Emmecell Completes Final Cell Therapy Dosing in U.S. Clinical Trial for Corneal Edema

MENLO PARK, Calif., April 30, 2024 (Newswire.com)
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Emmetrope Ophthalmics LLC  (“Emmecell”), a clinical-stage biotechnology company pioneering the discovery and development of cell-based therapies for the treatment of serious eye diseases, today announced final dose administration for the last patient in its U.S. randomized, double-masked, multi-center trial assessing the safety and efficacy of EO2002 for the treatment of corneal edema.

EO2002 is a first-in-class, non-surgical cell therapy with the ability to modify disease via Emmecell’s exclusive Magnetic Cell Delivery (MCD) nanotechnology platform. EO2002 offers the promise of a treatment for corneal edema without the need for invasive and high-risk surgical procedures such as corneal transplantation. Currently, approximately 10% of patients with symptomatic corneal edema have disease severe enough to undertake the risks of corneal transplantation surgery.

“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,” said Sumit Garg, MD, Chair of the Emmecell Cornea Advisory Board and Professor of Ophthalmology at University of California, Irvine. “Potential corneal endothelial cell injections could be used to treat the entire spectrum of corneal edema.”

Topline results from both trials are anticipated in the second half of 2024, with a phase 3 pivotal study planned for the first quarter of 2025.

“I would like to sincerely thank all our clinical trial sites, partners, investors, and all of the site investigators for this significant achievement,” said Noelia Kunzevitzky, PhD, Emmecell COO. “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.”

Emmecell recently partnered with Eversight, a leading global nonprofit eye bank, to advance cell therapies like EO2002 for the treatment of eye disease through their shared commitment to curing blindness worldwide.

About Corneal Edema

When the inner-most layer of cells in the cornea — the endothelial layer — decrease in number, whether from the trauma of cataract surgery or from disease or dystrophy, the cornea swells with fluid (edema) and loses its optical clarity. Patients with corneal edema suffer from vision loss and pain. Currently, no non-surgical procedures are approved for treating advanced corneal edema; the only options for these patients are corneal transplantation surgery or endothelial keratoplasty, which are technically demanding surgical procedures with many limitations, including access to donated human eye tissue. Corneal edema is the most common indication for corneal transplantation. 

About Magnetic Cell Delivery (MCD)

MCD is a revolutionary cell therapy platform. Today’s regenerative medicine using cell therapies to replace or enhance damaged tissue is often limited by the ability to localize these cells to the target tissue. Once delivered, these cells must remain at that site to facilitate integration into the host tissue. The proprietary MCD nanotechnology platform solves the challenges of delivery, retention and integration of cell therapies to effectively localize and integrate cell therapies to the appropriate target tissue. This addresses the limitations of current surgical options for corneal edema with a safe, effective, non-surgical approach to transplant corneal endothelial cells in the eye. With the availability of an effective and safe therapeutic option for corneal edema, patients with a full range of clinically significant disease will be able to receive life-changing treatment. 

About Emmecell

Emmecell is a privately held, clinical-stage biotechnology company pioneering the discovery and development of cell-based therapies for the treatment of eye diseases via its exclusive Magnetic Cell Delivery (MCD) nanotechnology platform. Emmecell solves the challenges of delivery, retention, and integration of cell therapies to effectively localize and integrate cell therapies to the appropriate target tissue. Emmecell has a broad intellectual property (IP) portfolio and is focusing its initial efforts on ophthalmic indications, including corneal edema and macular degeneration. Headquartered in Menlo Park, California, Emmecell is also the parent company of CellMP, which provides Good Manufacturing Practices (cGMP) manufacturing services. For more information, please visit emmecell.com.

Source: Emmecell