Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bimatoprost · 12 trials · 6 indications
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.
The number of patients who experienced one or more TEAEs
Retreatment or rescue administered for IOP lowering, determined by the investigator.
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.
Treatment modality determined by investigator.
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
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.
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.
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.
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.
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.
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.
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 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 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 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 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 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 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 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.
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.
| Arm | Type | Description |
|---|---|---|
| Bimatoprost SR 10 μg | EXPERIMENTAL | Participants 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% | OTHER | Participants 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 -095 | EXPERIMENTAL | 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 1 | EXPERIMENTAL | Participants 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 2 | EXPERIMENTAL | Participants 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 ARGOS | EXPERIMENTAL | Study 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 A | EXPERIMENTAL | Study 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 B | EXPERIMENTAL | Study 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_COMPARATOR | Primary 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) | EXPERIMENTAL | Primary 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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 μg | EXPERIMENTAL | Study Eye: bimatoprost sustained release (SR) 15 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% | ACTIVE_COMPARATOR | Study 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. |
| Timolol 0.5%: Comparator | ACTIVE_COMPARATOR | Both 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. |
| Bimatoprost Solution BID | EXPERIMENTAL | Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. |
| Bimatoprost Solution QD | EXPERIMENTAL | Vehicle 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 BID | PLACEBO_COMPARATOR | Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. |
| Name | Type | Description |
|---|---|---|
| Bimatoprost SR | DRUG | Consists of 1 Bimatoprost SR administration in the study eye. |
| LUMIGAN | DRUG | Treatment 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 Care | OTHER | Standard of care treatment based on investigator's judgement. |
| Bimatoprost (SR) | DRUG | Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR. |
| Sham Bimatoprost SR | DRUG | Up 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 Trabeculoplasty | PROCEDURE | Selective Laser Trabeculoplasty administered on Day 1. |
| Sham Selective Laser Trabeculoplasty | PROCEDURE | Sham Selective Laser Trabeculoplasty administered on Day 1. |
| Active Comparator: Timolol 0.5% | DRUG | Timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
| Sham: Applicator Without Needle | OTHER | Sham administered on Day 1, Week 16, and Week 32. |
| Timolol Vehicle (placebo) | DRUG | Timolol vehicle administered once in the morning and once in the evening for up to 20 months. |
| bimatoprost solution | DRUG | Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months. |
| Vehicle to bimatoprost solution | DRUG | Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months. |
| bimatoprost/timolol fixed combination | DRUG | - |
| bimatoprost | DRUG | - |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Timolol eye 0.5% |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Undisclosed |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol, 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
Bimatoprost is used for glaucoma, open-angle glaucoma, ocular hypertension, eyebrow hypotrichosis, and alopecia. It is a small molecule developed by AbbVie Inc. for ophthalmology and related conditions. In clinical trials, it has been studied for open-angle glaucoma, ocular hypertension, and androgenic alopecia.
Bimatoprost is a prostaglandin analog that lowers intraocular pressure by increasing the outflow of aqueous humor through the uveoscleral pathway. It is used in ophthalmology for conditions like open-angle glaucoma and ocular hypertension. The drug is also studied for effects on hair growth in conditions such as alopecia.
Bimatoprost is developed by AbbVie Inc., a biopharmaceutical company traded on the NYSE under the ticker ABBV. AbbVie conducts clinical trials for the drug across multiple indications, including glaucoma and alopecia.
Bimatoprost is in Phase 3 clinical development. It has completed four trials, including Phase 3 studies for open-angle glaucoma and ocular hypertension. The drug is investigational and not yet approved for these uses, though it is also studied for other conditions.
Bimatoprost has completed four clinical trials, including NCT03850782, NCT03891446, and NCT04285580 for open-angle glaucoma and ocular hypertension, and NCT01904721 for androgenic alopecia. These trials enrolled a total of 2067 participants across multiple countries.
Bimatoprost is the active ingredient in Latisse, a treatment for eyebrow hypotrichosis. It is also used for glaucoma and ocular hypertension. The drug is developed by AbbVie Inc. and is being studied for additional indications like alopecia.