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Upcoming Ophthalmology & Eye FDA decisions & readouts

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 (1)

OTLK · 2026-07-29
bevacizumab — Age-Related Macular Degeneration

Trial readouts (24)

ANIP · Jul 2026 (est.)
Yutiq — Uveitis
OCGN · Jul 2026 (est.)
OCU410ST — Center Involved Diabetic Macular Edema
KOD · Aug 2026 (est.)
Tarcocimab Tedromer — Wet Age-related Macular Degeneration
EYPT · Aug 2026 (est.)
EYP-1901 — Wet Age Related Macular Degeneration
RGNX · Aug 2026 (est.)
Ranibizumab — Neovascular Age-Related Macular Degeneration (nAMD)
VNDA · Sep 2026 (est.)
VSJ-110 — Dry Eye
EYPT · Oct 2026 (est.)
EYP-1901 — Wet Age Related Macular Degeneration
ANNX · Oct 2026 (est.)
Tanruprubart — Geographic Atrophy
KPRX · Nov 2026 (est.)
KIO-104 — Macular Edema
SKYE · Nov 2026 (est.)
SBI-100 Ophthalmic Emulsion, — Obesity
FDMT · 2026-H2
4D-150 IVT — Macular Neovascularization Secondary to Age-Related Macular Degeneration
OCUL · Jan 2027 (est.)
Otx-Tki — Neovascular Age-related Macular Degeneration
KOD · Feb 2027 (est.)
KSI-101 — Macular Edema Secondary to Inflammation
SGP · Feb 2027 (est.)
Bimatoprost Implant System — Glaucoma
FDMT · Mar 2027 (est.)
4D-150 IVT — Neovascular (Wet) Age-Related Macular Degeneration
KOD · Apr 2027 (est.)
KSI-101 — Macular Edema Secondary to Inflammation
FDMT · Jun 2027 (est.)
4D-150 IVT — Macular Neovascularization Secondary to Age-Related Macular Degeneration
BLTE · Jun 2027 (est.)
Tinlarebant — Geographic Atrophy
ALVO · Jul 2027 (est.)
Eylea Hd — Diabetic Macular Edema
AMGN · Jul 2027 (est.)
ABP 938 — Neovascular Age-related Macular Degeneration
EYPT · Oct 2027 (est.)
EYP-1901 — Diabetic Macular Edema
REGN · Nov 2027 (est.)
Cemdisiran — Age-related Macular Degeneration (AMD)
RGNX · Dec 2027 (est.)
Ranibizumab — Diabetic Macular Edema
OTLK · Dec 2027 (est.)
bevacizumab — Age-Related Macular Degeneration
We don't show an approval percentage for these ophthalmology & eye catalysts — here's why.