Data updated: May 26, 2026
FLO-PRED (prednisolone acetate)
Ophthalmology
Approved 2008-01-17
1
Indication
--
Phase 3 Trials
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-01-17
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
FLO-PRED Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2008 to 2024
Oct 2014 SUPPL
Mfg · Manufacturing (CMC)
Sep 2014 SUPPL
Mfg
Feb 2014 SUPPL
Mfg
What FLO-PRED Treats
1 FDA approvalsOriginally approved for its first indication in 2008 .
- Other (1)
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04351737 PERSIST | PERSIST Study | Ph 4 | completed | Dextenza for Post-operative Treatment of Pterygium |
| NCT06679153 | VVN461-CCS-201 | Ph 2 | completed | A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis |
| NCT04168112 results posted | LINK1 | Ph 4 | completed | Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study |
| NCT04464629 | The FINNEN Study | Ph 4 | terminated | Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment |
| NCT04563299 DETeR | DETeR | Ph 4 | terminated | Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections |
| NCT01939691 MEND | 18-24978 | Ph 4 | terminated | Macular Edema Nepafenac vs. Difluprednate Uveitis Trial |
| NCT04273282 | 1909 D3 EyePoint | Ph 4 | completed | A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% |
| NCT03596723 results posted | KPI-121-C-010 | Ph 3 | terminated | KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children |
| NCT01853072 results posted | C-12-067 | Ph 3 | completed | Nepafenac Once Daily for Macular Edema - Study 1 |
| NCT01872611 results posted | C-12-071 2013-001874-12 | Ph 3 | completed | Nepafenac Once Daily for Macular Edema - Study 2 |
| NCT01482897 Hiatus | BRD 11/4-M | Ph 3 | terminated | Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica |
| NCT01448213 results posted | 2011-0329 | Ph 2 | completed | Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) |
| NCT00758199 | 2008-0036 | Ph 4 | completed | Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
FLO-PRED FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
22 international docs across 11 countries
FLO-PRED Patents & Exclusivity
Latest Patent: Oct 2028
Patents (1 active)
US7799331
Expires Oct 11, 2028
Source: FDA Orange Book
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Deep insights for FLO-PRED
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.