Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bimatoprost formulation A · 4 trials · 4 indications
The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
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).
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.
Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
| Arm | Type | Description |
|---|---|---|
| bimatoprost formulation A solution | EXPERIMENTAL | Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost solution 0.03 % | ACTIVE_COMPARATOR | Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost formulation A solution | PLACEBO_COMPARATOR | Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost solution 0.03 % | PLACEBO_COMPARATOR | Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost Formulation A | EXPERIMENTAL | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation B | EXPERIMENTAL | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation C | EXPERIMENTAL | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost vehicle solution | PLACEBO_COMPARATOR | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| minoxidil 5% solution | ACTIVE_COMPARATOR | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
| minoxidil 2% solution | ACTIVE_COMPARATOR | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
| Part 1: bimatoprost Formulation A | EXPERIMENTAL | bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Part 1: bimatoprost Formulation B | EXPERIMENTAL | bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Part 2: bimatoprost Formulation C | EXPERIMENTAL | bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
| Name | Type | Description |
|---|---|---|
| bimatoprost formulation A solution | DRUG | Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost solution 0.03 % | DRUG | Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost formulation A solution | DRUG | Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| vehicle of bimatoprost solution 0.03 % | DRUG | Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost Formulation A | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation B | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost Formulation C | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| bimatoprost vehicle solution | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. |
| minoxidil 5% solution | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
| minoxidil 2% solution | DRUG | Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. |
Inclusion Criteria: -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth). Exclusion Criteria: * Damage to eyelid area (scarring) that may prevent growth of eyelashes * Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye) ...
Bimatoprost Formulation A is an investigational small molecule being developed for idiopathic eyelash hypotrichosis and alopecia, including androgenetic alopecia and female pattern hair loss. It is a dermatology asset that has completed clinical trials in these indications.
Bimatoprost Formulation A is being developed by AbbVie Inc., which trades under the ticker ABBV. The company has sponsored clinical trials evaluating the drug in patients with alopecia and eyelash hypotrichosis.
Bimatoprost Formulation A is in Phase 2 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, but the drug remains investigational and has not been approved by the FDA.
Bimatoprost Formulation A has completed three trials: NCT01189279, a Phase 1 safety and pharmacokinetics study in alopecia; NCT01325337, a Phase 2 study in men with androgenic alopecia; and NCT01325350, a Phase 2 study in women with female pattern hair loss. A Phase 3 trial, NCT01698554, evaluated the drug in eyelash hypotrichosis.
Bimatoprost Formulation A is a small molecule that works by targeting prostaglandin receptors, which are involved in hair growth. It is being studied for its ability to promote hair regrowth in conditions like alopecia and eyelash hypotrichosis.
Bimatoprost Formulation A is a new formulation of bimatoprost, the active ingredient in Latisse. It is being developed specifically for eyelash hypotrichosis and alopecia, and has been tested in clinical trials for these conditions.