Medical Device Daily Senior
Patients who suffer from corneal disease but have no access to a donor for transplant might benefit from a new biosynthetic cornea transplant, according to Eyegenix, a division of Cellular Bioengineering (CBI; Honolulu).
The company reported that results of a pilot clinical trial using a synthetic cornea for which Eyegenix holds the exclusive global license for transplantation were published this week in the peer-reviewed journal Science Translational Medicine.
Eyegenix COO Tony Lee told Medical Device Daily that what separates this technology from other synthetic corneas is the material. All the other synthetic corneas are “literally a hunk of plastic,“ he said, so cells don't grow on it and the patient is forced to use anti-inflammatory drugs and sometimes they have to wear contact lenses for comfort. “Our material is a scaffold that allows the body's own cells to grow inside it, to populate it, and it ends up being very similar to what the body had before,“ Lee said.
Patients implanted with this new kind of synthetic cornea are only required to take antibiotics for the first month, after that it is not necessary, Lee said.
While some of the patients treated in the trial have to wear contact lenses to improve their vision, it is not because of comfort as is the case with the plastic synthetic corneas, he added. Eventually, he hopes that patients that receive this synthetic cornea will not have to wear contacts at all.
“Right now we have a one-size-fits-all solution, but eventually we would like to be able to customize them so that the patients will come out seeing perfectly,“ Lee told MDD.
The publication reported two-year results of a clinical trial that transplanted bioengineered corneas into 10 patients who were visually impaired on the transplantation wait list. All patients regained nerve sensation and tear formation without the prolonged use of anti-rejection drugs, and six of the patients improved to best corrected post-operative acuity of 20/40 with contact lenses. As a group, this improvement was comparable to a cohort treated with traditional human allograft transplant.
Eyegenix has the exclusive worldwide commercial corneal transplantation rights to this biosynthetic material, which holds the potential promise to cure blindness in the estimated 10 million people who suffer from corneal disease but have no access to a donor for transplant, according to the company. Invented at the University of Ottawa and the National Research Council of Canada (Ottawa) by May Griffith, MD, David Carlsson, MD, and their colleagues, it is under collaborative development by Eyegenix, the University of Ottawa Health Research Institute, and Per Fagerholm from University of Linkoping, Sweden, the surgeon who conducted the transplants and lead author of the publication.
Eyegenix noted that corneal transplantation is a successful procedure that is performed more often than all other types of organ transplants combined, but it is only able to impact less than 2% of patients with corneal blindness worldwide due to a lack of donors. The material is unique in its approach of replacing a human donor with a completely synthetic, transplantable cornea designed to promote tissue regeneration, the company said, which can be an off-the-shelf solution to a huge access problem.
“CBI is extremely proud to be part of this effort,“ said Mark Mugiishi, MD, medical director of CBI. “Our inventors, scientific and development team members, and clinical champions have emerged from all parts of the world. We have positioned ourselves as forerunners in the race to bring vision back to 10 million blind people in the world, and that's something all of us are incredibly passionate about.“
This unique tissue scaffold uses biosynthetic collagen, produced by FibroGen (San Francisco), to encourage cells from the recipient to grow into the graft and mimic natural healing.
Eyegenix /CBI says it is preparing for expanded trials and is completing certified manufacturing facilities for large scale clinical production, both for use in the next set of clinical trials and for eventual global patient use. “Certifying our manufacturing processes and initiating a large scale global clinical trial is our next big step,“ Lee said. “We are looking forward to manufacturing a large supply of artificial corneas to meet the demand of restoring vision around the world.“
He told MDD that the company is “making modifications to the formula . . . tweaking it a little bit, and we have a larger trial planned . . . within the next year.“
Amanda Pedersen, 309-351-7774;