MR-141 (phentolamine ophthalmic solution 0.75%)
Presbyopia · Adults with presbyopia
VTRS · Viatris Inc.
Full timeline
3 milestonesFDA decision expected
FDA assigned an October 17, 2026 PDUFA goal date to the MR-141 supplemental NDA seeking a presbyopia indication for phentolamine ophthalmic solution 0.75%.
Viatris — MR-141 sNDA acceptance and PDUFA date↗FDA accepted the sNDA
FDA accepted the MR-141 supplemental NDA for review. MR-141 is already marketed as RYZUMVI for reversal of pharmacologically induced mydriasis; the application seeks to add presbyopia.
Viatris — MR-141 sNDA acceptance↗Pivotal Phase 3 VEGA-3 met its endpoints
In the second pivotal Phase 3 trial, MR-141 met the primary and all secondary endpoints, improving near visual acuity without compromising distance vision; no treatment-related serious adverse events were reported.
Viatris — Positive Phase 3 VEGA-3 topline results↗Related News
No related news available.