FDA Approves Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of PresbyopiaPONTE VEDRA, Fla., Oct. 18, 2023 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and Drug Administration (FDA) has approved Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults.

FDA批准Qlosi（盐酸毛果芸香碱眼用溶液）0.4%用于治疗老花眼VEDRA，佛罗里达州，2023年10月18日/PRNewswire/-Orasis Pharmaceuticals，一家专注于重塑视力可能性的新兴眼科制药公司，今天宣布美国食品和药物管理局（FDA）已批准Qlosi™ （盐酸毛果芸香碱眼用溶液）0.4%治疗成人老花眼。

Qlosi is expected to be commercially available in the U.S. in the first half of 2024.'The FDA approval of Qlosi marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision,' said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals.

Qlosi预计将于2024年上半年在美国上市销售。“FDA批准Qlosi标志着Orasis的一个巨大里程碑，因为我们继续致力于为美国数百万人提供灵活的治疗选择老花眼或模糊的近视，”Orasis Pharmaceuticals首席执行官Elad Kedar说。

'I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible.'Qlosi (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day. Qlosi demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision.

“我感谢Orasis团队，我们的战略合作伙伴，临床研究人员以及参与我们临床试验的患者，他们都使这一成就成为可能。”Qlosi（发音为CLOH-see）是一种处方滴眼液，可以每天使用，也可以根据需要使用，每天最多使用两次。Qlosi在给药后20分钟显示出功效，并且在第15天测量可以持续长达8小时，以改善近视力而不影响距离或夜视。

Qlosi is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.'Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs,' said Paul Karpecki, O.D., FAAO, Director, Cornea and External Disease, Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College o.

Qlosi是一种不含防腐剂的毛果芸香碱配方，毛果芸香碱是一种成熟的眼保健治疗药物，旨在实现功效，安全性和舒适性之间的最佳平衡肯塔基眼科研究所角膜和外部疾病主任，O.D.保罗·卡佩基（Paul Karpecki）和肯塔基大学皮克维尔分校副教授说，与年龄相关，视力模糊的患者需要灵活的治疗方案，以较少的权衡方式管理老花眼。