Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EGP-437 with EyeGate II System · 1 trial · 1 indication
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
| Arm | Type | Description |
|---|---|---|
| Low Dose: DP 7.5 mA-min at 2.5 mA | ACTIVE_COMPARATOR | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA |
| High Dose: DP 10.5 mA-min at 3.5 mA | ACTIVE_COMPARATOR | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA |
| Placebo: 10.5 mA-min at 3.5 mA | PLACEBO_COMPARATOR | Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA) |
| Name | Type | Description |
|---|---|---|
| EGP-437 with EyeGate® II System | DRUG | Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System |
| Sodium citrate buffer solution with EyeGate® II System | DRUG | Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System |
Inclusion Criteria: * Have a reported history of dry eye in each eye * Be at least 12 years of age * Demonstrate a response when exposed to the Controlled Adverse Environment model Exclusion Criteria: * Have contraindications to the use of the test articles * Have known allergy or sensitivity to ...
EGP-437 with EyeGate II System is an investigational small molecule being developed for the treatment of Dry Eye Syndrome. It is administered via iontophoresis using the EyeGate II System to deliver dexamethasone phosphate. The drug is currently in clinical development and has not been approved by regulatory authorities.
EGP-437 with EyeGate II System delivers dexamethasone phosphate, a corticosteroid that works by reducing inflammation in the eye. The EyeGate II System uses iontophoresis, a technology that uses a mild electrical current to enhance drug delivery into ocular tissues. This mechanism is being studied for its potential to treat Dry Eye Syndrome.
EGP-437 with EyeGate II System is being developed by Kiora Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KPRX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for Dry Eye Syndrome.
EGP-437 with EyeGate II System is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for the treatment of Dry Eye Syndrome.
EGP-437 with EyeGate II System has been studied in one completed Phase 2 clinical trial, identified as NCT00765804. This randomized, double-blind, placebo-controlled study enrolled 89 participants with Dry Eye Syndrome in the United States. The trial evaluated the safety and efficacy of iontophoresis with dexamethasone phosphate for treating dry eye.
EGP-437 with EyeGate II System is a combination product that includes dexamethasone phosphate, a corticosteroid, delivered through the EyeGate II System. While dexamethasone phosphate is the active pharmaceutical ingredient, EGP-437 with EyeGate II System refers to the specific investigational product being developed by Kiora Pharmaceuticals for Dry Eye Syndrome.