Biosynthetic Cornea May Compensate for Corneal Allografts Shortage

A biosynthetic cornea can effectively treat patients with corneal blindness, according to research presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2023 Annual Meeting, held in San Diego, CA, May 5 to 8, 2023. A pair of paper presentations at the meeting looked into the use of EB-301, a novel recombinant human collagen III (rhCIII) biosynthetic cornea.^1,2

“A global shortage of corneal allografts remains a significant problem. An unmet need exists for cornea alternatives,” according to the presenters. “EB-301 is a corneal substitute comprised of triple helix rhCIII recombinantly derived from yeast (pichia pastoris), chemically cross-linked, and intended for patients with corneal blindness (Snellen<20/400) due to stable stromal lesions amenable to anterior lamellar keratoplasty (ALK).”  

The device — a 12 mm diameter, 500 µm thick, and optically clear (≥87% light transmission) biosynthetic cornea — is still under review, with 85 patients enrolled in the 2-part, China-based CLARITY study (ClinicalTrials.gov Identifier: NCT00641537). 

The multicenter, single-arm, open-label registration study has 6 participants in its part A safety study, and aims to enroll 75 to 80 participants in its part B safety and efficacy study. Eligible participants underwent implantation with the biosynthetic cornea on day 1 with follow-up visits scheduled on days 2, 7, 30, 60, 90, 180, 270 and 360. 

An interim analysis will be conducted after all part A participants complete their day 30 visit. If no major study modifications are needed, enrollment will begin in Part B. 

The biosynthetic cornea was specifically designed to address the worldwide shortage of corneal allografts, a necessary component of treatment for patients with corneal blindness. Corneal blindness remains a leading cause of vision loss worldwide.

“Initial Part A CLARITY results (N=6) have demonstrated technical feasibility and appears safe with no reported serious adverse events to date,” according to the report. 

This study was limited by the small sample size of patients.