Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 100 mM Sodium Citrate Buffer, 100 mM sodium citrate buffer solution
100 mM Buffer · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment) * Male or female 18 years or older * Receive, understand, and sign a copy of the written informed consent form * Be able to return for all study visits and willing to comp...
100 mM Buffer is an investigational small molecule being studied in cataract, an eye condition in which the lens becomes cloudy. It was evaluated in a Phase 2 clinical trial in the United States involving 45 participants. It is not an approved therapy and remains in clinical development.
100 mM Buffer is being developed by Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX. The company is the sponsor of the clinical program studying the drug in cataract.
100 mM Buffer is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study enrolled 45 participants and was randomized, double-blind, and placebo-controlled.
100 mM Buffer has been studied in one completed Phase 2 trial, NCT01602068, titled Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL. The trial enrolled 45 participants in the United States and included adults 18 years and older.
Yes. 100 mM Buffer is also known as 100 mM Sodium Citrate Buffer, or 100 mM sodium citrate buffer solution. These names refer to the same investigational product being developed by Kiora Pharmaceuticals for cataract.