TISSUEBLUE (brilliant blue g)
TissueBlue is a disclosing agent used during ophthalmic procedures to help surgeons visualize the internal limiting membrane. It works by staining this specific tissue, making it stand out from the surrounding retina and epiretinal membrane. This helps patients by providing a clear visual guide for the membrane's removal during surgery.
How TISSUEBLUE Works
This drug works by selectively staining the internal limiting membrane while leaving the retina and epiretinal membrane unstained. This contrast allows for easier visualization of the membrane during surgical removal. While the exact reason for this selective binding is not yet fully understood, it provides a clear visual distinction for the surgeon.
Details
- Status
- Prescription
- First Approved
- 2019-12-20
- Patent Cliff
- 2026
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION
TISSUEBLUE Approval History
What TISSUEBLUE Treats
1 indicationsTISSUEBLUE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Internal limiting membrane staining
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01820520 | RE11-09 | Ph 3 | terminated | Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TISSUEBLUE FDA Label Details
Indications & Usage
FDA Label (PDF)TISSUEBLUE is indicated for the treatment of Internal limiting membrane staining.
TISSUEBLUE Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.