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bimatoprost

Phase 3FDA approved

Eyebrow Hypotrichosis | Small molecule | Dermatology |AbbVie Inc.|Trials Updated: Jul 15, 2026

bimatoprost development status

FDA approval on record Mar 16, 2001
Approval holderAbbvie
ApplicationNDA021275
Highest phase Phase 3
Registered trials 4 across 1 sponsor since Mar 2006

bimatoprost target and mechanism

Molecular targetPTGFR
Target classAgonist
ModalitySmall molecule

Also known as Bimatoprost Solution 1, Bimatoprost 1, Bimatoprost SR, bimatoprost solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials17
Total Enrollment6,245

FDA Designations

No designations recorded

bimatoprost clinical trials

bimatoprost · 17 trials · 9 indications

Phase 3 15Phase 2 2
NCT04285580A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular HypertensionOpen-Angle Glaucoma
COMPLETED37 Analytics
NCT03891446Long-term Safety and Efficacy Extension Trial of Bimatoprost SROpen-Angle Glaucoma
COMPLETED455 Analytics
NCT03850782Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular HypertensionOpen-Angle Glaucoma
COMPLETED515 Analytics
NCT02636946A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular HypertensionGlaucoma
COMPLETED144 Analytics
NCT02507687Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED240 Analytics
NCT02250651Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED528 Analytics
NCT02247804Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED594 Analytics
NCT01765764Bimatoprost for the Treatment of Eyebrow HypotrichosisEyebrow Hypotrichosis
COMPLETED357 Analytics
NCT01241240Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED192 Analytics
NCT01217606Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED185 Analytics
PHASE3COMPLETED
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Open-Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Open-Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Open-Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics
PHASE3COMPLETED
Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
Eyebrow HypotrichosisUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
8 weeks

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Up to 12 Months

The number of patients who experienced one or more TEAEs

Duration of effect of Bimatoprost SR
Approximately 24 months

Retreatment or rescue administered for IOP lowering, determined by the investigator.

Number of patients experiencing a treatment emergent adverse event
Approximately 24 months

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Retreatment or rescue administered for IOP
Up to 48 months

Treatment modality determined by investigator.

Intraocular Pressure (IOP) at Baseline
Baseline (prior to treatment)

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.

Change From Baseline in IOP at Week 4
Baseline (prior to treatment) to Week 4

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.

Change From Baseline in IOP at Week 12
Baseline (prior to treatment) to Week 12

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.

Change From Baseline in Intraocular Pressure (IOP) at Week 24
Baseline (prior to treatment) to Week 24

IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.

Change From Baseline in Intraocular Pressure at Week 4
Baseline and Week 4

Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.

Change From Baseline in Intraocular Pressure at Week 12
Baseline and Week 12

Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.

Change From Baseline in Intraocular Pressure at Week 24
Baseline and Week 24

Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2)
Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

IOP in the Study Eye at Week 2 (Hour 0)
Week 2 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

IOP in the Study Eye at Week 2 (Hour 2)
Week 2 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

IOP in the Study Eye at Week 6 (Hour 0)
Week 6 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

IOP in the Study Eye at Week 6 (Hour 2)
Week 6 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

IOP in the Study Eye at Week 12 (Hour 0)
Week 12 (Hour 0)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

IOP in the Study Eye at Week 12 (Hour 2)
Week 12 (Hour 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
Baseline, Month 7

The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.

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

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
Baseline, Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. 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 analyzed using a two-sample t-test.

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Baseline, Week 12

IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. 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).

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

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Week 2

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Week 6

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.

Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Week 12

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

IOP
Change From Baseline in Target Area Hair Count (TAHC)
Baseline, Month 6

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).

Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Month 6

The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Lowering intraocular pressure (IOP)

Secondary Endpoints

Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes
8 Weeks
Change From Baseline in IOP at Weeks 8, 15, and 20
Baseline (prior to treatment) to Weeks 8, 15 and 20
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
First treatment to end of study (up to 525 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bimatoprost SR 10 μgEXPERIMENTALParticipants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
LUMIGAN 0.01%OTHERParticipants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Lead-in study 192024-091 or -092 or -095EXPERIMENTALStudy eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Lead-in study 192024-093 Stage 1EXPERIMENTALParticipants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Lead-in study 192024-093 Stage 2EXPERIMENTALParticipants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Lead-in study ARGOSEXPERIMENTALStudy eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Bimatoprost SR - Dose AEXPERIMENTALStudy Eye: Participants will receive 1 - 2 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
Bimatoprost SR - Dose BEXPERIMENTALStudy Eye: Participants received 1 - 3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)ACTIVE_COMPARATORPrimary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)EXPERIMENTALPrimary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)EXPERIMENTALParticipants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)EXPERIMENTALParticipants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)EXPERIMENTALParticipants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)EXPERIMENTALParticipants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.
Bimatoprost SR 15 μgEXPERIMENTALStudy Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol 0.5%: ComparatorACTIVE_COMPARATORBoth Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol 0.5%ACTIVE_COMPARATORStudy Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Bimatoprost Solution BIDEXPERIMENTALBimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Bimatoprost Solution QDEXPERIMENTALVehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
Vehicle to Bimatoprost Solution BIDPLACEBO_COMPARATORVehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Triple Combination TherapyEXPERIMENTALTriple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Combigan®ACTIVE_COMPARATORFixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
bimatoprost/timolol formulation AEXPERIMENTALOne drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
bimatoprost/timolol fixed combination ophthalmic solutionACTIVE_COMPARATOROne drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Stage 1: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 1 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 1: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 2 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 2: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle Twice DailyPLACEBO_COMPARATORStage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Interventions

