allowing the stem cells situated there to repair any damage.
“Suitable participants for the trial will be selected by an assessment team at the L V Prasad Eye Institute after rigorous medical and ethical approval, and results from the trial are expected in 2021,” said Dr Sayan Basu, Director for the Centre for Ocular Regeneration, L V Prasad Eye Institute.
“If the trial is successful, it can save time and money in treating alkali burn patients, without the need for long term follow-up and the use of limbal transplantation. Recovery too can be faster for the patient,” said Dr Vivek Singh, Lead Scientist at L V Prasad Eye Institute.
Every year, about two million people worldwide become blind due to corneal trauma, with 1 in every 5 cases caused by chemical burns to the eye. The tissue-softening enzyme collagenase can prevent loss of corneal stem cells following an injury, and could prevent patients from losing their sight. It offers hope to almost 500,000 people a year who lose their sight due to chemical burns including acid attacks.
Professor Che Connon, director of the study and leader of the Tissue Engineering Lab at Newcastle University, said: “The simplicity and relative low cost of this therapy compared to existing approaches in which stem cells have to be transplanted is a game-changer. It greatly expands the number of potential patients being treated for corneal burns across the world, and may well have applications in other diseases.”
The technology behind the clinical trial: Previous research by the Newcastle team recreated the effects of chemical burns and treated the wounded, stiffened areas of the cornea using small and localised doses of collagenase. The enzyme made the area once again pliable and able to support the patient’s own stem cells and promote healing.
The collagenase formulation has already been approved for related therapeutic applications by both the US Food and Drug Administration and the European Medicine Agency, so the team was quickly able to take it into clinical trial.
Dr Ricardo Gouveia, Research Fellow at Newcastle University and lead author of the research, is very optimistic about this next stage: “As a scientist it is exceptionally rewarding to be involved in a bench-to-bedside project, using a scientific discovery to create a new treatment that benefits patients and helps improve lives. This is especially true when such work is made possible by the support of a civil society organisation like the Ulverscroft Foundation.”