Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bimatoprost 0.03% · 4 trials · 4 indications
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.
| Arm | Type | Description |
|---|---|---|
| bimatoprost solution 0.03% | EXPERIMENTAL | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| bimatoprost vehicle solution | PLACEBO_COMPARATOR | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | EXPERIMENTAL | Bimatoprost 0.03% Formulation B Ophthalmic Solution |
| Bimatoprost 0.03% Ophthalmic Solution | ACTIVE_COMPARATOR | Bimatoprost 0.03% Ophthalmic Solution |
| Bimatoprost 0.03% Followed by Bimatoprost 0.03% | EXPERIMENTAL | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| Bimatoprost 0.03% Followed by Vehicle | OTHER | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| Vehicle Followed by Bimatoprost 0.03% | OTHER | Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| Name | Type | Description |
|---|---|---|
| bimatoprost solution 0.03% | DRUG | One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. |
| bimatoprost vehicle solution | DRUG | One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. |
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | DRUG | One drop administered in each eye, every evening, for 12 weeks |
| Bimatoprost 0.03% Ophthalmic Solution | DRUG | One drop administered in each eye, every evening, for 12 weeks |
| Bimatoprost 0.03% solution | DRUG | Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). |
| Vehicle solution | DRUG | Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). |
Inclusion Criteria: * Have inadequate eyelashes Exclusion Criteria: * Any disease/infection/abnormality of the eye or area around the eye * Any ocular surgery within 3 months or anticipated need for ocular surgery during the study * Any permanent eyeliner or implants of any kind or anticipated us...
| 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 0.03% is an ophthalmic small molecule used for glaucoma, ocular hypertension, and hypotrichosis of the eyelashes, including eyelash hypotrichosis. It is being developed by AbbVie Inc. (ABBV) and is currently in Phase 3 clinical development.
Bimatoprost 0.03% is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is being studied for ophthalmology indications including glaucoma and eyelash hypotrichosis.
Bimatoprost 0.03% is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed for glaucoma, ocular hypertension, and eyelash hypotrichosis.
Bimatoprost 0.03% has completed several Phase 3 trials, including NCT00907426 for eyelash hypotrichosis, NCT01099774 for glaucoma and ocular hypertension, NCT01391273 for eyelash hypotrichosis in Japanese patients, and NCT01391286 for chemotherapy-induced eyelash hypotrichosis.
Bimatoprost 0.03% is a specific concentration of the drug bimatoprost. The trials listed for this asset use the 0.03% ophthalmic solution formulation, which is being studied for glaucoma, ocular hypertension, and eyelash hypotrichosis.