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Aurion Biotech to Present Clinical Data at ASCRS

04/03/2024
Aurion Biotech to Present Clinical Data at ASCRS image

Aurion Biotech announced several presentations during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting to be held April 5-8, 2024 in Boston.

At Eyecelerator and ASCRS, data will be presented from the company’s Escalón and IOTA studies, which treated subjects with its combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells [CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]).

“We are delighted to share additional insights into these clinical studies, in multiple sessions at the Eyecelerator and ASCRS 2024 meetings,” Michael Goldstein, MD, president and chief medical officer, Aurion Biotech, said in a company news release. “We believe these presentations will be of significant interest to the ophthalmology community, as they highlight the exciting potential of our cell therapy to treat patients with corneal endothelial disease.”

The schedule of presentations includes:

Corneal Endothelial Cell Therapy for Corneal Endothelial Disease

  • Thursday, April 4, 2024
  • 1:00 p.m. EST
  • Eyecelerator, Omni Boston Hotel at the Seaport, Level 2 Marquis room
  • Presenter: Greg Kunst, Chief Executive Officer, Aurion Biotech

Comparison of Subjects with Corneal Edema Receiving Corneal Endothelial Cells with ROCK Inhibitor in One Eye vs. Cells Alone in the Fellow Eye

  • Sunday, April 7, 2024
  • 2:00 p.m. EST
  • ASCRS Boston Convention & Exhibition Center (BCEC) - Level 2
  • Presenters: Michael Goldstein, M.D., President & Chief Medical Officer, Aurion Biotech; Nysha Blender, O.D., Senior Director Medical Affairs, Aurion Biotech

Human Corneal Endothelial Cell Transplantation Combined with Cataract Extraction and PCIOL in Subject with Corneal Edema

  • Monday, April 8, 2024
  • 8:45 a.m. EST
  • ASCRS Boston Convention & Exhibition Center (BCEC) - Meeting Level 2, Room 259A
  • Presenter: Elizabeth Yeu, M.D., President, ASCRS; Virginia Eye Consultants

Aurion Biotech recently opened a phase 1/2 clinical trial (ABA-1 / CLARA), a prospective, multicenter, randomized, double-masked, parallel-arm cell dose-ranging study in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocel used in combination with Y-27632. Approximately 100 subjects will be randomized in sites in the U.S. and in Canada.

The ABA-1/CLARA trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is the percentage of subjects who gain 3 lines of vision at 6 months.

Aurion Biotech’s combination cell therapy recently received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), for the treatment of bullous keratopathy, marking the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease.

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