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）是一家專注於青光眼、角膜疾病和視網膜疾病治療的新型藥品和醫療科技公司，今天宣佈已向美國食品藥品監督管理局（FDA）提交了其新藥申請（NDA），申請的藥物爲Epioxa（Epi-on），這是一種用於治療角膜圓錐症的下一代角膜交聯iLink療法，角膜圓錐症是一種進行性、威脅視力的角膜疾病。
"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的新藥申請提交對我們公司而言是一個重要的里程碑，因爲這使我們更接近能夠爲角膜圓錐症患者和眼科社區提供首個FDA批准的非侵入性角膜交聯藥物療法，而該療法不需要去除角膜上皮，眼睛前面的最外層，」Glaukos董事長兼首席執行官托馬斯·伯恩斯表示。「我們期待着與FDA緊密合作，共同應對即將到來的審查過程，並繼續相信Epioxa旨在減少手術時間、提高患者舒適度並縮短恢復時間，這將爲患有角膜圓錐症的患者的治療模式帶來潛在的重大進展。」
