OMNIPRED (prednisolone acetate)
OMNIPRED is indicated for the treatment of Inflammation of the Conjunctiva; Inflammation of the Cornea.
Details
- Status
- Prescription
- First Approved
- 1973-07-10
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
OMNIPRED Approval History
What OMNIPRED Treats
2 indicationsOMNIPRED 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
OMNIPRED 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 OMNIPRED
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
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.
OMNIPRED FDA Label Details
Indications & Usage
FDA Label (PDF)OMNIPRED 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.