Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
100 mM buffer · 2 trials · 2 indications
Proportion of patients with ACC count of zero at Day 14
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
| 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. |
| Dexamethasone Phosphate Ophthalmic | EXPERIMENTAL | Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) |
| 100 mM Sodium Citrate Buffer | PLACEBO_COMPARATOR | Placebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) |
| 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 |
| Dexamethasone Phosphate Ophthalmic | DRUG | Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) |
| 100 mM Sodium Citrate Buffer | DRUG | Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution |
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...
100 mM Buffer is an investigational small molecule being developed by Kiora Pharmaceuticals for use in ophthalmology. It is being studied for the treatment of cataract and anterior uveitis, which are conditions affecting the eye. The drug is currently in clinical development and has not been approved by regulatory authorities.
100 mM Buffer is a small molecule being developed for ophthalmic conditions. The specific molecular target of 100 mM Buffer has not been disclosed. The drug is being studied for its potential effects in treating cataract and anterior uveitis, but the exact mechanism of action is not publicly detailed.
100 mM Buffer is being developed by Kiora Pharmaceuticals, Inc., a biopharmaceutical company. Kiora Pharmaceuticals is publicly traded under the ticker symbol KPRX on the NASDAQ stock exchange. The company is focused on developing treatments for ophthalmic diseases.
100 mM Buffer is in Phase 2 clinical development. It has completed a Phase 2 trial for cataract and a Phase 3 trial for anterior uveitis, both of which are now completed. The drug remains investigational and has not received FDA approval for any indication.
100 mM Buffer has been studied in two completed clinical trials. NCT01505088 was a Phase 3 trial for anterior uveitis with 193 participants, and NCT01602068 was a Phase 2 trial for cataract with 45 participants. Both trials were conducted in the United States and have been completed.
100 mM Buffer is not the same as dexamethasone phosphate. The clinical trials for 100 mM Buffer involved iontophoretic delivery of dexamethasone phosphate ophthalmic solution, but 100 mM Buffer itself is a separate investigational drug being developed by Kiora Pharmaceuticals. The trials evaluated the safety and efficacy of the dexamethasone phosphate solution, not 100 mM Buffer as a distinct agent.