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PDUFAApproval decision

MR-141 (phentolamine ophthalmic solution 0.75%)

Presbyopia

VTRSViatris Inc
Expected catalystOctober 17, 2026Company guidance: Oct 17, 2026

Catalyst overview

Event details

Drug or asset
MR-141 (phentolamine ophthalmic solution 0.75%)
Development stage
PDUFA
Event type
Approval decision
Indication
Presbyopia

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for MR-141 (phentolamine ophthalmic solution 0.75%) in Presbyopia. The expected timing is based on the latest available company guidance and may change.

Development notes

VEGA-3 Trial. 6/26/25- Announced positive top-line results. Targeting application to FDA in H2 2025. 02/25/26:- sNDA accepted for MR-141 in presbyopia; PDUFA decision October 17, 2026; VEGA-3 data at ASCRS/ARVO 2026. 02/26/26:- sNDA and October 17, 2026 PDUFA date reiterated in 2025 results. 04/10/26:- Full VEGA-3 Ph3 results presented at ASCRS Apr 11, 2026. PDUFA Oct 17, 2026. 05/07/26:- Q1 2026 update reiterates VEGA-3 full results at ASCRS April 2026; PDUFA Oct 17, 2026. 08/06/26:- PR No update.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Viatris Inc

VTRS · NasdaqGS
Industry
Biotechnology
Pipeline assets
13
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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