Eluminex Biosciences Receives Scientific Recognition for its Recombinant Human Collagen (rhCIII) Biosynthetic Cornea (EB-301) Program to Treat Corneal Blindness

Awarded Honors at the American Society of Cataract and Refractive Surgery (ASCRS) and the Association for Research in Vision and Ophthalmology (ARVO)

SUZHOU, China and SAN FRANCISCO, May 16, 2023 /PRNewswire/ -- Eluminex Biosciences (Eluminex) announced that its clinical pivotal study (CLARITY) evaluating a novel biosynthetic corneal implant (EB-301) currently being conducted in China was recognized for its groundbreaking work at two recent international ophthalmology meetings held in the United States.

At the American Society of Cataract and Refractive Surgery (ASCRS) meeting (May 5-8, 2023) in San Diego, California, Eluminex received two honors:

• Eluminex's oral presentation entitled "CLARITY: A pivotal study of a novel recombinant human collagen Type III (rhCIII) biosynthetic cornea (EB-301) in patients with corneal blindness" (paper 88303) presented on May 8, 2023, was recognized as winner of best paper of the scientific session on Corneal Procedures.
• Eluminex's poster presentation entitled "A novel recombinant human collagen III (rhCIII) biosynthetic cornea (EB-301) to treat corneal blindness: initial results of the CLARITY Study" (poster 88312) presented on May 7, 2023, received honorable mention recognition in the category of Cornea.

The ASCRS annual meeting is an internationally recognized scientific symposium for clinicians and researchers in the field of cataract, refractive, cornea and glaucoma surgery.

At the Association for Research in Vision and Ophthalmology (ARVO) meeting (April 23-27, 2023) in New Orleans, Louisiana, Eluminex received additional recognition:

• Eluminex's poster presentation 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 Trial)" (poster C0381) presented on April 24, 2023, received an ARVO Hot Topic 2023 award.

ARVO is the largest and most respected eye and vision research organization in the world with scientific representation from over 75 countries.

The EB-301 investigational corneal implant is manufactured from recombinant human Type III collagen (rhCIII) and is intended to treat corneal blindness secondary to stromal lesions amenable to anterior lamellar keratoplasty (ALK) surgery as an alternative to human cadaveric corneal transplants. Corneal blindness is a leading cause of vision loss globally; however, it is estimated that over half the world's population has no access to a corneal transplant. EB-301 is intended to help fulfill the critical worldwide shortage of corneal allografts.

About EB-301

EB-301 is a novel clinical stage first-in-class biosynthetic cornea derived from Type III recombinant human collagen and is in late-stage development by Eluminex Biosciences initially for the China market. There are an estimated 4 million patients in China in need of corneal transplantation but only 5000 to 8000 cases are performed each year due to lack of availability of corneal allografts.  Eluminex Bioscience obtained the exclusive global license for the manufacturing, development, and commercialization of EB-301 from FibroGen (San Francisco, CA). EB-301 is intended for the treatment of visual acuity deficits associated with corneal blindness due to stable, non-infectious stromal lesions amenable to anterior lamellar keratoplasty (ALK) as an alternative to cadaveric human donor cornea. The implant is regulated as a Class III investigational medical device. EB-301 has several potential advantages over currently available porcine corneal implants including improved corneal clarity, no need for immunosuppressants, and serve as a tissue scaffold to allow ingrowth of surrounding stromal and epithelial tissue. Prior single site investigator-initiated clinical studies have shown encouraging long-term (> 4 years) durability with improved visual acuity and no corneal melt.

About the CLARITY Study

CLARITY is an open-label, single-arm, registrational study being conducted in mainland China (Jiangsu Medical Product Agency, 20220171) with the anticipation of eventual marketing registration globally. The study will enroll approximately 85 subjects and followed for at least one year. The study is currently active and enrolling subject at multiple investigational sites in China.

About Eluminex Biosciences

Founded in February 2020, Eluminex Biosciences is a privately held global biotechnology company focusing on ophthalmic diseases and recombinant human collagen technology with its main headquarters, research/development, and manufacturing center located in Suzhou Industrial Park BioBAY and a US operational campus located in South San Francisco, California. Under the leadership of a seasoned management team, Eluminex aims to build an innovative and sustainable pipeline to address the unmet clinical needs for ophthalmic diseases and other indications to benefit patients in China and globally.

For more information, visit www.eluminexbio.com.

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SOURCE Eluminex Biosciences