Viatris Inc. (VTRS), a healthcare company, on Wednesday said the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.
The regulator has set a PDUFA goal date of October 17, 2026.
Presbyopia is an age-related decline in the eye's ability to focus on nearby objects.
The submission is supported by data from the pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary endpoints with no treatment-related serious adverse events reported.
Phentolamine ophthalmic solution 0.75% is currently approved in the U.S. for treating pharmacologically-induced mydriasis and is marketed as Ryzumvi.
Viatris shares were up more than 1% in pre-market trading after closing at $16.07 on Tuesday.
For comments and feedback contact: editorial@rttnews.com
Business News
April 10, 2026 16:21 ET Inflation data from the U.S. was the main data event this week as the conflict in the Middle East continue. The minutes of the latest Fed policy session and the survey data on the services sector also made headlines. In Europe, manufacturing orders data from Germany was in focus. Price data from China drew attention in Asia.