Articles from Aurion Biotech

Aurion Biotech, a clinical-stage regenerative medicine company with a mission to restore vision to millions of patients, today announced positive 12 month results from the company’s Phase 1/2 CLARA trial, which evaluated the safety, efficacy and tolerability of AURN001 (neltependocel [human corneal endothelial cells] in combination with Y-27632 rho-kinase inhibitor) in patients with corneal edema secondary to corneal endothelial dysfunction. The findings were presented at Cornea Day during the American Academy of Ophthalmology (AAO) meeting in Orlando, FL.

Aurion Biotech, a clinical-stage regenerative medicine company with a mission to restore vision to millions of patients, today announced the promotions of Andrew Torres, Ph.D., to Chief Manufacturing Officer and Sterling Chung to Chief Regulatory & Quality Officer. These strategic appointments were made as the company prepares to initiate a U.S. Phase 3 clinical trial in the first quarter of 2026.

Aurion Biotech, a clinical-stage regenerative medicine company whose mission is to restore vision to millions of patients, today announced the appointments of Edward J. Holland, M.D., as Chief Medical Officer, and Eris P. Jordan, O.D., as Chief Development Officer.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced the commercial launch of Vyznova® (generic name: neltependocel) in Japan, for the treatment of bullous keratopathy of the cornea. The Company believes this is the first approved cell therapy for the treatment of corneal endothelial disease; it has received both regulatory and reimbursement approval in Japan. The commercial launch was inaugurated with cell therapy procedures performed by Professor Shigeru Kinoshita, M.D., Ph.D., at Kyoto Prefecture University of Medicine (KPUM) in Kyoto, Japan. Professor Kinoshita pioneered the research and development of corneal endothelial cell therapy, and the proprietary process for propagating corneal endothelial cells in vitro. Several years ago, Aurion Biotech acquired the technology from Kinoshita and KPUM, and the Company has continued to innovate by scaling the manufacture of fully differentiated, allogeneic human corneal endothelial cells, the active moiety of Vyznova®.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that it will present clinical data on its allogeneic cell therapy drug candidate, AURN001, at the 42nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2024) to be held September 6-10, 2024 in Barcelona, Spain. Aurion Biotech also will present and participate in several panel discussions during the Ophthalmology Futures European Forum, which takes place September 5th in Barcelona.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) Designation for AURN001, the Company’s allogeneic cell therapy candidate for the treatment of corneal edema secondary to corneal endothelial disease.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that CEO Greg Kunst has been named winner of the Ernst & Young 2024 Entrepreneur of the Year award for the Mountain West Region.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that it has completed dosing of all subjects in its Phase 1 / 2 clinical trial (CLARA) of AURN001, an allogeneic cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.

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.

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.

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.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced it has been selected as “Regenerative Therapeutics Company of the Year” in the third annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe.

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 subject in its Phase 1 / 2 U.S. clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.

Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced several presentations during the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting to be held May 5-8, 2023 in San Diego, California.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its novel cell therapy, Vyznova™, for the treatment of bullous keratopathy of the cornea. The Company believes this is the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has appointed Dr. Jonathan Sparks as chief legal officer. Dr. Sparks will lead the company’s global legal affairs team.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has appointed Sherita Hall as vice president, clinical operations and Sterling Chung as vice president, global regulatory affairs.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has won the prestigious Prix Galien Award for Best Startup in Biotech / Pharma. The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, fosters, recognizes, and rewards excellence in scientific innovation to improve the state of human health.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has been nominated for the prestigious Prix Galien Startup Award. The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, fosters, recognizes, and rewards excellence in scientific innovation to improve the state of human health.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has appointed Michael Goldstein, M.D., M.B.A., as president and chief medical officer. Dr. Goldstein will lead the Company’s clinical strategy, development and operations; medical affairs; and manufacturing and quality teams for its first product candidate, a cell therapy to treat corneal edema secondary to endothelial dysfunction.

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has secured a $120 million financing with top-tier biotech and ophthalmology investors. The financing was led by Deerfield Management, and included existing investors Petrichor Healthcare Capital Management, Flying L Partners, Falcon Vision, an ophthalmology-focused investment platform supported by KKR, and Visionary Ventures, a leading ophthalmology-focused venture fund creating value with better insight. Alcon also participated in the financing. Funds will be disbursed to the Company based on the achievement of key clinical and operational milestones.

Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases, today announced the company’s medical advisory board, composed of the world’s most eminent ophthalmologists. The board will collaborate with the company’s executive team in clinical development, and is chaired by Edward Holland, M.D., who was recently appointed as Aurion Biotech's chief medical advisor.

Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases, today announced it has appointed Tim Largen as vice president of manufacturing. Mr. Largen is based in Seattle and will lead strategy and development of Aurion Biotech’s global cell manufacturing capabilities. His role will include managing Aurion Biotech’s internal team and as a division of CorneaGen, Inc., working with external teams at Cognate BioServices, Inc., a Charles River Company, and at S-RACMO, a joint venture of Sumitomo Chemical Company, Ltd., and Sumitomo Dainippon Pharma Company, Ltd., to help support cell production in the United States and Japan, respectively.

Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases, today announced it has appointed Daniela Drago, MS, PhD, RAC, as chief regulatory officer. Dr. Drago will be based in Boston and direct the company’s global regulatory strategies.

Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases, today announced preliminary findings from its IOTA trial, conducted in November 2020 and in May of this year, at the Clínica Quesada in San Salvador, El Salvador.

Shigeru Kinoshita, MD, PhD, has joined the medical advisory board at Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases. Professor Kinoshita is the inventor of Aurion Biotech’s lead candidate, cell therapy for the treatment of corneal endothelial disease. As a member of the company’s medical advisory board, he will continue to support the product’s clinical development.

Edward Holland, MD, has been named chief medical advisor of Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases. Dr. Holland will work closely with the Aurion Biotech executive team in advancing its lead candidate, cell therapy for the treatment of corneal endothelial disease, and in helping to expand the company’s platform of advanced therapies.

Arnaud Lacoste, MBA, PhD, has been named chief scientific officer of Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies. Arnaud will lead R&D teams based in Boston and Seattle.

Greg Kunst has been named chief executive officer of newly-launched Aurion Biotech, whose mission is to cure blindness by developing a differentiated platform of advanced therapies to treat ocular diseases. The company’s first candidate is a cell therapy for the treatment of corneal endothelial disease, which affects millions of people worldwide, with symptoms that include blurred vision, glare, discomfort and pain. Invented by world-renowned ophthalmic surgeon and research scientist Professor Shigeru Kinoshita and his distinguished colleagues at Kyoto Prefecture University of Medicine (KPUM) in Japan, corneal endothelial cell therapy has demonstrated long-term efficacy in Phase 2 and Phase 3 studies in Japan.