Emmetrope Ophthalmics, a leader in cell-based therapies for severe eye diseases, today announced the completion of the final dose administration in its U.S. clinical trial for EO2002, targeting the treatment of corneal edema.
This milestone marks the end of the trial phase for EO2002, a pioneering non-surgical cell therapy utilizing Emmecell's proprietary Magnetic Cell Delivery (MCD) nanotechnology. The therapy is designed to offer a significant alternative to corneal transplantation, a procedure currently considered for roughly 10% of patients with severe symptomatic corneal edema.
The trial, a randomized, double-masked, multi-center study, is set to reveal its topline results in the second half of 2024. A phase 3 pivotal study is already scheduled to commence in the first quarter of 2025.
Sumit Garg, MD, Chair of the Emmecell Cornea Advisory Board and a Professor of Ophthalmology at the University of California, Irvine, expressed optimism about the trial's progress: "The successful completion of dosing all the patients of this study represents a significant milestone for Emmecell, and it reflects the incredible enthusiasm from our investigators to help develop a non-surgical approach to treat corneal endothelial dysfunction. Potential corneal endothelial cell injections could be used to treat the entire spectrum of corneal edema.”
Noelia Kunzevitzky, PhD, COO of Emmecell, acknowledged the contributions of the various stakeholders involved: "I would like to sincerely thank all our clinical trial sites, partners, investors, and all of the site investigators for this significant achievement. It makes me very proud that we have gathered this exceptional group of individuals from some of the most prominent U.S. hospitals and clinics. As we await topline results from this trial, our investigators’ advice and support will be invaluable as we inch closer toward making injectable cell therapy a reality to cure corneal blindness globally."
Further bolstering its mission, Emmecell has recently partnered with Eversight, a leading global nonprofit eye bank, to advance cell therapies like EO2002 and contribute to the global effort to cure blindness.
Corneal edema is a condition characterized by the swelling of the cornea, the clear, dome-shaped surface that covers the front of the eye. This swelling results from an accumulation of fluid in the corneal layers, typically caused by damage to or dysfunction of the corneal endothelium, the cell layer responsible for maintaining the proper amount of fluid in the cornea. Symptoms of corneal edema can include blurred vision, halos around lights, eye pain, and a sensation of grittiness in the eye. Severe cases can lead to significant vision impairment.