Latest news with #AURN001
Business Wire
23-04-2025
- Business
- Business Wire
Aurion Biotech Appoints Edward J. Holland, M.D., as Chief Medical Officer and Eris P. Jordan, O.D., as Chief Development Officer
SEATTLE & CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)--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 is developing AURN001, an investigational, single-administration, allogeneic cell therapy for the treatment of corneal edema secondary to corneal endothelial disease, a condition that causes progressive vision loss in millions of people worldwide. Dr. Holland has been a key supporter of Aurion since its inception, serving as Chair of the Medical Advisory Board and leading the first team of U.S. corneal surgeons to deliver the cell therapy developed by Aurion Biotech, based on foundational technology from Professor Shigeru Kinoshita at Kyoto Prefecture University of Medicine. His insights and clinical leadership have helped shape the trajectory of Aurion's development program. Dr. Jordan, a co-founder of Aurion, has been instrumental at every stage of the company's clinical journey. She led the foundational clinical trials in El Salvador, including the IOTA and ESCALON studies, and has since overseen the expansion of Aurion's clinical development program into North America. Her contributions have brought Aurion's mission to life — grounded in tireless advocacy for patients and deep collaboration with the global corneal surgeon community. 'I've had the privilege of knowing Dr. Holland for over a decade,' said Arnaud Lacoste, Ph.D., M.B.A., Chief Executive Officer of Aurion. 'His dedication to patients and his leadership in corneal care have been instrumental to the success of our program. His appointment as Chief Medical Officer further strengthens our clinical and scientific foundation as we move toward late-stage development and, ultimately, broader patient access.' 'Over the past four years, Dr. Jordan has poured her heart into this program,' Lacoste continued. 'Her leadership of our global clinical trials has been extraordinary, and her commitment to patients and surgeons alike reflects who we are as a company. I'm honored to continue working with Eris as Chief Development Officer.' Dr. Holland added, 'Joining Aurion in this capacity is both exciting and deeply meaningful. I've seen firsthand the transformative potential of AURN001, and I look forward to helping the team bring this therapy to patients who urgently need new options.' Dr. Jordan commented, 'This program has always been about patients — those we've met and those still waiting. I'm grateful to lead the development of AURN001, and to work alongside a team so deeply committed to scientific excellence and to the people we serve.' About Edward J. Holland, M.D. Dr. Holland is a globally recognized leader in cornea and external disease. His numerous honors include the Senior Achievement and Life Achievement Honor Awards from the American Academy of Ophthalmology, the Binkhorst and Lindstrom Medals from the American Society of Cataract and Refractive Surgery, and the Castroviejo Award from the Cornea Society. He has been named among the 'Best Doctors in America' and has published extensively in both basic and clinical research, with over 300 peer-reviewed articles. Dr. Holland was the co-principal investigator of the Cornea Donor Study, the largest clinical trial ever conducted in the field of cornea, and he has co-edited five editions of Cornea, the most widely read textbook on corneal disease and surgery. About Eris P. Jordan, O.D. Dr. Jordan brings over two decades of experience across clinical practice and the ophthalmic industry, and she continues to serve as a practicing clinician specializing in cornea and anterior segment. Prior to co-founding Aurion Biotech and serving as Vice President of Clinical and Medical Affairs, she held leadership roles including Senior Director of Medical Affairs at CorneaGen, Clinical Team Lead and Surgeon Educator at AcuFocus, Inc., and Executive Clinical Outcomes Specialist in Bausch & Lomb's surgical division. Before transitioning to industry, Dr. Jordan spent a decade in direct patient care and served as Clinic Director for a cornea and anterior segment surgical practice. She completed her post-graduate training at the Bascom Palmer Eye Institute—the top-ranked U.S. eye care institute—and earned both her Doctor of Optometry and Bachelor of Optical Sciences degrees in a fast-tracked program from Salus University, graduating with highest clinical honors. About Aurion Biotech Aurion Biotech's mission is to restore vision to millions of patients with life-changing regenerative therapies. The company is developing AURN001, an investigational cell therapy for corneal endothelial disease. AURN001 is the first cell therapy for the corneal endothelium to be commercially launched (in Japan) and is advancing through clinical development in North America. Aurion received the prestigious Prix Galien award for Best Start-Up in Biotech in 2022. In 2025, Alcon acquired majority ownership of Aurion Biotech. For more information, visit
Yahoo
28-03-2025
- Business
- Yahoo
Alcon buys majority stake in IPO-seeking cell therapy startup Aurion
