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AGN-210961 Formulation 1

Phase 2

Ocular Hypertension | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Aug 5, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

AGN-210961 Formulation 1 · 1 trial · 2 indications

Phase 2 1
NCT01110499Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionOcular Hypertension
COMPLETED163 Analytics
PHASE2COMPLETED
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline, Day 7

IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline, Day 29

IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1, AGN-210961 Formulation 1EXPERIMENTALAGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 2EXPERIMENTALAGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 3EXPERIMENTALAGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 4EXPERIMENTALAGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 5EXPERIMENTALAGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 6EXPERIMENTALAGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 2, AGN-210961 Formulation 7EXPERIMENTALAGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Part 2, bimatoprost ophthalmic solution 0.03%ACTIVE_COMPARATORbimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Interventions

NameTypeDescription
AGN-210961 Formulation 1DRUGAGN-210961 Formulation 1 in one eye once daily for 7 days.
AGN-210961 Formulation 2DRUGAGN-210961 Formulation 2 in one eye once daily for 7 days.
AGN-210961 Formulation 3DRUGAGN-210961 Formulation 3 in one eye once daily for 7 days.
AGN-210961 Formulation 4DRUGAGN-210961 Formulation 4 in one eye once daily for 7 days.
AGN-210961 Formulation 5DRUGAGN-210961 Formulation 5 in one eye once daily for 7 days.
AGN-210961 Formulation 6DRUGAGN-210961 Formulation 6 in one eye once daily for 7 days.
AGN-210961 Formulation 7DRUGAGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
bimatoprost ophthalmic solution 0.03%DRUGbimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
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Eligibility Criteria

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

Inclusion Criteria: \- Ocular hypertension or primary open-angle glaucoma in each eye Exclusion Criteria: * Any active ocular disease * Anticipated wearing of contact lenses during study * Anticipated use of artificial tears during study * Contraindication to pupil dilatation

Countries:United States
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Competitive Landscape -Ocular Hypertension 8 trials

Frequently asked questions about AGN-210961 Formulation 1

What is AGN-210961 Formulation 1 used for?

AGN-210961 Formulation 1 is an investigational small molecule being developed by AbbVie Inc. for the treatment of ocular hypertension. It is formulated as an ophthalmic solution and has been studied in patients with ocular hypertension and primary open-angle glaucoma.

Who makes AGN-210961 Formulation 1?

AGN-210961 Formulation 1 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in the ophthalmology therapeutic area.

What phase is AGN-210961 Formulation 1 in?

AGN-210961 Formulation 1 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 no trials are currently active.

What clinical trials is AGN-210961 Formulation 1 in?

AGN-210961 Formulation 1 has been studied in one completed Phase 2 trial, NCT01110499. This randomized, double-blind, active-controlled study evaluated the safety and efficacy of AGN-210961 ophthalmic solution compared with bimatoprost ophthalmic solution in 163 patients with glaucoma or ocular hypertension in the United States.

Is AGN-210961 Formulation 1 the same as bimatoprost?

No, AGN-210961 Formulation 1 is not the same as bimatoprost. In the completed Phase 2 trial NCT01110499, AGN-210961 ophthalmic solution was compared with bimatoprost ophthalmic solution, which served as the active control. They are distinct drug products.