MR-141 (phentolamine ophthalmic solution 0.75%) is a Viatris Inc. program in presbyopia in adults (sNDA; RYZUMVI was already approved for pharmacologically induced mydriasis). 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: presbyopia in adults (sNDA; RYZUMVI was already approved for pharmacologically induced mydriasis) (approved Oct 16, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Viatris Inc. (VTRS). Approval record: Supplemental NDA 217064 (RYZUMVI, approved 2023 for pharmacologically induced mydriasis), presbyopia in adults, supported by the Phase 3 VEGA-2 and VEGA-3 trials, which per Opus met their primary and all key secondary endpoints. Viatris holds exclusive U.S. commercial rights. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for MR-141 (phentolamine ophthalmic solution 0.75%); 1 FDA decision is on record below.
No FDA decision for MR-141 (phentolamine ophthalmic solution 0.75%) is in our archive yet.
In our records MR-141 (phentolamine ophthalmic solution 0.75%) is FDA-approved for presbyopia in adults (sNDA; RYZUMVI was already approved for pharmacologically induced mydriasis) (approved Oct 16, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Viatris Inc. (VTRS).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.