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The leading eye-care company Alcon on Wednesday said it has acquired a majority stake in Aurion Biotech, capping months of legal wrangling over the future of the cell therapy developer. As part of the takeover, Aurion's board appointed Chief Scientific Officer Arnaud Lacoste as the company's new CEO, immediately replacing Greg Kunst. Aurion will continue as a separate company, 'with full support from Alcon,' according to Wednesday's press release. Aurion is focused on diseases that affect the endothelium, the layer of cells on the posterior surface of the cornea. Using cell therapy, the company aims to reverse vision loss and offer patients an easier recovery than treatments that involve corneal endothelial transplant procedures. Aurion has an approved product in Japan and is advancing another, AURN001, in Phase 1/2 research in the U.S. The company had generated interest among investors, raising $120 million in a 2022 financing led by Deerfield Management that included participation from Alcon. As Aurion looked for further funding, Alcon expressed interest in buying the company, but its offer was rejected, according to court documents. Aurion then made plans to go public. Alcon, however, was already a top shareholder and sued to block Aurion's IPO, losing in court in January. Deerfield also sued Alcon, saying Alcon was trying to thwart the IPO so it could buy Aurion itself at a discount. Independent analyses placed a multibillion-dollar value on Aurion even before it launched its first product in Japan and completed a clinical trial in the U.S., Deerfield said. For more than two years, Alcon 'has waged an unrelenting campaign' to take over Aurion 'at a highly discounted valuation,' Deerfield alleged. 'Alcon has sought to cut off Aurion's ability to obtain financing from sources other than Alcon.' As of February, Alcon held about 40.5% of Aurion and Deerfield held about 34%, according to Deerfield's lawsuit. Alcon's statement on Wednesday made no mention of the planned IPO. An Aurion spokesperson declined to comment to BioPharma Dive. Officials at Alcon and Deerfield didn't immediately respond to requests for comment. In Alcon's release, new Aurion CEO Lacoste said his company looks forward to 'leveraging Alcon's global resources and commercial expertise' to move AURN001 into Phase 3 development later this year. The Phase 1/2 study included 97 patients with corneal edema secondary to corneal endothelial dysfunction. Recommended Reading Biotech IPOs are the industry's lifeblood. Track how they're performing.
Yahoo
26-03-2025
- Business
- Yahoo
Alcon Acquires Majority Interest in Aurion Biotech, Inc. to Advance Innovative Cell Therapy for Corneal Endothelial Disease
Leverages Alcon's global scale with Aurion's cell therapy expertise to accelerate U.S. Phase 3 development in fall of 2025 Aurion's lead asset received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA) Positions Alcon at the leading edge of biopharma applications in ophthalmology with the potential to advance the first-ever corneal cell therapy candidate GENEVA, March 26, 2025--(BUSINESS WIRE)--Regulatory News: Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced it has acquired a majority interest in Aurion Biotech, Inc., a clinical-stage company developing advanced cell therapies to treat eye diseases. Aurion will operate as a separate company with full support from Alcon to advance its clinical-stage allogeneic cell therapy asset, AURN001, into Phase 3 for corneal edema secondary to corneal endothelial disease during the second half of 2025. Aurion will have access to the broader R&D, regulatory, medical ophthalmic and commercial capabilities of Alcon. In conjunction with this transaction, the Aurion Board has appointed Arnaud Lacoste, PhD, formerly Chief Scientific Officer, to the role of CEO of Aurion effective immediately. "Alcon is dedicated to developing and delivering innovative treatments for global unmet needs in eye care, including vision-threatening corneal endothelial disease, which affects millions of people worldwide," said David Endicott, CEO of Alcon. "Dr. Lacoste and the Aurion team have done tremendous work and their technology is a natural fit as we continue to expand our ophthalmic pharmaceutical portfolio. We recognize the exciting potential of cell therapies in ophthalmology, particularly given the shortage of available corneal tissue globally, and look forward to assisting Aurion in this promising area of patient care." Aurion has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the U.S. Food and Drug Administration (FDA) for AURN001, a novel cell therapy for the treatment of corneal edema secondary to corneal endothelial disease. AURN001 is a combination cell therapy product candidate comprised of allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). This investigational product has not been approved by the FDA. "As the global leader in eye care, Alcon will help Aurion optimize the development of AURN001," said Dr. Lacoste. "Since Aurion's formation in 2022, we've achieved significant clinical, regulatory and CMC milestones to bring this much-needed therapy to patients, because we know there is a chronic global shortage of corneal tissue. With our manufacturing innovations, we can expand cells from a single donor to produce up to 1,000 doses. We look forward to leveraging Alcon's global resources and commercial expertise as we initiate our U.S. Phase 3 trials later this year." Aurion has completed enrollment and dosing of a prospective, multi-center, randomized, double-masked, parallel-arm dose-ranging, Phase 1/2 clinical study of AURN001 (the CLARA trial). Ninety-seven