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Noelia Kunzevitzky, Christina Fleming, Jennifer K Thoele, Roger Goldberg, Jeffrey L Goldberg; Phase 1 Multicenter Study of Magnetic Cell Therapy for Corneal Edema. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2758 – A0247.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and tolerability of magnetic cell therapy as treatment for subjects with corneal edema secondary to Fuchs’ endothelial corneal dystrophy (FECD) or pseudophakic bullous keratopathy (PBK).
Human corneal endothelial cells were isolated from donor corneas, expanded in vitro and labeled with biocompatible magnetic nanoparticles to formulateEO2002, magnetic human corneal endothelial cells.The safety and tolerability of a single intracameral injection of magnetic human cornealendothelial cells (EO2002) with and without endothelial brushing (EB) or Descemetstripping (DS) will be assessed in a phase 1, open-label, dose-escalating multicenterstudy. In total, 18 subjects with corneal edema will be enrolled in the study and willreceive a single dose of EO2002 followed by the application of an external magneticeye patch. Half of the subjects will only receive an injection of EO2002 and the otherhalf will undergo EB or DS followed by EO2002 injection. Three doses will be studiedover a 6-month follow-up period. The primary endpoints are the absence ofinflammation and a stable intraocular pressure. The secondary endpoints will assesschanges in corneal thickness and in best corrected visual acuity (BCVA).
Study enrollment for pseudophakic subjects that are surgical candidates for DSEK with BCVA <20/40 is ongoing. To date, 9 subjects were enrolled and treated with EO2002 with and without DS. No product-related SAEs have occurred.
EO2020 injection in subjects with symptomatic corneal edema is well-tolerated, with no significant adverse events or changes in intraocular pressure. Forthcoming data from the remainder of the study should provide valuable information on the safety of all doses as well as essential data on secondary endpoints in this patient population.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.
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