US-based biotechnology company Emmecell has published positive topline outcomes from a randomised Phase I extension trial of EO2002, its nonsurgical cell therapy candidate for treating corneal oedema.
Conducted at various sites across the US, the double-masked study indicated substantial improvements in both vision and corneal wellness, along with a safety profile.
It tested dose levels of 150,000, 500,000 and one million endothelial cells in patients across all groups, with each group reporting improvements in BCVA and decreases in central corneal thickness (CCT).
After six months, participants who were given 150,000 cells experienced an average gain of 11 letters in Best Corrected Visual Acuity (BCVA), while 38% of these subjects achieved a vision gain of 15 letters or more.
No ocular or treatment-related serious adverse events were observed among the trial’s 30 participants.
Emmecell co-founder and Stanford University ophthalmology chair and professor Jeffrey Goldberg said: “Emmecell is thrilled to share these promising results from our proof-of-concept trial.
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“These findings strongly support advancing EO2002 into Phase III trials, bringing us closer to providing a transformative, non-surgical treatment for patients with corneal oedema.“
In view of these results, Emmecell expects to progress the therapy into Phase III trials.
The company said its patented Magnetic Cell Delivery technology has been instrumental in promoting cell integration and enhancing visual outcomes by allowing endothelial cells to be placed precisely onto the posterior cornea.
Emmecell co-founder and chief medical advisor Roger Goldberg said: “EO2002 not only delivered robust functional improvements but also demonstrated anatomic biomarkers of efficacy, such as reduced central corneal thickness and increased endothelial cell density.
“Remarkably, a subset of patients treated at an advanced center showed a nearly 50% reduction in central guttae—suggesting true disease modification for conditions like Fuchs dystrophy.“
An estimated 50,000 corneal transplants are currently performed each year in the US.
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- Source: https://www.clinicaltrialsarena.com/news/emmecell-cell-therapy-trial/