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

Phase 3

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

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

Highest phase Phase 3 (NCT01129856)
Phase scored for KPRXPhase 2
Registered trials 3 across 1 sponsor since May 2010

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

ModalitySmall molecule

Also known as Dexamethasone Phosphate Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

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

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?

EGP-437 1.6 mA-min at 0.4 with EyeGate II System is an investigational small molecule therapy delivered using the EyeGate II iontophoresis system. It is being developed by Kiora Pharmaceuticals, Inc. for the treatment of anterior uveitis, an inflammatory condition of the front part of the eye.

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 being studied for the treatment of anterior uveitis. Anterior uveitis is an inflammatory condition affecting the front portion of the eye. The drug is delivered via the EyeGate II System, which uses iontophoresis to move the therapy into ocular tissue.

Who makes 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 developed by Kiora Pharmaceuticals, Inc., which trades under the ticker KPRX. Kiora is a clinical-stage biopharmaceutical company focused on ophthalmology. The EyeGate II System is the delivery platform paired with the drug in this program.

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 development. It is an investigational therapy and has not been approved by the FDA. The program has completed one Phase 2 clinical trial evaluating the combination of iontophoresis and dexamethasone phosphate for anterior uveitis.

What clinical trials 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 has been evaluated in one completed Phase 2 trial, NCT00694135, titled Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis. The trial enrolled 40 participants across the United States and India and was randomized, double-blind, and active-controlled.