NameTypeDescription
Bimatoprost SRDRUGConsists of 1 Bimatoprost SR administration in the study eye.
LUMIGANDRUGTreatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
Standard of CareOTHERStandard of care treatment based on investigator's judgement.
Bimatoprost (SR)DRUGStudy Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.
Sham Bimatoprost SRDRUGUp to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
Selective Laser TrabeculoplastyPROCEDURESelective Laser Trabeculoplasty administered on Day 1.
Sham Selective Laser TrabeculoplastyPROCEDURESham Selective Laser Trabeculoplasty administered on Day 1.
Sham: Applicator Without NeedleOTHERSham administered on Day 1, Week 16, and Week 32.
Active Comparator: Timolol 0.5%DRUGTimolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Timolol Vehicle (placebo)DRUGTimolol vehicle administered once in the morning and once in the evening for up to 20 months.
bimatoprost solutionDRUGBimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Vehicle to bimatoprost solutionDRUGVehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)DRUGOne drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solutionDRUGOne drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solutionDRUGOne drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
bimatoprost /timolol formulation A fixed combination ophthalmic solutionDRUGOne drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
bimatoprost/timolol fixed combination ophthalmic solutionDRUGOne drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
bimatoprost/timolol fixed combinationDRUG -
Bimatoprost Solution 1DRUGBimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Solution 2DRUGBimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost VehicleDRUGBimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
bimatoprostDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment * Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months Exclusion Criteria: * Current or anticipated enrollment in another investigation...

Countries:United StatesArgentinaBelgiumBrazilCanadaColombiaCzechiaDenmarkEgyptFranceGermanyHong KongIsraelItalyNew ZealandPeruPhilippinesPolandRussiaSingaporeSouth AfricaSouth KoreaSpainThailandTurkey (Türkiye)United KingdomAustraliaBulgariaHungaryIrelandSwedenMalaysiaAustriaTaiwanMexicoIndia
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Recent Changes (Last 90 Days)

MEDIUMAug 15, 2026NCT03891446TRIAL_REMOVED: changed
MEDIUMAug 15, 2026NCT03891446TRIAL_REMOVED: changed
MEDIUMAug 15, 2026NCT03891446TRIAL_REMOVED: changed

Frequently asked questions about bimatoprost

What is bimatoprost?

Bimatoprost is a small molecule drug developed by AbbVie Inc. (ticker ABBV) that is being studied in clinical development. It has been evaluated across several eye conditions, including glaucoma, ocular hypertension, and open-angle glaucoma, as well as in dermatology-related indications such as alopecia and eyebrow hypotrichosis.

What is bimatoprost used for?

Bimatoprost has been studied for glaucoma, ocular hypertension, and open-angle glaucoma, where it is evaluated for lowering intraocular pressure. It has also been investigated for alopecia and eyebrow hypotrichosis. These programs are investigational and remain in clinical development rather than representing approved uses.

What does bimatoprost target?

Bimatoprost targets PTGFR, the prostaglandin F receptor, and acts as an agonist at that receptor. This receptor activity underlies the drug's studied effects in the eye, where it is evaluated for lowering intraocular pressure in glaucoma and ocular hypertension.

Who makes bimatoprost?

Bimatoprost is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development programs for bimatoprost and its related fixed-combination ophthalmic formulations.

What phase is bimatoprost in?

Bimatoprost is in Phase 2 development overall. Some individual studies have been conducted at Phase 3, including trials of Bimatoprost SR in open-angle glaucoma and ocular hypertension, but the program as a whole is characterized as Phase 2 and investigational.

What clinical trials is bimatoprost in?

Bimatoprost has been studied in eight completed clinical trials with total enrollment of about 2,746 participants. These include NCT04285580, NCT03891446, NCT03850782, and NCT02636946, which evaluated Bimatoprost SR in open-angle glaucoma or ocular hypertension across multiple countries.

Is bimatoprost the same as Bimatoprost SR or the bimatoprost fixed combinations?

Bimatoprost is also known as Bimatoprost SR, Bimatoprost Solution 1, and Bimatoprost 1. Related names include bimatoprost/timolol fixed combination and bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution, sometimes called Triple Combination Therapy. These refer to the same active agent in different formulations or combinations.