JETREA (ocriplasmin)
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-10-17
- Routes
- INTRAVITREAL
- Dosage Forms
- INJECTABLE
JETREA Approval History
What JETREA Treats
2 FDA approvalsOriginally approved for its first indication in 2012 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02035748 results posted | M-13-056 2013-005464-25 | Ph 4 | completed | Assessment of Patients Treated With JETREA® for Vitreomacular Traction |
| NCT01429441 OASIS results posted | TG-MV-014 | Ph 3 | completed | Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole |
| NCT01889251 results posted | J-12-075 | Ph 3 | completed | A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion |
| NCT00986362 MIC results posted | TG-MV-009 | Ph 2 | completed | Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy |
| NCT00913744 MIVI-5 results posted | TG-MV-005 | Ph 2 | completed | Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion |
| NCT01159665 MIVI-10 results posted | TG-MV-010 | Ph 2 | completed | The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV) |
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.
JETREA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment