SimianX AI LogoSimianX AI

Record mula sa primary source

MateryalNaisumite ang aplikasyon

Opus Genetics: Naghain ng sNDA ng Viatris para sa Phentolamine sa presbyopia

Nagpasumite ang Viatris ng sNDA sa FDA para sa Phentolamine Ophthalmic Solution 0.75% sa presbyopia noong 17 Dis 2025. Ang paghain ay nakabatay sa positibong datos ng VEGA-3 Phase 3 na nagpapatunay ng bisa, kaligtasan, at tibay na nakita sa VEGA-2. Walang inihayag na petsa ng PDUFA o desisyon sa pagtanggap.

Mahahalagang fact

Na-file
Dis 19, 2025, 09:05 PM
Kaganapan
Naisumite ang aplikasyon
Direksyon
Neutral
Kumpanya
IRDOpus Genetics
Asset
Phentolamine Ophthalmic Solution 0.75%
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

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

SEC 8-K

Higit pa tungkol sa asset na ito