Abstract
Purpose :
There remains an unmet need for corneal alternatives due to a global shortage of human allografts. EB-301 is a novel corneal implant undergoing clinical study with the potential to be the first approved biosynthetic cornea. The purpose is to present the development of EB-301 and the design of an on-going clinical registration study (CLARITY).
Methods :
EB-301 biosynthetic cornea is comprised of triple helix, recombinant human collagen III (rhCIII) derived from yeast (pichia pastoris) and chemically cross-linked. EB-301 is indicated for transplant candidates with visual acuity (VA) deficits due to stable stromal lesions, have intact Descemet’s membrane and endothelium, and amenable to anterior lamellar keratoplasty (ALK). The implant is 12mm diameter, 500µm thick, and optically clear (>87% light transmission). A prior clinical study (EudraCT 2006-006585-42) was conducted in N=10 transplant eligible subjects with impaired VA due to advanced keratoconus or stromal scar. Technical success was achieved in all subjects with improved mean best-corrected visual acuity (BCVA; 20/42 Snellen) and maintenance of corneal clarity at 4 years follow-up (F/U) without need for immunosuppression; this study served as the basis for the current CLARITY trial design.
Results :
The CLARITY study (N~85) is two-part, multicenter, single-arm, open-label registration study being conducted in China. All eligible subjects will have ALK/EB-301 implantation on Day 1 with F/U visits on Day 2, 7, 30, 60, 90, 180, 270 and 360. A safety review will be conducted after ≥ 5 subjects complete 30-days observation (Part A). If no major study modifications are needed, enrollment will begin in Part B with the same visit schedule as Part A. For both Parts A and B, study assessments presented will include adverse events, BCVA, anterior segment OCT, biomicroscopy, fundoscopy, topography, corneal global assessment, and in vivo confocal microscopy. The primary outcome measures are adverse events for Part A and BCVA at Day 360 for Part B.
Conclusions :
EB-301 is a novel rhCIII biosynthetic cornea undergoing clinical evaluation to address the worldwide shortage of human corneal allografts. Features of EB-301, its clinical development history, and the design of an active registration study (CLARITY) in China will be presented.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.