Abstract
Purpose :
To evaluate the safety and tolerability of magnetic corneal cell therapy (EO2002) as treatment for subjects with symptomatic corneal edema due to endothelial dysfunction.
Methods :
EO2002 lots were derived from human donor corneas. Isolated corneal endothelial cells were expanded in vitro and labeled with biocompatible magnetic nanoparticles to create magnetic human corneal endothelial cells. In the US, a dose-escalating trial assessed a single intracameral injection of EO2002 with and without endothelium brushing or Descemet stripping.
Up to 42 subjects were treated with EO2002 and followed for six months. Four doses (50K, 150K, 500K, 1M cells) were tested across 7 cohorts. Immediately after cell injection, all subjects wore an external magnetic eye patch for up to 3 hours. The first 21 treated subjects were enrolled in a dose-escalating study design with and without endothelial brushing or Descemet stripping. The last 21 subjects are being enrolled in a randomized, double-masked study design. Safety, including the absence of inflammation and stable intraocular pressure, was the primary endpoint in all subjects. The secondary outcomes were reduced corneal thickness and improved best-corrected visual acuity (BCVA).
Results :
To date, in this ongoing clinical trial, 30 subjects with symptomatic corneal edema and BCVA <20/40 have been treated with EO2002. There have been no product-related SAEs. There has been no inflammation, and the IOP remained stable in all enrolled subjects. Up to six months following injection, there was a dose-dependent sustained clinical improvement in the non-surgical arm, and none of the participants required keratoplasty.
Conclusions :
EO2002 injection is well-tolerated with no significant adverse events or changes in intraocular pressure. This novel, non-surgical treatment approach can be performed in the clinic on subjects with symptomatic corneal.
Future results from the remaining portions of the study should offer important details on secondary endpoints in this patient population and valuable information about the safety of all dosages. Further development is ongoing.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.