Harrow's VEVYE Shows Results for Dry Eye Disease in ESSENCE-2 Study
Harrow's VEVYE Shows Results for Dry Eye Disease in ESSENCE-2 Study
Harrow (NASDAQ:HROW), a leading North American eyecare pharmaceutical company, is pleased to announce results from its ESSENCE‐2 open-label extension (OLE) clinical study for VEVYE (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of dry eye disease (DED). ESSENCE-2 OLE was a Phase 3, prospective, multicenter, open-label, clinical study with 202 patients, who had previously completed the ESSENCE‐2 study, receiving VEVYE in each eye twice a day for 52 weeks. The one-year study results, published in Cornea, demonstrated VEVYE's sustained safety and efficacy in treating the signs and symptoms of DED, underscoring its value in managing this chronic condition. Key findings include:
北美領先的眼科藥品公司Harrow（納斯達克：HROW）高興地宣佈了其VEVYE（環孢黴素眼用溶液）0.1％的ESSENCE-2開放標籤延長（OLE）臨床研究的結果，這是第一款並且唯一一款治療乾眼病（DED）跡象和症狀的環孢黴素。ESSENCE-2 OLE是一項第3期前瞻性，多中心，開放標籤，臨床研究，共有202名患者參加，他們先前完成了ESSENCE-2研究，每隻眼睛每天兩次接受VEVYE治療52周。 在《角膜》雜誌上公佈的一年研究結果表明，VEVYE在治療DED跡象和症狀方面具有持久的安全性和有效性，強調了其在管理這種慢性疾病中的價值。 主要發現包括：與每次隨訪基線相比，所有預先指定的療效終點均獲得統計學上的顯着改善。而角膜染色的改善很早就穩定下來，而淚液分泌持續改善，症狀學改善則隨之而來。最常見的眼部治療相關不良事件是13名患者（6.5％）出現輕度滴眼部位疼痛，6名患者（3.0％）視力降低。由於眼部不良反應（輕微灼燒/刺痛），有1名患者在52周的研究中退出。在0到10刻度（數字越高表示評分越高）上，當患者被要求評價問題“您對研究眼藥水的滿意程度有多高？”時，有33.1％的患者給出最高可能的得分10。約有91％的患者評定了5分或更高的得分，表明他們對治療感到滿意。調查人員得出結論，無水環孢黴素0.1％眼用溶液在長期使用過程中是安全且耐受性良好的。《角膜》表明VEVYE在治療乾眼病跡象和症狀方面具有持久的安全性和有效性，強調了其在管理這種慢性疾病中的價值。
- Statistically significant improvements in all prespecified efficacy endpoints compared with baseline at each visit.
- Corneal staining improvements were early and stabilized over time while tear production improved continuously and symptomatology improvement followed these effects.
- The most common ocular treatment-related adverse events were mild instillation site pain in 13 patients (6.5%) and reduced visual acuity in 6 patients (3.0%). One patient withdrew during the 52-week study due to an ocular adverse event (mild burning/stinging).
- On a 0 to 10 scale (the higher the number equating to a better rating), when patients were asked to rate the question, "How satisfied are you with the study eye drop?"— 33.1% of patients provided the highest possible rating of 10. Approximately 91% of patients rated a score of 5 or higher, indicating satisfaction with the treatment.
- Investigators conclude that water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use.
- 在每次隨訪基線的所有預定療效終點上，與基線相比都有統計學上的顯着改善。
- 角膜染色的改善很早就穩定下來，淚液產量得到持續改善，症狀學改善隨之而來。
- 最常見的眼科治療相關不良事件是輕度滴眼部位疼痛（13名患者，6.5％）和視力降低（6名患者，3.0％），1名患者由於眼部不良反應（輕微灼燒/刺痛）在52周研究期間退出。
- 在0到10的評分中（數字越高，表示評分越高），當被要求對問題“您對研究眼藥水的滿意程度有多高？”進行評分時，有33.1％的患者給出了最高的得分10。約91％的患者給出5分或以上的得分，表示他們對治療感到滿意。
- 調查人員得出結論，無水環孢黴素0.1％眼用溶液在長期使用過程中是安全且耐受性良好的。
譯文內容由第三人軟體翻譯。