PRED FORTE (prednisolone acetate)
PRED FORTE is indicated for the treatment of Inflammation of the Conjunctiva; Inflammation of the Cornea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1973-05-30
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
PRED FORTE Approval History
What PRED FORTE Treats
2 indicationsPRED FORTE is approved for 2 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation of the Conjunctiva
- Inflammation of the Cornea
PRED FORTE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PRED FORTE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 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% |
| NCT00854061 results posted | CL-PKT-0415083-P | Ph 3 | completed | Study of T-PRED(TM) Compared to Pred Forte(R) II |
| 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 |
| NCT00699803 results posted | CL-PKT-0312081-P | Ph 2 | completed | Study of T-PRED(TM) Compared to Pred Forte(R) |
| 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 |
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.
PRED FORTE FDA Label Details
Indications & Usage
FDA Label (PDF)PRED FORTE is indicated for the treatment of Inflammation of the Conjunctiva; Inflammation of the Cornea.
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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