Eluminex Biosciences today announced the completion of clinical enrollment in Part A (N=5) of a two-part pivotal study (CLARITY) evaluating a novel EB-301 biosynthetic cornea being conducted in China.
| Initial Part A results to be presented at the upcoming American Society of Cataract and Refractive Surgery Annual Meeting EB-301 has the potential to be the world’s first approved rhCIII biosynthetic corneal implant for the treatment of corneal blindness SUZHOU, China and SAN FRANCISCO, Feb. 14, 2023 /PRNewswire/ -- Eluminex Biosciences today announced the completion of clinical enrollment in Part A (N=5) of a two-part pivotal study (CLARITY) evaluating a novel EB-301 biosynthetic cornea being conducted in China. 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. The CLARITY study is a registrational study being conducted in mainland China (Jiangsu Medical Product Agency, 20220171) with the anticipation of eventual marketing registration in the Greater China area. The study is a single arm, open label study being conducted at more than a dozen clinical sites in mainland China. The study consists of two parts. Part A is initial safety and feasibility and intended to evaluate at least 5 subjects. Part B is safety and effectiveness that will enroll up to 80 subjects. Enrolled subjects will be followed for 12 months with routine scheduled visits to assess safety and visual acuity outcomes. Details of the EB-301 implant and summary of initial Part A clinical results will be presented at the American Society of Cataract and Refractive Surgery, May 8, 2023, in San Diego, California. The first enrolled patient in the CLARITY study was treated by Professor Mingchang Zhang, MD, Chief of Corneal Surgery at Wuhan Union Hospital, Wuhan, China in January 2023. The patient was blind in the study eye due to prior foreign body trauma. The operative procedure was successful without any observed complications. Post-operatively, the patient has near normal vision and further improvements are anticipated. “I am pleased with the progress of her recovery thus far. I am hopeful that this new technology will bring restoration of vision to the many patients in China and around the world who are not able to receive ready access to human corneal transplants,” said Dr. Zhang. “This landmark study represents the only biosynthetic corneal program in late-stage clinical development anywhere in the world,” said Charles Semba, MD, Chief Medical Officer of Eluminex. “Corneal blindness is a leading cause of vision loss globally. There are an estimated 2 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. Our hope is to bring a new alternative to patients in China and beyond, that is proven safe and effective in restoring vision” commented Semba. 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 initially for the China market. Eluminex Biosciences 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 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.
SOURCE Eluminex Biosciences |
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