Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dexamethasone phosphate ophthalmic solution
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 ...
Top 2 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
EGP-437 with EyeGate II System is an investigational small molecule therapy being developed for Dry Eye Syndrome. It combines a dexamethasone phosphate formulation with the EyeGate II ocular iontophoresis delivery system, which uses a low electrical current to move drug into eye tissue. Kiora Pharmaceuticals, Inc. (ticker KPRX) is the developer.
EGP-437 with EyeGate II System is being studied for the treatment of Dry Eye Syndrome. The clinical program has focused on this ophthalmology indication, evaluating whether the combination of dexamethasone phosphate and the EyeGate II delivery system can improve signs and symptoms of dry eye in affected patients.
Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX, is the developer of EGP-437 with EyeGate II System. The company is advancing the asset as part of its ophthalmology pipeline, pairing the dexamethasone phosphate formulation with the EyeGate II iontophoresis platform for ocular drug delivery.
EGP-437 with EyeGate II System is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials for this asset are currently listed as active.
EGP-437 with EyeGate II System has been evaluated in the Phase 2 trial NCT00765804, titled Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye. That completed study enrolled 89 participants with Dry Eye Syndrome in the United States and used a randomized, double-blind, placebo-controlled design.