TheraRadar
Data updated: May 26, 2026

OPUVIZ (aflibercept-yszy)

Ophthalmology Approved 2024-05-20
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-05-20
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: AFLIBERCEPT-YSZY

OPUVIZ Approval History

2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2024 to 2026
Mar 2026 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Update

What OPUVIZ Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
Auto-substitute OK for Eylea

Pharmacists can substitute OPUVIZ for Eylea without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OPUVIZ FDA Label Details

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.