Glaukos Seeks FDA Approval for Non-Invasive Keratoconus Therapy Epioxa
Glaukos Seeks FDA Approval for Non-Invasive Keratoconus Therapy Epioxa
Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal disease.
Glaukos公司（NYSE:GKOS）是一家专注于青光眼、角膜疾病和视网膜疾病治疗的新型药品和医疗科技公司，今天宣布已向美国食品药品监督管理局（FDA）提交了其新药申请（NDA），申请的药物为Epioxa（Epi-on），这是一种用于治疗角膜圆锥症的下一代角膜交联iLink疗法，角膜圆锥症是一种进行性、威胁视力的角膜疾病。
"The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye," said Thomas Burns, Glaukos chairman and chief executive officer. "We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa, which is designed to reduce procedure times, improve patient comfort and shorten recovery time,represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus."
“Epioxa的新药申请提交对我们公司而言是一个重要的里程碑，因为这使我们更接近能够为角膜圆锥症患者和眼科社区提供首个FDA批准的非侵入性角膜交联药物疗法，而该疗法不需要去除角膜上皮，眼睛前面的最外层，”Glaukos董事长兼首席执行官托马斯·伯恩斯表示。“我们期待着与FDA紧密合作，共同应对即将到来的审查过程，并继续相信Epioxa旨在减少手术时间、提高患者舒适度并缩短恢复时间，这将为患有角膜圆锥症的患者的治疗模式带来潜在的重大进展。”
译文内容由第三方软件翻译。