兆科眼科(06622.HK)治療兒童近視加深藥物臨床研究具安全性及有效性
兆科眼科-B(06622.HK)公布,公司夥伴Vyluma已公布其第III期CHAMP(治療兒童近視加深的阿托品)臨床研究的首要結果。經過三年的治療及跟進,該項多中心的國際研究分析顯示NVK002作為兒童近視加深的潛在治療方案具有強大的安全性及有效性。有關結果已於昨日(27日)在加州聖地牙哥的美國視光學會(American Academy of Optometry)年會上口頭彙報。
阿托品濃度為0.01%的NVK002在各項關鍵結果指標上,都與使用安慰劑具有統計顯著性差異和臨床意義差異,包括應答者分析、球鏡度數的基線平均變化以及於第36個月的軸向長度基線平均變化。阿托品濃度為0.02%的NVK002在多個時間點均顯示有效性,包括於第36個月對比安慰劑在軸向長度上的平均變化具有統計顯著性。於第36個月,應答者分析並無統計顯著性。
NVK002在兩個劑量上都顯示出與安慰劑相似的強大的安全性及耐受性。無眼部嚴重不良事件(SAE),而非眼部SAE的發生率及因非眼部SAE而引致停藥的情況在各治療組中相類似。最常見的眼部不良事件為充血、畏光、過敏性結膜炎、眼部瘙癢及眼部刺激。
Vyluma計劃最早於2023年第一季向美國食品藥監局(FDA)提交NVK002的新藥上市申請。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.