Corneal Endothelial Dystrophy Type 2

SEATTLE, CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today 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, Massachusetts. At Eyecelerator and ASCRS 2024, 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,” said Michael Goldstein, M.D., president and chief medical officer, Aurion Biotech. “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, multi-center, 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. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. and Canada. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit .

Allogeneic Cell Therapy for the Treatment of Corneal Edema Secondary to Corneal Endothelial Dysfunction SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that it has dosed the first Canadian subject in its Phase 1 / 2 clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction. “We are very pleased to have begun dosing subjects in this trial in Canada,” said Michael Goldstein, MD, MBA, President and Chief Medical Officer of Aurion Biotech. “Treating subjects in both the United States and Canada in our CLARA trial is an important milestone in our clinical development program. We believe that our cell therapy has the potential to revolutionize the treatment of corneal patients throughout the world.” AURN001 is a 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]). AURN001 is intended to be administered to the eye as a one-time, intracameral injection. The Phase 1 / 2 clinical trial (ABA-1, CLARA) is a prospective, multi-center, randomized, double masked, parallel-arm cell dose-ranging clinical trial 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. This 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. About Corneal Endothelial Dysfunction Corneal edema secondary to endothelial dysfunction is a sight-threatening and debilitating condition affecting millions of people throughout the world. When corneal endothelial cells die or degrade, they do not regenerate. If left untreated, corneal endothelial cell loss can cause corneal edema (swelling) and loss of vision. Although corneal transplants are effective, there are disadvantages with these procedures – PKP/DMEK/DSAEK – including limited donor organ supply. Transplants require a supply of donor corneas in a 1:1 ratio (one healthy donor cornea to treat each diseased one), yet it’s estimated that there is only one donor cornea available for every 70 diseased eyes.1 In addition, post-operative recovery for corneal transplant patients requires that they lie flat on their backs for up to three days, in order for the transplant to adhere to the corneal stroma. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. and Canada. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit . _______________ 1

SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that CEO Greg Kunst has won one of the Healthcare Leadership awards from the Puget Sound Business Journal (PSBJ). Each year, PSBJ celebrates outstanding leaders in health care around the Puget Sound area. The Healthcare Leadership awards highlight innovative and influential thinkers whose leadership has had a lasting impact. “This prestigious recognition from Puget Sound Business Journal really belongs to my incredibly talented team here at Aurion Biotech,” said Greg Kunst, CEO. “We are honored to receive this award, as it increases awareness of our transformational work, and our collaborative efforts to bring our cell therapy to millions of patients around the world who suffer from corneal endothelial diseases.” Aurion Biotech is a clinical stage company developing a novel cell therapy to treat patients with corneal endothelial disease, which affects more than 16 million people throughout the world. This off-the-shelf, ready-to-use cell therapy does not require immune matching. Aurion Biotech has acquired the intellectual property rights covering the pioneering inventions of Professor Shigeru Kinoshita, MD, Ph.D. of Kyoto Prefecture University of Medicine: cell therapy for treating corneal endothelial disease. Earlier this year, the company received regulatory approval in Japan. To date, 130 subjects have been treated in multiple completed studies involving multiple surgeons and diverse patient populations. Subjects have experienced consistent, clinically meaningful and sustained improvements in key measures of corneal health. The company launched its multi-center U.S. Phase 1/2 trial (NCT06041256) this year. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. in 2023. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit View source version on businesswire.com: Contacts Judith McGarry (corporate communications) 415-971-2900 judith.mcgarry@aurionbiotech.com Michele Gray (ophthalmology media) 917-449-9250 michele@mgraycommunications.com Beth Keshishian (biotech & business media) 917-912-7195 beth@bethkeshishian.com Source: Aurion Biotech View this news release online at: