Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Prednisolone Acetate (1%) Eyedrops
Prednisolone Eyedrops · 1 trial · 1 indication
Proportion of patients with ACC count of zero at Day 14
| Arm | Type | Description |
|---|---|---|
| Iontophoretic Dexamethasone Phosphate Ophthalmic Solution | EXPERIMENTAL | Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days. |
| Prednisolone Acetate Ophthalmic Suspension (1%) | ACTIVE_COMPARATOR | Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days. |
| Name | Type | Description |
|---|---|---|
| 40 mg/mL Dexamethasone phosphate ophthalmic solution | DRUG | Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) |
| Prednisolone Acetate (1%) Eyedrops | DRUG | Prednisolone acetate (1%) eyedrops |
| 100 mM sodium citrate buffer solution | DRUG | Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution |
| Placebo Eyedrops | DRUG | Placebo Eyedrops |
Inclusion Criteria: * Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber cell count of ≥ 11 cells * Receive, understand, and sign a copy of the written informed consent form * Be able to return for all study visits and willi...
Prednisolone Eyedrops are used to treat anterior uveitis, a form of eye inflammation affecting the front part of the eye. The formulation is being developed by Kiora Pharmaceuticals as a topical ophthalmology treatment for this non-infectious inflammatory condition.
Prednisolone Eyedrops target NR3C1, the glucocorticoid receptor. Prednisolone acetate acts as an agonist at this receptor, which is the mechanism underlying its anti-inflammatory effect in the eye. The target class is an agonist, and the drug is a small molecule.
Kiora Pharmaceuticals, Inc. is developing Prednisolone Eyedrops. The company trades under the ticker KPRX. The asset is an ophthalmology-focused small molecule in development for anterior uveitis.
Prednisolone Eyedrops are in Phase 3 development. The program has completed one Phase 3 trial, and no trials are currently active. The drug remains investigational and is not approved.
Prednisolone Eyedrops have been studied in the Phase 3 trial NCT01505088, titled a Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis. The trial was completed, enrolled 193 participants, was randomized, double blind, and active controlled, and was conducted in the United States.
Yes. Prednisolone Eyedrops are also known as Prednisolone Acetate (1%) Eyedrops. The two names refer to the same Kiora Pharmaceuticals asset in development for anterior uveitis.