Emmecell Announces Advancements of Non-Surgical Cell Therapy for Corneal Edema

Emmecell announced positive results from its US multicenter phase 1 trial evaluating EO2002, a non-surgical cell therapy for corneal edema. The randomized, double-masked trial showed significant improvement in patients’ best corrected visual acuity (BCVA), reduction in central corneal thickness (CCT) and no adverse safety events. 

"Emmecell is thrilled to share these promising results from our proof-of-concept trial," Jeffrey L. Goldberg, MD, PhD, co-founder of Emmecell and professor and chair of ophthalmology at Stanford University said in a company press release. "These findings strongly support advancing EO2002 into phase 3 trials, bringing us closer to providing a transformative, non-surgical treatment for patients with corneal edema."

The study’s 30 participants were divided into 3 cohorts and received a different EO2002 dose level—150,000, 500,000, and 1 million cells. Across all dose levels tested, all participants showed improvement in BCVA and reduction in CCT, suggesting broad treatment efficacy. Specially in the 150,000 cohort, participants demonstrated an 11-letter mean change in BCVA after 6 months, with 38% achieving at least a 15-letter vision gain. 

Traditionally, corneal edema is treated with invasive surgeries such as corneal transplants. However, these procedures can be associated with high risk of complications and accessibility is restricted due to limited donor tissue availability worldwide. Emmecell's non-surgical approach uses their patented magnetic cell delivery technology to directly deliver endothelial cells to the posterior cornea. The strong safety and efficacy profile of EO2002 demonstrated thus far offers an opportunity to treat hundreds of eyes from a single donor cornea.

"The ability to treat corneal edema without surgery is a game-changer for patients," Ellen Koo, MD, professor of ophthalmology at the Bascom Palmer Eye Institute, University of Miami, and an investigator in the study said. "With EO2002, we could significantly expand access to treatment and improve outcomes for a larger population."