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Brimonidine

Phase 3FDA approved

Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Apr 24, 2013

Brimonidine development status

FDA approval on record Mar 16, 2001
Approval holderAbbvie
ApplicationNDA021262
Highest phase Phase 3
Registered trials 3 across 3 sponsors since Sep 2005

Label indication ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN P is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 ) FDA label

Brimonidine target and mechanism

Molecular targetADRA2A, ADRA2C, ADRA2B
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL844

Also known as Brimonidine Tartrate Ophthalmic Solution 0.2%, Brimonidine 0.2%, Brimonidine ophthalmic solution 0.1%, Brimonidine 0.1%, Brimonidine 0.2% ophthalmic solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials8
Total Enrollment2,590

FDA Designations

No designations recorded

Brimonidine clinical trials

Brimonidine · 8 trials · 4 indications

Phase 3 5Phase 2 3
NCT00651612Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension PatientsGlaucoma
COMPLETED604 Analytics
NCT00168363Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED207 Analytics
NCT00652483Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED433 Analytics
NCT00332384Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionOcular Hypertension
COMPLETED573 Analytics
NCT00332436Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionOcular Hypertension
COMPLETED586 Analytics
PHASE3COMPLETED
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
GlaucomaUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Ocular HypertensionUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
Day 10
lowering of intraocular pressure
Intraocular pressure (IOP)
Week 2 - Month 3
IOP
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Month 3

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.

Percentage of Patients With a Visual Field Improvement in the Study Eye
Baseline, Month 6

Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.

Secondary Endpoints

IOP
Month 6 - Month 12
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline, Month 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBrimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
2ACTIVE_COMPARATORConcurrent Brimonidine 0.2% and 0.5% Timolol
400 ug Brimonidine ImplantEXPERIMENTAL400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
200 ug Brimonidine ImplantEXPERIMENTAL200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham (no implant)SHAM_COMPARATORSham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Interventions

NameTypeDescription
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic SolutionDRUGBrimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
Concurrent brimonidine 0.2% and 0.5% timololDRUGBrimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)
brimonidineDRUG -
Brimonidine ophthalmic solution 0.1%DRUG1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Brimonidine ophthalmic solution 0.2%DRUG1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
brimonidine/timolol fixed combinationDRUG -
400 ug Brimonidine ImplantDRUG400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
200 ug Brimonidine ImplantDRUG200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham (no implant)OTHERSham Posterior Segment Drug Delivery system on Day 1 in the study eye.
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Eligibility Criteria

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

Inclusion Criteria: * Diagnosis of ocular hypertension or glaucoma * Patient requires IOP-lowering therapy in both eyes Exclusion Criteria: * Uncontrolled medical conditions * Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Countries:United StatesIndiaIsraelPhilippinesSouth KoreaUnited Kingdom
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Frequently asked questions about Brimonidine

What is Brimonidine used for?

Brimonidine is used in ophthalmology for glaucoma, open-angle glaucoma, and ocular hypertension, and it has also been studied in rhegmatogenous macula-off retinal detachment. It is a small molecule developed by AbbVie Inc. (ticker ABBV) and is in Phase 3 development.

What does Brimonidine target?

Brimonidine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B, acting as an agonist at these receptors. This receptor activity underlies its use in ophthalmic conditions such as glaucoma and ocular hypertension.

Who makes Brimonidine?

Brimonidine is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the brimonidine programs, including the ophthalmic solution and fixed combination formulations.

What phase is Brimonidine in?

Brimonidine is in Phase 3 development. It is an investigational small molecule, and the clinical program includes completed Phase 2 and Phase 3 trials. It has been studied across glaucoma, ocular hypertension, and retinal detachment indications.

What clinical trials is Brimonidine in?

Brimonidine has been evaluated in several completed trials, including NCT00652483 and NCT00651612, both Phase 3 studies in glaucoma or ocular hypertension, and Phase 2 trials NCT00972374 in retinal detachment and NCT00693485 in open-angle glaucoma. These trials enrolled a combined total of 1,244 participants.

Is Brimonidine the same as Brimonidine Tartrate Ophthalmic Solution 0.2%?

Yes, Brimonidine is also known as Brimonidine Tartrate Ophthalmic Solution 0.2%, Brimonidine 0.2%, Brimonidine ophthalmic solution 0.1%, Brimonidine 0.1%, the 400 ug Brimonidine Implant, and the Brimonidine 0.2%/Timolol 0.5% fixed combination ophthalmic solution. These names refer to the same active agent in different formulations.