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AGN-210669

Phase 2

Glaucoma, Open-Angle | Small Molecules | Ophthalmology |AbbVie Inc.|Trials Updated: Nov 6, 2013

AGN-210669 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials3
Total Enrollment462

FDA Designations

No designations recorded

AGN-210669 clinical trials

AGN-210669 · 3 trials · 3 indications

Phase 2 2Phase 1/2 1
NCT01291108Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED125 Analytics
NCT01001195Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic SolutionGlaucoma, Open-Angle
COMPLETED165 Analytics
PHASE2COMPLETED
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Average Eye IOP
Baseline, Day 57

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.

Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline, Day 29 Hour 0

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).

Secondary Endpoints

Change From Baseline in Worse Eye IOP
Baseline, Day 57
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
Baseline, Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AGN-210669EXPERIMENTALAGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
AGN-210669 + bimatoprostEXPERIMENTALAGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
AGN-210669 + bimatoprost vehicleEXPERIMENTALAGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
bimatoprostACTIVE_COMPARATORbimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
bimatoprost + AGN-210669EXPERIMENTALbimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
bimatoprost + bimatoprost vehicleOTHERbimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
AGN-210669 ophthalmic solution, 0.1%EXPERIMENTALOne drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.075%EXPERIMENTALOne drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.05%EXPERIMENTALOne drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
bimatoprost ophthalmic solution 0.03%ACTIVE_COMPARATOROne drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.025%EXPERIMENTALAGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 vehicle ophthalmic solutionPLACEBO_COMPARATORAGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Interventions

NameTypeDescription
AGN-210669DRUGAGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprostDRUGbimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost vehicleDRUGbimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
AGN-210669 ophthalmic solution, 0.1%DRUGOne drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.075%DRUGOne drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.05%DRUGOne drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
bimatoprost ophthalmic solution 0.03%DRUGOne drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
AGN-210669 ophthalmic solution, 0.025%DRUGAGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 vehicle ophthalmic solutionDRUGAGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye * Requires bilateral treatment with an IOP-lowering medication * Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: * Use of oral, intramuscular, intravenous or topical ...

Countries:United States
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Frequently asked questions about AGN-210669

What is AGN-210669, 0.075% used for?

AGN-210669, 0.075% is an investigational ophthalmic solution being studied for open-angle glaucoma and ocular hypertension. It is a small-molecule eye drop developed by AbbVie Inc. and has been evaluated in Phase 2 clinical trials in adults aged 18 years and older in the United States.

Who makes AGN-210669?

AGN-210669 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The compound is formulated as an ophthalmic solution in concentrations including 0.075% and 0.1% and has been studied in company-sponsored Phase 2 trials in the United States.

What phase is AGN-210669 in?

AGN-210669 is in Phase 2 development. It is an investigational product and is not approved for marketing. Two completed Phase 2 trials and one completed Phase 1/Phase 2 trial have evaluated the ophthalmic solution in patients with open-angle glaucoma or ocular hypertension.

What clinical trials is AGN-210669 in?

AGN-210669 has been studied in completed trials including NCT01291108, which compared AGN-210669 ophthalmic solution with bimatoprost ophthalmic solution in 125 patients, and NCT01001195, which tested three formulations against bimatoprost in 165 patients. An earlier Phase 1/Phase 2 trial, NCT00809848, enrolled 172 patients.

Is AGN-210669 the same as AGN-210669 ophthalmic solution?

Yes. AGN-210669, AGN-210669 ophthalmic solution, and the 0.075% and 0.1% concentrations all refer to the same investigational compound from AbbVie. The different names describe the drug substance and the strength of the eye drop formulation studied in glaucoma and ocular hypertension trials.

How were the AGN-210669 trials designed?

The AGN-210669 trials were randomized, double-blind, and active-controlled, using bimatoprost ophthalmic solution as the comparator. They enrolled adults 18 years and older with open-angle glaucoma or ocular hypertension, and together the completed studies involved 290 participants across the United States.