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 developed by Kiora Pharmaceuticals, Inc. (ticker KPRX) for cataract, an ophthalmology condition. It is also known as 100 mM Sodium Citrate Buffer or 100 mM sodium citrate buffer solution. It has been studied in a single Phase 2 clinical trial in the United States.
100 mM Buffer is being developed for cataract, the ophthalmology indication studied in its clinical program. Kiora Pharmaceuticals, Inc. (KPRX) is the developer. The only trial of this agent to date enrolled 45 participants with cataract in the United States, and that study has been completed.
100 mM Buffer is developed by Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX. The company is the sponsor of the clinical program for this small molecule in cataract. It is also referred to as 100 mM Sodium Citrate Buffer or 100 mM sodium citrate buffer solution.
100 mM Buffer is in Phase 2 development. It is investigational and has not been approved by the FDA. Kiora Pharmaceuticals, Inc. (KPRX) has completed one Phase 2 trial of the agent in cataract, and no trials of this drug are currently active.
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 with cataract in the United States and was randomized, double blind, and placebo controlled.
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 small molecule developed by Kiora Pharmaceuticals, Inc. (KPRX) for cataract, so searches under any of these names point to the same asset.