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Home › PDUFA Calendar › IRD

IRD PDUFA Date: MR-141 (phentolamine ophthalmic solution 0.75%)

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-10-17 · Opus Genetics Inc. · Presbyopia
More Ophthalmology FDA decisions →All October 2026 PDUFA dates →

The story

MR-141 (phentolamine ophthalmic solution 0.75%) is under FDA review to treat presbyopia - age-related loss of near vision (eye drops instead of reading glasses).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNVO-sogroya . 2026-06-30Same area: Rare / Genetic . Sogroya (somapacitan)REGN-otoferlin-gene-therapy . 2026-06-30Same area: Rare / Genetic . Otoferlin gene therapy (DB-OTO)RHHBY-tecentriq . 2026-10-09Same month decision . Tecentriq (atezolizumab) and Tecentriq
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

IRD run-up into the PDUFA (last ~120 days)

$5.75$3.39
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-10-17
Drug / candidateMR-141 (phentolamine ophthalmic solution 0.75%)
IndicationPresbyopia
CompanyOpus Genetics Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT04675151 · Fast Track Designation (FTD)

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See the full 2026 PDUFA calendar →

FAQ

When is the IRD PDUFA date?
The FDA PDUFA target date for IRD (Opus Genetics Inc.) is 2026-10-17 for MR-141 (phentolamine ophthalmic solution 0.75%). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is IRD's drug MR-141 (phentolamine ophthalmic solution 0.75%)?
MR-141 (phentolamine ophthalmic solution 0.75%) is Opus Genetics Inc.'s candidate under FDA review for Presbyopia.
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.