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EGP-437 1.6 mA-min at 0.4 with EyeGate II System

Phase 2

Uveitis, Anterior | Small molecule | Ophthalmology |Kiora Pharmaceuticals, Inc.|Last Updated: Aug 31, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

EGP-437 1.6 mA-min at 0.4 with EyeGate II System · 1 trial · 1 indication

Phase 2 1
NCT00694135Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior UveitisUveitis, Anterior
COMPLETED40 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Uveitis, AnteriorUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects with an ACC score of zero at Days 14 and 28
Prospective study, subjects followed for 28 days

Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28

Secondary Endpoints

Time to ACC score of zero
Prospective study, subjects followed for 28 days
Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28
Prospective study, subjects followed for 28 days
Change from baseline in ACC score at Day 28
Prospective study, subjects followed for 28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EGP-437 1.6 mA-min at 0.4 mAACTIVE_COMPARATOROcular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
EGP-437 4.8 mA-min at 1.2 mAACTIVE_COMPARATOROcular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
EGP-437 10.0 mA-min at 2.5 mAACTIVE_COMPARATOROcular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
EGP-437 14.0 mA-min at 3.5 mAACTIVE_COMPARATOROcular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA

Interventions

NameTypeDescription
EGP-437 1.6 mA-min at 0.4 with EyeGate® II SystemDRUGOcular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II SystemDRUGOcular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II SystemDRUGOcular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II SystemDRUGOcular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
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Eligibility Criteria

Age Range12 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: • Non-infectious anterior uveitis Exclusion Criteria: * Uveitis of infectious etiology * Previous anterior uveitis episode ≤ 4 weeks prior to baseline * Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensiv...

Countries:United StatesIndia
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Frequently asked questions about EGP-437 1.6 mA-min at 0.4 with EyeGate II System

What is EGP-437 1.6 mA-min at 0.4 with EyeGate II System used for?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System is an investigational small molecule being developed for the treatment of anterior uveitis, an inflammatory condition of the eye. It is administered via iontophoresis using the EyeGate II System to deliver dexamethasone phosphate. The drug is currently in Phase 2 clinical development.

How does EGP-437 1.6 mA-min at 0.4 with EyeGate II System work?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System delivers dexamethasone phosphate, a corticosteroid, through the eye using iontophoresis. This method uses a mild electrical current to enhance drug penetration into ocular tissues, potentially reducing inflammation associated with anterior uveitis. The specific molecular target is not disclosed in available information.

Who is developing EGP-437 1.6 mA-min at 0.4 with EyeGate II System?

EGP-437 1.6 mA-min at 0.4 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 focused on ophthalmic therapies and is advancing this candidate through clinical trials for anterior uveitis.

What phase is EGP-437 1.6 mA-min at 0.4 with EyeGate II System in?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials has EGP-437 1.6 mA-min at 0.4 with EyeGate II System been in?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System has been studied in one completed Phase 2 trial, identified as NCT00694135. This randomized, double-blind, active-controlled study evaluated the safety and efficacy of iontophoresis and dexamethasone phosphate for treating anterior uveitis, enrolling 40 participants in the United States and India.

Is EGP-437 1.6 mA-min at 0.4 with EyeGate II System the same as dexamethasone phosphate?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System is a specific formulation and delivery method for dexamethasone phosphate. The drug combines the corticosteroid dexamethasone phosphate with the EyeGate II System, which uses iontophoresis to administer the medication. It is not simply dexamethasone phosphate alone but a proprietary delivery approach.