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Upcoming Ophthalmology & Eye FDA decisions & readouts

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
PDUFA target dates and trial readouts in ophthalmology & eye, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (2)

IRD · 2026-10-17
Phentolamine ophthalmic solution 0.75%: Presbyopia (sNDA)
VTRS · 2026-10-17
MR-141 (phentolamine ophthalmic solution 0.75%)

Trial readouts (10)

EYPT · Oct 2026 (est.)
EYP-1901
RGNX · 2026-12-31
RGX-314 readout
BLTE · Jun 2027 (est.)
Tinlarebant
FDMT · Jun 2027 (est.)
4D-150 IVT
IRD · 2027-06-30
OPGx-BEST1 BIRD-1 Phase 1/2 Cohort 2 (3-month topline): BEST1-related retinal disease
AMGN · Jul 2027 (est.)
ABP 938
REGN · Nov 2027 (est.)
Cemdisiran
OTLK · Dec 2027 (est.)
bevacizumab
BIOA · 2027-12-31
BGE-102 (oral NLRP3 inhibitor) QUELL-DME Phase 2: diabetic macular edema
EYPT · 2027-12-31
DURAVYU COMO and CAPRI Phase 3 (DME): diabetic macular edema

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these ophthalmology & eye catalysts: here's why.