Suzhou, China / South San Francisco, California – (April 10, 2023) – Eluminex Biosciences announces three abstract acceptances for poster and oral presentation at the upcoming Association for Research in Vision and Ophthalmology (ARVO) meeting in New Orleans, LA, April 23-27, 2023, and at the American Society for Cataract and Refractive Surgery (ASCRS) meeting in San Diego, CA, May 5-8, 2023. The EB-301 biosynthetic cornea is an investigational device being developed to address the global shortage of human corneal allografts to treat certain forms of corneal blindness. The program background and initial results from the on-going EB-301 Part A clinical study (CLARITY Trial, Clinical trial identifier: No. 20220171, Jiangsu Medical Product Agency, Suzhou, China) will be presented.
The first presentation is a poster (#2344-C0381) entitled: EB-301: A novel recombinant human collagen-derived biosynthetic cornea as an alternative to human allografts and design of a pivotal registration study (CLARITY) will be presented on April 24, 2023, at the ARVO annual meeting from 3:15 to 5:15 pm at Poster Session 262: Corneal tissue engineering and regenerative tissue. The features of a recombinant human Type III collagen-derived (rhCIII) EB-301 corneal implant and the design of a multicenter registration study (CLARITY) being conducted in China will be presented.
The second presentation is an electronic poster (#88312) entitled: A novel recombinant human collagen III (rhCIII) biosynthetic cornea (EB-301) to treat corneal blindness: initial results of the CLARITY study will be available for review May 5-8, 2023, at the ASCRS meeting. This poster will review the background technology of the EB-301 corneal implant and early open-label safety outcomes from the Part A of the CLARITY clinical trial.
The third presentation, an oral paper (#88303) entitled CLARITY: a pivotal study of a novel recombinant human collage (rhCIII) biosynthetic cornea (EB-301) in patients with corneal blindness will be presented on May 8, 2023, at the ASCRS meeting during a scientific session on “Cornea procedures and outcomes” from 8:00 to 9:30 am. This five-minute oral presentation will summarize the Part A interim analysis from the CLARITY clinical trial.
About Eluminex Biosciences
Eluminex Biosciences is a clinical stage biotechnology company dedicated to the research and development of global innovative therapeutics with a major focus in ophthalmology and recombinant human collagen technology. Our goal is to become a leading global healthcare company in developing the next generation of advanced ocular and collagen-based therapeutics for China and beyond.
About the EB-301 Biosynthetic Cornea
EB-301 is a novel clinical stage first-in-class biosynthetic cornea derived from recombinant human collagen (triple helix, Type III) and is in late-stage development initially for the China market. EB-301 is intended for treatment of visual acuity deficits associated with certain types of corneal blindness due to stable, non-infectious stromal lesions amenable to anterior lamellar keratoplasty (ALK) as an alternative to cadaveric human donor cornea. A lack of available donor human cornea is a significant issue in China and many parts of the world – it is estimated that nearly half of the world’s population has no access to a corneal transplant.1 Approximately 8000 donor corneal transplants are conducted in China annually but there are an estimated 150,000 to 200,000 new eligible patients per year. EB-301 has the potential advantage over currently available porcine corneal implants including improved corneal clarity, no need for immunosuppressive therapy, and serve as a scaffold to allow ingrowth of surround stromal and epithelial tissue. A prior clinical study (EudraCT:2006-006585-42) has shown encouraging long term (> 4 years) durability with improved visual acuity and no corneal melt.2 Eluminex Biosciences has obtained the exclusive global license for the development of EB-301 from FibroGen (San Francisco, CA).
1 Rafat M., et al. Nature Biotechnology (2022), https://doi.org/10.1038/s41587-022-01408-w.
2 Fagerholm P., et al. Biomaterials (2014), 35:2420-27.