Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bimatoprost formulation A solution
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 developed by AbbVie Inc. (ABBV) for dermatologic use. It is being studied in alopecia and idiopathic eyelash hypotrichosis. The program is in Phase 2 development, and the formulation has been evaluated in controlled, randomized, double-blind clinical trials.
Bimatoprost Formulation A is being studied for alopecia, including androgenetic alopecia and female pattern hair loss, and for idiopathic eyelash hypotrichosis. These are the indications under investigation in its clinical program. It is not approved for any indication and remains an investigational therapy.
Bimatoprost Formulation A targets PTGFR, the prostaglandin F receptor, and acts as an agonist at that receptor. PTGFR agonism is the mechanism under study in its dermatologic indications. The drug is a small molecule and is not biomarker-selected in its trials.
Bimatoprost Formulation A 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 the formulation in alopecia and idiopathic eyelash hypotrichosis.
Bimatoprost Formulation A is in Phase 2 development. It is investigational and has not been approved by the FDA for any indication. The program includes completed Phase 1, Phase 2, and Phase 3 trials, with no active trials currently listed.
Bimatoprost Formulation A has been studied in completed trials including NCT01698554 in idiopathic eyelash hypotrichosis, NCT01325350 in female pattern hair loss, NCT01325337 in male androgenetic alopecia, and NCT01189279, a Phase 1 pharmacokinetics study in alopecia. Total enrollment across these trials was 655 participants.
Yes. Bimatoprost Formulation A is also known as bimatoprost formulation A solution. Both names refer to the same investigational small molecule developed by AbbVie Inc. (ABBV) for alopecia and idiopathic eyelash hypotrichosis.