Spreading individual corneal donations to multiple patients has led three Winston-Salem health-care groups to form a startup company.
Participating in the startup are the N.C. Eye Bank, Ocular Systems Inc. and the Wake Forest Institute for Regenerative Medicine. Ocular is the sponsor and initial funder of the project, which also is benefiting from a N.C. Biotechnology Center grant.
The cornea is the transparent dome at the front of the eye that helps with focus.
The new approach, not yet tested in patients, involves isolating cells from donor corneas to grow replacement corneal tissue in the laboratory. The advantage is that cells from a single donor could benefit multiple patients with impaired vision.
The short-term focus of HCEC LLC is conducting the additional studies required to get Food and Drug Administration approval to begin studies in human patients. Gaining approval typically takes several years. HCEC stands for human cultured endothelial cells.
“We believe this innovative initiative has the potential to change the face of corneal transplantation,” said Jerry Barker, Ocular’s chief executive and HCEC’s managing partner.
He said the startup represents the culmination of more than four years of planning and research.
“The combined expertise and resources of this team will enable the progress of the research to move at a faster pace,” said Cathy Hasel, Ocular’s business operations director.
The global need for corneal tissue for transplantation far exceeds the supply, said Dean Vavra, director of N.C. Eye Bank. Each year, the N.C. Eye Bank provides corneas for more than 3,000 transplants, as well as providing tissue for research and training.
In more than 90 percent of cases, a corneal transplant restores the recipient’s vision. Unlike organ transplants, which often require waiting for months on a list, surgeons typically request the corneal tissue once a surgery date has been scheduled.
The current surgical technique is to replace a patient’s damaged cells with a very thin layer of tissue containing cells from a donor cornea. The new cells pump fluid out of the cornea, giving the patient clearer eyesight.
The goal of the new partnership is use regenerative medicine technology to meet increasing demand for corneal tissue.
“The technique of bioengineering replacement tissues using cells and scaffolds can theoretically be applied to almost any tissue in the body,” said Dr. Anthony Atala, director of the regenerative medicine.
There have been close to 14,000 beneficiaries of Ocular's corneal transplant products since it was founded in 2004. Ocular has had remarkable success with its research, particularly its EndoSerter product, which received FDA clearance in February 2011.
The device, which was invented in Winston-Salem and is manufactured in Piedmont Triad Research Park, is already being marketed in Europe and Canada.
Wake Forest Baptist Medical Center said the center and Dr. Keith Walter, a professor at Wake Forest’s medical school, receive royalties from Ocular from sales of the EndoSerter device. Walter serves on Ocular’s medical advisory board and provides consulting.