Relief For Dry Eye Disease? OKYO Pharma's Candidate Shows Durable Pain Relief In Mid-Stage Study
Relief For Dry Eye Disease? OKYO Pharma's Candidate Shows Durable Pain Relief In Mid-Stage Study
OKYO Pharma Limited (NASDAQ:OKYO) announced additional key findings from analyses of the clinical data set from the 240-patient Phase 2 trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED).
東洋製藥有限公司（納斯達克股票代碼：OKYO）公佈了對240名患者的2期臨床數據集的分析得出的其他主要發現，該試驗評估了乾眼病（DED）患者 OK-101（0.05％）眼科溶液的安全性和有效性。
These new findings include:
這些新發現包括：
- A statistically significant and durable reduction in ocular pain
- Statistically significant improvement in Tear Film Break-Up Time (TFBUT) throughout the study – a clinically important endpoint
- Multiple symptomatic improvements as observed by both data obtained from patient clinic visits as well as data from patient daily symptom diaries
- 具有統計學意義的持續減輕眼痛
- 在整個研究過程中，淚膜分解時間（TFBUT）有統計學上的顯著改善——這是一個重要的臨床終點
- 從患者門診就診中獲得的數據以及患者每日症狀日記中的數據可以觀察到多種症狀改善
These results complement the statistically significant effects reported earlier on sign and symptoms endpoints, enabling definitive Phase 3 development of OK-101.
這些結果補充了先前報告的對體徵和症狀終點的統計學顯著影響，使 OK-101 得以最終的第 3 階段開發。
The company previously reported statistically significant improvements in total conjunctival staining (a sign endpoint) as early as Day 29 and burning/stinging and blurred vision (symptom endpoints) measured by a visual analog scale (VAS) as early as Day 15 for burning/stinging (p=0.03), and at Day 29 (p = 0.01) for blurred vision.
該公司此前曾報告稱，早在第29天，總結膜染色（標誌終點）和用視覺模擬量表（VAS）測得的燒灼/刺痛和視力模糊（症狀終點）的燒灼/刺痛和視力模糊（症狀終點）早在第15天（p=0.03）和視力模糊的第29天（p = 0.01），具有統計學意義的改善。
In addition, there were significant improvements in burning/stinging (p = 0.01, 0.006, 0.003, and 0.01 at Days 15, 29, 57, and 85, respectively) and in blurred vision (p = 0.09, 0.01, 0.03 and 0.06 at Days 15, 29, 57 and 85, respectively) which demonstrated sustained improvements throughout the trial.
此外，燒灼/刺痛（分別在第15、29、57和85天爲p = 0.01、0.006、0.003和0.01）和視力模糊（分別在第15、29、57和85天爲p = 0.09、0.01、0.03和0.06）均有顯著改善，這表明整個試驗過程持續改善。
Additional data analyses also showed statistically significant improvement in ocular pain that was durable throughout the trial.
其他數據分析還顯示，眼痛有統計學上的顯著改善，這種改善在整個試驗期間持續存在。
Furthermore, OK-101 improved TFBUT as early as Day 15 and lasted throughout the trial.
此外，OK-101 早在第 15 天就對 TFBUT 進行了改進，並持續了整個試驗。
OK-101 exhibited placebo-like tolerability with a very low adverse event profile and no drug-related serious adverse events. The number of treatment-emergent adverse events (TEAEs) was observed to be similar to that of the placebo-treated group. And no severe drug-related ocular TEAEs were seen.
OK-101 表現出類似安慰劑的耐受性，不良事件概況非常低，沒有與藥物相關的嚴重不良事件。觀察到的治療緊急不良事件（TEAE）的數量與安慰劑治療組的數量相似。而且沒有發現嚴重的與藥物相關的眼部 TEAE。
Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group (n=81) and three patients in the placebo-treated group (n=79).
在 OK-101 0.05% 治療組（n=81）的一名患者和安慰劑治療組（n=79）的三名患者中觀察到可能與藥物相關的不良反應物。
Price Action: OKYO shares are down 10.01% at $1.58 on the last check Friday.
價格走勢：在週五的最後一次支票中，OKYO股價下跌10.01％，至1.58美元。
Photo by Gerax Sotelo on Unsplash
由 Gerax Sotelo 在 Unsplash 上拍攝的照片
譯文內容由第三人軟體翻譯。