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.
專注於治療青光眼、角膜疾病和視網膜疾病的新療法的眼科製藥和醫療技術公司Glaukos Corporation（紐約證券交易所代碼：GKOS）今天宣佈向美國食品藥品監督管理局（FDA）提交新藥申請（NDA），這是其用於治療圓錐角膜的下一代角膜交聯iLink療法，這是一種漸進式角膜交聯療法，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."
格勞科斯董事長兼首席執行官托馬斯·伯恩斯表示：「Epioxa的NDA申請對我們公司來說是一個重要的里程碑，因爲它使我們能夠爲圓錐角膜患者和眼科界提供第一種獲得美國食品藥品管理局批准的無創角膜交聯藥物療法，這種藥物不需要切除角膜上皮，即眼前的最外層。」「我們期待與美國食品藥品管理局在即將進行的審查過程中密切合作，並仍然相信旨在縮短手術時間、提高患者舒適度並縮短康復時間的Epioxa代表着圓錐角膜患者治療模式中可能取得的有意義的進展。」
