Indianapolis, IN – March 10, 2021 – Price Vision Group announced today that it is the first site to initiate patient treatment in a clinical trial evaluating use an experimental drug treatment in conjunction with a surgical procedure that treats the back surface of the cornea to restore vision in patients with a condition called Fuchs Endothelial Corneal Dystrophy (FECD). More than four percent of the population over the age of 40 is at risk of developing FECD and this disease is the leading cause of corneal transplantation in the U.S.
FECD results from the loss of specific cells (endothelial cells) that line the back of the cornea, over time this leads to cloudy vision and potentially blindness. The clinical trial is being conducted in FECD patients who are already planning to undergo a surgical procedure, referred to as DSO (Descemet Stripping Only) or DWEK (Descemetorhexis without Endothelial Keratoplasty). This procedure removes diseased cells and the collagen bumps (guttae) they produce from a central area of the cornea. Normal cells then repopulate the area over time to improve vision. The clinical trial will evaluate whether administering an experimental drug, TTHX1114 (an engineered form of a natural protein called FGF-1) can accelerate and enhance the visual recovery process. Patients participating in the clinical trial will have the option to receive TTHX1114 in addition to DSO surgery or to receive DSO surgery alone.
“The Price Vision Group strives to provide state of the art care to our patients,” said Dr. Francis Price, founder of the practice. “DSO is an innovative new procedure that provides an alternative to corneal transplantation. As a provider of the DSO procedure, we are excited to participate as one of the sites in the U.S. in this clinical trial of TTHX1114.”
About FECD and corneal endothelial disorders
Corneal endothelial cells line the interior of the cornea and are critical to maintaining its appropriate hydration state, which enables the cornea to function properly. FECD, the most common corneal endothelial disorder, is the leading cause of corneal transplantation/graft in the U.S.
The hallmark of FECD is excessive loss of endothelial cells and the formation of collagen bumps (guttae), resulting in diminished vision and, in severe cases, blindness. Loss of these cells is also a contributor to poor outcomes in eye surgery, including cataract surgery.
Although transplant surgery with human donor corneas has been shown to be effective in restoring vision for many FECD patients, most patients require long‑term immune suppression therapy which can have unintended side effects. DSO, which has been developed as an alternative to corneal transplants, does not require donor tissue and therefore eliminates the need for immune suppressive drugs.
TTHX1114 is an engineered form of the naturally occurring molecule Fibroblast Growth Factor-1 (FGF-1), which stimulates cell proliferation and migration as well as protects cells from stress and injury. TTHX1114 has been engineered to increase FGF-1’s longevity in the eye, enabling its use as a pharmaceutical. The study is sponsored by San Diego-based Trefoil Therapeutics, a private biotechnology company developing therapeutics for corneal diseases.
About Price Vision Group
Price Vision Group is a d/b/a of Corneal Consultants of Indiana, P.C., an internationally recognized center for the diagnosis, treatment, and care in the field of corneal and refractive surgery. We, along with our research partner, Cornea Research Foundation of America, have conducted more than 160 studies including those that led to the FDA approval of LASIK.
For more than 30 years, The Price Vision Group has utilized the latest technology while conducting ground-breaking research to provide cutting-edge services to patients from all over the world.
In addition to training over 600 doctors from around the world, Price Vision Group surgeons have performed more cornea transplants than any other practice in North America. As some of the world’s foremost experts in corneal care, Price Vision Group are sent some of the most challenging surgical cases based on their expertise and experience with complex corneal procedures.
Marianne Price, Ph.D.
Cornea Research Foundation of America
RMG Associates, LLC