Opus Genetics: Viatris files sNDA for Phentolamine in presbyopia

Viatris submitted an sNDA to FDA for Phentolamine Ophthalmic Solution 0.75% in presbyopia on 17 Dec 2025. The filing rests on positive VEGA-3 Phase 3 data confirming efficacy, safety, and durability seen in VEGA-2. No PDUFA date or acceptance decision has been announced.

Key facts

Filed: Dec 19, 2025, 09:05 PM
Event: Application submitted
Direction: Neutral
Company: IRDOpus Genetics
Asset: Phentolamine Ophthalmic Solution 0.75%
Source: SEC 8-K
Confidence: Sourced

Source excerpt

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 is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share I

SEC 8-K