subjects with corneal edema secondary to corneal endothelial dysfunction were randomized into five dosing arms at sites in the U.S. and Canada. The results of this study support the advancement of AURN001 into Phase 3 development. In September 2024, Aurion announced the first global commercial launch of this technology, Vyznova™ (which includes neltependocel), in Japan for the treatment of bullous keratopathy of the cornea. Bullous keratopathy is a sight-threatening and debilitating condition affecting the endothelial cells of the cornea causing accumulation of fluid in the form of blisters on the cornea, which can cause severe pain. Cautionary Note Regarding Forward-Looking Statements This document contains, and our officers and representatives may from time to time make, certain "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "intend," "commitment," "look forward," "maintain," "plan," "goal," "seek," "target," "assume," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our liquidity, revenue, gross margin, operating margin, effective tax rate, foreign currency exchange movements, earnings per share, our plans and decisions relating to various capital expenditures, capital allocation priorities and other discretionary items such as our market growth assumptions, our social impact and sustainability plans, targets, goals and expectations, and generally, our expectations concerning our future performance. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict such as: cybersecurity breaches or other disruptions of our information technology systems; our ability to effectively manage the risks associated with the ethical use of disruptive technologies; compliance with data privacy, identity protection and information security laws, particularly with the increased use of artificial intelligence; the impact of a disruption in our global supply chain, including the effect of tariffs, or important facilities, particularly when we single-source or rely on limited sources of supply; our ability to manage social impact and sustainability matters; our reliance on outsourcing key business functions; global and regional economic, financial, monetary, legal, tax, political and social change; the increasingly challenging economic, political and legal environment in China; terrorism, war and other resulting events such as economic sanctions and trade restrictions; our ability to manage the risks associated with operating as a third party contract manufacturer; our ability to forecast sales demand and manage our inventory levels and the changing buying patterns of our customers; our success in completing and integrating strategic acquisitions, including equity investments in early-stage companies; the success of our research and development efforts, including our ability to innovate to compete effectively; our ability to comply with the U.S. Foreign Corrupt Practices Act of 1977 and other applicable anti-corruption laws; pricing pressure from changes in third party payor coverage and reimbursement methodologies; our ability to properly educate and train healthcare providers on our products; our ability to protect our intellectual property; our ability to comply with all laws to which we may be subject; the ability to obtain regulatory clearance and approval of our products as well as compliance with any post-approval obligations, including quality control of our manufacturing; the effect of product recalls or voluntary market withdrawals; the accuracy of our accounting estimates and assumptions, including pension and other post-employment benefit plan obligations and the carrying value of intangible assets; the impact of unauthorized importation of our products from countries with lower prices to countries with higher prices; our ability to service our debt obligations; the need for additional financing through the issuance of debt or equity; the effects of litigation, including product liability lawsuits and governmental investigations; supply constraints and increases in the cost of energy; our ability to attract and retain qualified personnel; legislative, tax and regulatory reform; the impact of being listed on two stock exchanges; the ability to declare and pay dividends; the different rights afforded to our shareholders as a Swiss corporation compared to a U.S. corporation; the effect of maintaining or losing our foreign private issuer status under U.S. securities laws; and the ability to enforce U.S. judgments against Swiss corporations. Additional factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this document speak only as of the date of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at About Aurion Biotech, Inc. Aurion Biotech's mission is to restore vision to millions of patients with life-changing regenerative therapies. It received the prestigious Prix Galien award for best start-up in biotech in 2022. Aurion Biotech is advancing AURN001, an investigational single administration, allogeneic cell therapy to treat corneal edema secondary to corneal endothelial dysfunction. Aurion Biotech developed and has launched the first commercially available corneal endothelial cell therapy in Japan. To learn more, visit Connect with us on Facebook LinkedIn View source version on Contacts Investor Relations Daniel Cravens, Allen Trang+ 41 589 112 110 (Geneva)+ 1 817 615 2789 (Fort Worth) Media Relations Steven Smith+ 41 589 112 111 (Geneva)+ 1 817 551 8057 (Fort Worth)
