原始来源记录
重大申请已提交
Opus Genetics：Viatris 提交 Phentolamine 治疗老视的 sNDA
Viatris 于 2025 年 12 月 17 日向 FDA 提交了 Phentolamine Ophthalmic Solution 0.75% 治疗老视的 sNDA。该申请基于 VEGA-3 3 期积极数据，确认了 VEGA-2 中观察到的疗效、安全性和持久性。目前尚未公布 PDUFA 日期或受理决定。
关键事实
- 申报时间
- 2025年12月19日 21:05
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
false 0001228627 NC 0001228627 2025-12-17 2025-12-17 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 17, 2025 Opus Genetics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-34079 11-3516358 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 8 Davis Drive Durham , NC 27713 (Address of principal executive offices) (Zip Code) ( 984 ) 884-6030 (Registrant’s telephone number, including area code) N/A (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing i