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Bimatoprost 0.03% Formulation B

Phase 3

Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Apr 17, 2019

Bimatoprost 0.03% Formulation B target and mechanism

Molecular targetPTGFR
Target classAgonist
ModalitySmall molecule

Also known as Bimatoprost 0.03% Formulation B Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment597

FDA Designations

No designations recorded

Bimatoprost 0.03% Formulation B clinical trials

Bimatoprost 0.03% Formulation B · 1 trial · 2 indications

Phase 3 1
NCT01099774Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED597 Analytics
PHASE3COMPLETED
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Baseline, Week 12

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

Average Eye IOP at Week 12
Baseline, Week 12

Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

Average Eye IOP at Week 6
Week 6

Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Average Eye IOP at Week 2
Week 2

Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bimatoprost 0.03% Formulation B Ophthalmic SolutionEXPERIMENTALBimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic SolutionACTIVE_COMPARATORBimatoprost 0.03% Ophthalmic Solution

Interventions

NameTypeDescription
Bimatoprost 0.03% Formulation B Ophthalmic SolutionDRUGOne drop administered in each eye, every evening, for 12 weeks
Bimatoprost 0.03% Ophthalmic SolutionDRUGOne drop administered in each eye, every evening, for 12 weeks
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Eligibility Criteria

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

Inclusion Criteria: * Patient has ocular hypertension or glaucoma in both eyes * Requires IOP-lowering therapy in each eye Exclusion Criteria: * Active or recurrent eye disease that would interfere with interpretation of study data in either eye * History of any eye surgery or laser in either eye...

Countries:United States
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Frequently asked questions about Bimatoprost 0.03% Formulation B

What is Bimatoprost 0.03% Formulation B?

Bimatoprost 0.03% Formulation B is an investigational ophthalmic solution being developed by AbbVie Inc. for the treatment of glaucoma. It is a small molecule formulation of bimatoprost delivered as an eye drop. The program has completed a Phase 3 clinical trial, and the asset is not approved for marketing based on the development information available.

What is Bimatoprost 0.03% Formulation B used for?

Bimatoprost 0.03% Formulation B is being studied for glaucoma, with the completed Phase 3 trial also enrolling patients with ocular hypertension. Glaucoma is a group of eye conditions involving elevated intraocular pressure that can damage the optic nerve. The drug is an investigational therapy and has not been established as a marketed treatment.

What does Bimatoprost 0.03% Formulation B target?

Bimatoprost 0.03% Formulation B targets PTGFR, the prostaglandin F receptor, and acts as an agonist at that receptor. Agonism of PTGFR in the eye is associated with increased aqueous humor outflow, which is the mechanism by which bimatoprost-class agents lower intraocular pressure in glaucoma. The drug is a small molecule ophthalmic solution.

Who makes Bimatoprost 0.03% Formulation B?

Bimatoprost 0.03% Formulation B is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this ophthalmic formulation in patients with glaucoma and ocular hypertension.

What phase is Bimatoprost 0.03% Formulation B in?

Bimatoprost 0.03% Formulation B is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The asset is investigational, and the available development information does not indicate that it has received FDA approval for any indication.

What clinical trials is Bimatoprost 0.03% Formulation B in?

Bimatoprost 0.03% Formulation B has been evaluated in the Phase 3 trial NCT01099774, titled Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. The completed study enrolled 597 patients in the United States, was randomized, double blind, and used an active control.

Is Bimatoprost 0.03% Formulation B the same as Bimatoprost 0.03% Formulation B Ophthalmic Solution?

Yes. Bimatoprost 0.03% Formulation B Ophthalmic Solution is an alternative name for Bimatoprost 0.03% Formulation B, referring to the same investigational product. Both names describe the AbbVie-developed small molecule eye drop being studied in glaucoma and ocular hypertension, so searches for either name point to the same asset.